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Prior to the COVID-19 what do you need to buy tamiflu pandemic, many countries were making steady progress in tackling tuberculosis (TB), with a 9% reduction in incidence seen between 2015 and 2019 and a 14% drop in deaths in the same period. High-level political commitments at global and national levels were delivering results. However, a new report from WHO shows that access to TB services remains a challenge, and that global what do you need to buy tamiflu targets for prevention and treatment will likely be missed without urgent action and investments.

Approximately 1.4 million people died from TB-related illnesses in 2019. Of the estimated 10 million people who developed TB that year, some 3 million were what do you need to buy tamiflu not diagnosed with the disease, or were not officially reported to national authorities. The situation is even more acute for people with drug-resistant TB.

About 465 000 people were newly diagnosed with drug-resistant TB in 2019 and, of these, less than 40% were able to what do you need to buy tamiflu access treatment. There has also been limited progress in scaling up access to treatment to prevent TB. €œEquitable access to quality and what do you need to buy tamiflu timely diagnosis, prevention, treatment and care remains a challenge,” said Dr Tedros Adhanom Ghebreyesus, Director-General of WHO.

“Accelerated action is urgently needed worldwide if we are to meet our targets by 2022.”About 14 million people were treated for TB in the period 2018-2019, just over one-third of the way towards the 5-year target (2018-2022) of 40 million, according to the report. Some 6.3 million people started TB preventive treatment in 2018-2019, about one-fifth of the way towards the 5-year target what do you need to buy tamiflu of 30 million.Funding is a major issue. In 2020, funding for TB prevention, diagnosis, treatment and care reached US$ 6.5 billion, representing only half of the US$ 13 billion target agreed by world leaders in the UN Political Declaration on TB.The COVID-19 pandemic and TBDisruptions in services caused by the COVID-19 pandemic have led to further setbacks.

In many countries, human, financial and other resources have been reallocated what do you need to buy tamiflu from TB to the COVID-19 response. Data collection and reporting systems have also been negatively impacted.According to the new report, data collated from over 200 countries has shown significant reductions in TB case notifications, with 25-30% drops reported in 3 high burden countries – India, Indonesia, the Philippines – between January and June 2020 compared to the same 6-month period in 2019. These reductions in case notifications could lead to a dramatic increase in additional TB deaths, according to WHO modelling.

However, in line with what do you need to buy tamiflu WHO guidance, countries have taken measures to mitigate the impact of COVID-19 on essential TB services, including by strengthening infection control. A total of 108 countries – including 21 countries with a high TB burden – have expanded the use of digital technologies to provide remote advice and support. To reduce the need for visits to health facilities, many countries are encouraging home-based treatment, all-oral treatments for people with drug-resistant TB, provision of TB preventive treatment, and ensuring people with TB maintain an adequate supply of drugs.“In the face of the pandemic, countries, civil society what do you need to buy tamiflu and other partners have joined forces to ensure that essential services for both TB and COVID-19 are maintained for those in need,” said Dr Tereza Kaseva, Director of WHO’s Global TB Programme.

€œThese efforts are vital to strengthen health systems, ensure health for all, and save lives.”A recent progress report from the UN Secretary General outlines 10 priority actions for Member States and other stakeholders to close gaps in TB care, financing and research, as well as advance multisectoral action and accountability, including in the context of the COVID-19 pandemic.Note for the editorsGlobal targetsIn 2014 and 2015, all Member States of WHO and the UN adopted the UN Sustainable Development Goals (SDGs) and WHO’s End TB Strategy. The SDGs and End TB what do you need to buy tamiflu Strategy both include targets and milestones for large reductions in TB incidence, TB deaths and costs faced by TB patients and their households.TB is included under Goal 3 Target 3.3 of the SDGs which aims to “end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases” by the year 2030. The WHO End TB Strategy aims for a 90 per cent reduction in TB deaths and an 80 per cent reduction in the TB incidence rate by 2030, compared to the 2015 baseline.

Milestones for 2020 include a what do you need to buy tamiflu 20% reduction in the TB incidence rate and a 35% reduction in TB deaths.Efforts to step up political commitment in the fight against TB intensified in 2017 and 2018 culminating, in September 2018, in the first-ever high-level meeting on TB at the UN General Assembly. The outcome was a political declaration in which commitments to the SDGs and End TB Strategy were reaffirmed. The UN Political Declaration on TB also what do you need to buy tamiflu included 4 new targets for the period 2018-2022.

Treat 40 million people for TB disease Reach at least 30 million people with TB preventive treatment for a latent TB infection Mobilize at least US$13 billion annually for universal access to TB diagnosis, treatment and care Mobilize at least US$2 billion annually for TB researchProgress towards global targetsAccording to the new report, the WHO European Region is on track to achieve key 2020 targets of the WHO End TB Strategy, with reductions in incidence and deaths of 19% and 31%, respectively, over the last 5-year period. The African Region has also made impressive gains, with corresponding reductions of 16% and 19% in the same timeframe. On a global scale, however, the pace of progress has lagged, and critical 2020 milestones of the End TB Strategy will what do you need to buy tamiflu be missed.FinancingAs in previous years, most available TB funding (85%) in 2020 came from domestic sources, with Brazil, Russian Federation, India, China and South Africa providing 57% of the global total.

International donor funding increased from US$ 900 000 in 2019 to US$ 1 billion in 2020. The Global Fund to Fight AIDS, Tuberculosis and Malaria was the single largest source of international TB financing in 2020, while the United States remains the biggest bilateral funder of efforts to end TB.Research and innovationReaching the 2030 global TB targets will require technological breakthroughs by what do you need to buy tamiflu 2025. The world needs affordable and accessible rapid point-of-care tests, as well as new, safer and more effective treatments and vaccines.

To meet these challenges, Member States called on WHO in 2018 to develop a Global strategy for TB research and innovation that lays out what do you need to buy tamiflu key steps that governments and non-state actors can undertake. The strategy was adopted by the World Health Assembly in August 2020.Multisectoral action and accountabilityFurther progress towards ending TB will depend on action across sectors, underscoring the importance of the implementation of WHO’s multisectoral accountability framework on TB. In 2019 and 2020, WHO worked with high TB-burden countries to ensure the inclusion of accountability mechanisms in national budget planning and pursuing assessment during high-level missions and what do you need to buy tamiflu joint TB programme reviews with engagement of civil society representatives.

TB factsTuberculosis (TB) , the world’s deadliest infectious killer, is caused by bacteria (Mycobacterium tuberculosis) that most often affect the lungs. It can spread when people who are sick with TB expel what do you need to buy tamiflu bacteria into the air – for example, by coughing. Approximately 90 percent of those who fall sick with TB each year live in 30 countries.

Most people who develop the disease are adults, and there are more cases among men than women.TB is preventable and curable. About 85% of people who develop TB disease can be successfully treated with a 6-month drug regimen. Treatment has the added benefit of curtailing onward transmission of infection.Since 2000, TB treatment has averted more than 60 million deaths – although with access to universal health coverage still falling short, many millions have also missed out on diagnosis and care..

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I would interpret this as an effort to make sure that distribution tamiflu side effects rash is equitable and timely," he said. "The people in this group tamiflu side effects rash are among the most reputable public health advocates in the state."As such, its finding that a particular vaccine was suitable or not suitable could have an outsize impact nationwide.The group includes current and former members of the federal Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, Klausner said, so any disagreement with the federal panel "could have substantial impact on that particular vaccine product."New York Gov. Andrew Cuomo last month appointed a similar independent task force.At most, 45 million doses will tamiflu side effects rash be available nationwide before the end of this year from the two most advanced vaccines, Newsom said. Each person must receive two doses, three weeks apart.If California were to receive 12% of the doses, commensurate with its percentage of the nation's population, that would be 5.4 million doses, or enough to treat 2.7 million of the state's nearly 40 million residents.Most would go to front-line medical workers and first responders, he said, then to the most vulnerable in the tamiflu side effects rash population.Newsom's announcement drew quick criticism from Republican state lawmakers, despite the governor's contention that the panel is needed whoever is president."Politicizing the efficacy of a vaccine is shameful," tweeted Sen.

Melissa Melendez, who said the governor "used the virus to keep people from working, kids from going to school (and) families from being able to attend funerals."Newsom is "suggesting we can't trust the FDA (but) Of course, we'll continue trusting the FDA for every other drug whose distribution doesn't threaten his hold on power," tweeted Assemblyman Kevin Kiley, who has a court hearing this week challenging the governor's authority to impose virus restrictions.Newsom said the distribution and record-keeping logistics alone are massive, including a requirement that the vaccines be kept in continuous cold storage until they are administered.One of the two leading vaccines requires "ultra cold" storage — think tamiflu side effects rash dry ice — of minus 70 Celsius, or minus 94 degrees Fahrenheit. The other needs a minus 20 Celsius, or minus 4 degrees Fahrenheit."They need to be tamiflu side effects rash stored in an extraordinarily challenging environment," Newsom said, though the state has done so before with other medications. But he said that's why the state needs an expert panel that understands the "panoply of issues that will be required to ultimately advance this effort."California last week gave the federal Centers for Disease Control and Prevention its early plans for how it would handle and distribute the vaccine, and in return received nearly $29 million to continue its planning efforts.California is one of five jurisdictions doing what Newsom called "micro-planning" for mass distributions, which he predicted could come as soon as next spring, tamiflu side effects rash is more likely next summer, but could be as late as next fall.The advisory group should be empowered not only to sign off on the safety of a vaccine, Klausner said, but to make recommendations on whether vaccines should be mandatory in some instances, and to guide a complicated distribution process that will likely require readiness by every clinic, pharmacy and health department.It's possible that might make it necessary to "activate the National Guard or some other type of human resource pool to make sure the vaccine can be distributed quickly and effectively," Klausner said.Health insurance premiums for benchmark Affordable Care Act exchange plans will decrease in 2021 for the third year in a row, and most shoppers will have more plan choices, CMS said Monday.The average premium for the benchmark health insurance plan on HealthCare.gov for a 27-year-old will decline by about 2% to $369 per month compared with plans sold this year. For a family of four, premiums will decrease 2% to $1,486, though most people shopping on the exchanges receive subsidies to help afford the premium costs.But "middle-income Americans continue to struggle to afford coverage," CMS said in a statement.The number of health insurers selling plans in 2021 will increase to 181 insurers from 175 in 2020.The lower premiums and added insurance companies show the federal insurance marketplace continues to stabilize after a rough few years of regulatory uncertainty, premium hikes and dwindling choice of health plans.Even so, the Senate is on schedule to confirm Judge Amy tamiflu side effects rash Coney Barrett before the justices hear arguments on Nov.

10 in California v. Texas, a case tamiflu side effects rash in which Republican attorneys general and the Trump administration argue the entire ACA should be struck down because Congress zeroed out the individual mandate. The lawsuit threatens to topple the ACA and eliminate health insurance for nearly 11 million people enrolled in exchange coverage and millions more with insurance under Medicaid expansion.Open tamiflu side effects rash enrollment for 2020 coverage begins on Nov. 1 and ends tamiflu side effects rash Dec.

15 in states that use the federal HealthCare.gov exchange.In 2021, the average premium for the benchmark plan, which is the second-lowest-cost silver plan, will decline by double-digit percentages for a 27-year-old in four states—Iowa, Maine, New Hampshire and Wyoming tamiflu side effects rash. On a percentage basis, Iowa's premiums will decrease the most of any HealthCare.gov state at 29%.Twenty-two more health insurers will sell plans on the tamiflu side effects rash federally run exchange in 2021 than in 2020. The portion of counties with only a tamiflu side effects rash single issuer dropped from 24% in 2020 to 9% in 2021, CMS said in a statement. About 4% tamiflu side effects rash of enrollees will have access to only one insurer, compared with 12% in 2020."More than three-quarters of HealthCare.gov enrollees will have access to at least three issuers in 2021," CMS said in a statement.Most people who purchase coverage on the exchanges are eligible for a subsidy to help cover their premium costs.

These advance premium tax credits are available tamiflu side effects rash to people with incomes of less than 400% of the federal poverty level. In 2020, 88% of HealthCare.gov enrollees were eligible for the subsidy tamiflu side effects rash. Those who aren't eligible, however, must shoulder the entire cost.CMS projects the average maximum tamiflu side effects rash premium tax credit in 2021 for all eligible HealthCare.gov enrollees to be $509. More than 70% of exchange enrollees in 2020 would have access to a health plan of the same metal level that costs less than $75 after premium tax credits in 2021, the CMS said..

California won't allow any distribution of new what do you need to buy tamiflu coronavirus vaccines in the nation's most populous state until it is reviewed by the state's own panel of experts, Gov. Gavin Newsom said Monday.Vaccinations for the pandemic what do you need to buy tamiflu "will move at the speed of trust," said Newsom, a Democrat, and the state wants its own independent review no matter who wins the presidential election next month."Of course we won't take anyone's word for it," Newsom said as he named 11 doctors and scientists to review any rollout of vaccines by the federal government or vaccine developers. They hail from top California universities and medical providers, along with state and local public health officials.The pledge raises the possibility that California residents might what do you need to buy tamiflu not receive a vaccine as distribution begins in other states, though the governor said widespread vaccinations are unrealistic until sometime next year.While there is always a risk that the vaccine could be delayed only in California, Dr. Jeffrey Klausner, a professor of epidemiology at the UCLA Fielding School of what do you need to buy tamiflu Public Health, said Newsom named a renowned group that should be able to quickly make credible decisions."I wouldn't interpret this as a delay in distribution.

I would what do you need to buy tamiflu interpret this as an effort to make sure that distribution is equitable and timely," he said. "The people what do you need to buy tamiflu in this group are among the most reputable public health advocates in the state."As such, its finding that a particular vaccine was suitable or not suitable could have an outsize impact nationwide.The group includes current and former members of the federal Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, Klausner said, so any disagreement with the federal panel "could have substantial impact on that particular vaccine product."New York Gov. Andrew Cuomo what do you need to buy tamiflu last month appointed a similar independent task force.At most, 45 million doses will be available nationwide before the end of this year from the two most advanced vaccines, Newsom said. Each person must receive two doses, three weeks apart.If California were to receive 12% of the doses, commensurate with its percentage of the nation's population, that would be 5.4 million what do you need to buy tamiflu doses, or enough to treat 2.7 million of the state's nearly 40 million residents.Most would go to front-line medical workers and first responders, he said, then to the most vulnerable in the population.Newsom's announcement drew quick criticism from Republican state lawmakers, despite the governor's contention that the panel is needed whoever is president."Politicizing the efficacy of a vaccine is shameful," tweeted Sen.

Melissa Melendez, who said the governor "used the virus to keep people from working, kids from going to school (and) families from being able to attend funerals."Newsom is "suggesting we can't trust the FDA (but) what do you need to buy tamiflu Of course, we'll continue trusting the FDA for every other drug whose distribution doesn't threaten his hold on power," tweeted Assemblyman Kevin Kiley, who has a court hearing this week challenging the governor's authority to impose virus restrictions.Newsom said the distribution and record-keeping logistics alone are massive, including a requirement that the vaccines be kept in continuous cold storage until they are administered.One of the two leading vaccines requires "ultra cold" storage — think dry ice — of minus 70 Celsius, or minus 94 degrees Fahrenheit. The other needs a minus 20 Celsius, or minus 4 degrees Fahrenheit."They need to be stored in an extraordinarily what do you need to buy tamiflu challenging environment," Newsom said, though the state has done so before with other medications. But he said that's why the state needs an expert panel that understands the "panoply of issues that will be required to ultimately advance this effort."California last week gave the federal Centers for Disease Control and Prevention its early plans for how it would handle and distribute the vaccine, and in return received nearly $29 million to continue its planning efforts.California is one of five jurisdictions doing what Newsom called "micro-planning" for mass distributions, which he what do you need to buy tamiflu predicted could come as soon as next spring, is more likely next summer, but could be as late as next fall.The advisory group should be empowered not only to sign off on the safety of a vaccine, Klausner said, but to make recommendations on whether vaccines should be mandatory in some instances, and to guide a complicated distribution process that will likely require readiness by every clinic, pharmacy and health department.It's possible that might make it necessary to "activate the National Guard or some other type of human resource pool to make sure the vaccine can be distributed quickly and effectively," Klausner said.Health insurance premiums for benchmark Affordable Care Act exchange plans will decrease in 2021 for the third year in a row, and most shoppers will have more plan choices, CMS said Monday.The average premium for the benchmark health insurance plan on HealthCare.gov for a 27-year-old will decline by about 2% to $369 per month compared with plans sold this year. For a family of four, premiums will decrease 2% to $1,486, though most people shopping on the exchanges receive subsidies to help afford the premium costs.But "middle-income Americans continue to struggle to afford coverage," CMS said in a statement.The number of health insurers selling plans in 2021 will increase to 181 insurers from 175 in 2020.The lower premiums and added insurance companies show the federal insurance marketplace continues to stabilize after a rough few years of regulatory uncertainty, premium hikes and dwindling choice of health plans.Even so, the Senate is on schedule to confirm Judge Amy Coney Barrett before the what do you need to buy tamiflu justices hear arguments on Nov.

10 in California v. Texas, a what do you need to buy tamiflu case in which Republican attorneys general and the Trump administration argue the entire ACA should be struck down because Congress zeroed out the individual mandate. The lawsuit threatens to topple the ACA and eliminate health insurance for nearly 11 million people enrolled in exchange coverage and millions more with insurance what do you need to buy tamiflu under Medicaid expansion.Open enrollment for 2020 coverage begins on Nov. 1 and what do you need to buy tamiflu ends Dec.

15 in states that use the federal HealthCare.gov exchange.In 2021, the average premium for the benchmark plan, which is the second-lowest-cost silver plan, will decline by double-digit percentages for a 27-year-old in four states—Iowa, Maine, New Hampshire and what do you need to buy tamiflu Wyoming. On a percentage basis, Iowa's premiums will decrease the most of any what do you need to buy tamiflu HealthCare.gov state at 29%.Twenty-two more health insurers will sell plans on the federally run exchange in 2021 than in 2020. The portion of counties with only a single issuer dropped from 24% in 2020 to 9% in 2021, what do you need to buy tamiflu CMS said in a statement. About 4% of enrollees will have access to only one insurer, compared with 12% in 2020."More than three-quarters of HealthCare.gov enrollees will have access to at least three issuers in 2021," CMS said in a statement.Most people who purchase what do you need to buy tamiflu coverage on the exchanges are eligible for a subsidy to help cover their premium costs.

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If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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Over 12,000 home health agencies served 5 million disabled and older does tamiflu make you tired Americans in 2018. Home health aides help their clients with the tasks of daily living, like eating and showering, as well as with clinical tasks, like taking blood pressure and leading physical therapy exercises. Medicare relies on home health care services because they help patients discharged from the hospital and skilled nursing does tamiflu make you tired facilities recover but at a much lower cost.

Together, Medicare and Medicaid make up 76% of all home health spending.Home health care workers serve a particularly important role in rural areas. As rural areas lose physicians and hospitals, home health agencies does tamiflu make you tired often replace primary care providers. The average age of residents living in rural counties is seven years older than in urban counties, and this gap is growing.

The need for home health agencies serving the elderly in rural areas will continue to grow over the coming decades.Rural home health agencies face unique challenges. Low concentrations of people are dispersed over large geographic areas leading to long travel times for workers to drive to does tamiflu make you tired clients’ homes. Agencies in rural areas also have difficulties recruiting and maintaining a workforce.

Due to these difficulties, agencies may not be able to serve all rural beneficiaries, initiate care on time, or deliver all covered services.Congress has supported measures to encourage home health agencies to work in rural areas since the 1980s by using rural does tamiflu make you tired add-on payments. A rural add-on is a percentage increase on top of per visit and episode-of-care payments. When a home health aide works in a rural county, Medicare pays their home health agency a does tamiflu make you tired standard fee plus a rural add-on.

With a 5% add-on, Medicare would pay $67.78 for an aide home visit in a city and $71.17 for the same care in a rural area.Home health care workers serve a particularly important role in rural areas. As rural areas lose physicians and hospitals, home health agencies often replace primary care providers.Rural add-on payments have fluctuated based on Congressional budgets and political priorities. From 2003 to 2019, the does tamiflu make you tired amount Medicare paid agencies changed eight times.

For instance, the add-on dropped from 10% to nothing in April 2003. Then, in April 2004, Congress set the rural add-on to 5%.The variation in payments does tamiflu make you tired created a natural experiment for researchers. Tracy Mroz and colleagues assessed how rural add-ons affected the supply of home health agencies in rural areas.

They asked if the number of agencies in urban and rural counties varied depending on the presence and dollar amount of rural add-ons between 2002 and 2018. Though rural add-ons have been does tamiflu make you tired in place for over 30 years, researchers had not previously investigated their effect on the availability of home healthcare.The researchers found that rural areas adjacent to urban areas were not affected by rural add-ons. They had similar supply to urban areas whether or not add-ons were in place.

In contrast, isolated rural areas were does tamiflu make you tired affected substantially by add-ons. Without add-ons, the number of agencies in isolated rural areas lagged behind those in urban areas. When the add-ons were at least 5%, the availability of home health in isolated rural does tamiflu make you tired areas was comparable to urban areas.In 2020, Congress implemented a system of payment reform that reimburses home health agencies in rural counties by population density and home health use.

Under the new system, counties with low population densities and low home health use will receive the greatest rural add-on payments. These payments aim to increase and maintain the availability of care in the most vulnerable rural home health markets. Time will tell does tamiflu make you tired if this approach gives sufficient incentive to ensure access to quality care in the nation’s most isolated areas.Photo via Getty ImagesStart Preamble Correction In proposed rule document 2020-13792 beginning on page 39408 in the issue of Tuesday, June 30, 2020, make the following correction.

On page 39408, in the first column, in the DATES section, “August 31, 2020” should read “August 24, 2020”. End Preamble does tamiflu make you tired [FR Doc. C1-2020-13792 Filed 7-17-20.

Over 12,000 home health agencies served 5 what do you need to buy tamiflu million disabled and older Americans in 2018. Home health aides help their clients with the tasks of daily living, like eating and showering, as well as with clinical tasks, like taking blood pressure and leading physical therapy exercises. Medicare relies on home health care services because they help patients discharged from the hospital and skilled nursing what do you need to buy tamiflu facilities recover but at a much lower cost. Together, Medicare and Medicaid make up 76% of all home health spending.Home health care workers serve a particularly important role in rural areas.

As rural areas what do you need to buy tamiflu lose physicians and hospitals, home health agencies often replace primary care providers. The average age of residents living in rural counties is seven years older than in urban counties, and this gap is growing. The need for home health agencies serving the elderly in rural areas will continue to grow over the coming decades.Rural home health agencies face unique challenges. Low concentrations of people are dispersed over large geographic areas leading to long travel times for what do you need to buy tamiflu workers to drive to clients’ homes.

Agencies in rural areas also have difficulties recruiting and maintaining a workforce. Due to these difficulties, agencies may not be able to serve all rural beneficiaries, initiate care on time, or deliver all covered services.Congress has supported measures what do you need to buy tamiflu to encourage home health agencies to work in rural areas since the 1980s by using rural add-on payments. A rural add-on is a percentage increase on top of per visit and episode-of-care payments. When a home health aide works in a rural county, Medicare pays their home health agency a what do you need to buy tamiflu standard fee plus a rural add-on.

With a 5% add-on, Medicare would pay $67.78 for an aide home visit in a city and $71.17 for the same care in a rural area.Home health care workers serve a particularly important role in rural areas. As rural areas lose physicians and hospitals, home health agencies often replace primary care providers.Rural add-on payments have fluctuated based on Congressional budgets and political priorities. From 2003 what do you need to buy tamiflu to 2019, the amount Medicare paid agencies changed eight times. For instance, the add-on dropped from 10% to nothing in April 2003.

Then, in April 2004, Congress set the rural add-on to 5%.The variation in payments created a natural experiment what do you need to buy tamiflu for researchers. Tracy Mroz and colleagues assessed how rural add-ons affected the supply of home health agencies in rural areas. They asked if the number of agencies in urban and rural counties varied depending on the presence and dollar amount of rural add-ons between 2002 and 2018. Though rural add-ons have been what do you need to buy tamiflu in place for over 30 years, researchers had not previously investigated their effect on the availability of home healthcare.The researchers found that rural areas adjacent to urban areas were not affected by rural add-ons.

They had similar supply to urban areas whether or not add-ons were in place. In contrast, isolated rural areas were affected substantially by what do you need to buy tamiflu add-ons. Without add-ons, the number of agencies in isolated rural areas lagged behind those in urban areas. When the add-ons were at least 5%, the availability of home health in isolated rural areas was comparable to urban areas.In 2020, Congress implemented a system of payment reform that reimburses home health agencies in rural counties by population density and home health use what do you need to buy tamiflu.

Under the new system, counties with low population densities and low home health use will receive the greatest rural add-on payments. These payments aim to increase and maintain the availability of care in the most vulnerable rural home health markets. Time will tell if this approach gives sufficient incentive to ensure access to quality care in the nation’s most isolated areas.Photo via Getty ImagesStart Preamble Correction In proposed rule document 2020-13792 beginning on what do you need to buy tamiflu page 39408 in the issue of Tuesday, June 30, 2020, make the following correction. On page 39408, in the first column, in the DATES section, “August 31, 2020” should read “August 24, 2020”.

End Preamble what do you need to buy tamiflu [FR Doc. C1-2020-13792 Filed 7-17-20. 8:45 am]BILLING CODE 1301-00-D.

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UNFPA, the agency specializing in reproductive and maternal health worldwide, is working with 12 partners on the ground to distribute dignity kits, which contain sanitary pads, can you take tylenol cold and flu medicine with tamiflu soap, toothbrushes, toothpaste and towels. These items are helping women and girls maintain their personal hygiene even amid the destruction and displacement.This is essential, community members have emphasized.“Just like I would want my girls to be fed, I would also want them to have these basic hygienic needs”, said Hayat Merhi, a woman with three adolescent daughters whose family was affected by the blast.Pandemic, can you take tylenol cold and flu medicine with tamiflu economic turmoilThe blast and its aftermath comes on top of the COVID-19 pandemic and an economic crisis, years in the making. Job losses have curtailed family spending, even as disease prevention is becoming more urgent than ever.Too often, the needs of women and girls are the first to go unmet.“There was a time when my daughters were using a piece of cloth instead of pads", said Lina Mroueh, who also has three adolescent daughters.UNFPA partners have been canvassing blast-impacted areas as they distribute the dignity kits, speaking with women and girls about their circumstances. The work is challenging, but rewarding, they say.“Bringing light into their broken homes and telling women and girls can you take tylenol cold and flu medicine with tamiflu that their dignity, safety and personal needs matter to the world in these difficult times is the least we can do,” described Rima Al Hussayni, director of Al Mithaq Association.Life-saving informationThe distribution of dignity kits is also an opportunity to address yet another crisis.

Gender-based violence, according to UNFPA.Gender-based violence is known to increase in humanitarian settings and in times of economic stress. Amid the pandemic, many countries are reporting increased violence against women and rising demands for support services.“It is very important can you take tylenol cold and flu medicine with tamiflu to remember that dignity kits are helpful to women and girls, not only for the menstrual hygiene products, soaps and other items, but also as a way to reach women and girls with key messages about sexual and reproductive health and rights, gender-based violence, the prevention of sexual exploitation, and abuse services and information,” said Felicia Jones, UNFPA’s humanitarian coordinator. UNFPAUNFPA and partners are distributing dignity kits to women in Beirut following the devasting explosion.The dignity kits contain referral information to connect survivors with help. The people distributing the kits are also trained to provide this information.In some cases, they explain even more.“We trained our staff to demonstrate how to use and maintain the items in the kit”, said Gabby Fraidy of the Lebanese Council to can you take tylenol cold and flu medicine with tamiflu Resist Violence Against Women.

€œWe had 11-year-old girls who came to us, and our role was to share information about menstruation and explain to them that it is a natural and a biological process that occurs, and that it’s a part of growing up.”Additional vulnerabilitiesAkkarouna and Al Makassed associations are also distributing dignity kits to women and girls with disabilities, who often face additional vulnerabilities and challenges accessing sexual and reproductive health services and commodities.It is estimated that around 12,000 disabled persons have been affected by the blast.The outbreak in Equateur Province emerged in early June and has now spread into another of its 17 health zones, bringing the total number of affected zones to 12. So far, there have been 113 can you take tylenol cold and flu medicine with tamiflu cases and 48 deaths. “The most recently affected area, Bomongo, is the second affected health zone that borders the Republic of Congo, which heightens the chances of this outbreak to spread into another country”, said WHO Spokesperson, Fadéla Chaib, underlining the need for cross-border collaboration and coordination. The risk of the disease spreading as far as Kinshasa is also a can you take tylenol cold and flu medicine with tamiflu very real concern for the UN agency.

One of the affected areas, Mbandaka, is connected to the capital by a busy river route used by thousands every week. Logistical challenges, community resistance This is the second Ebola outbreak in can you take tylenol cold and flu medicine with tamiflu Equateur Province and the 11th overall in the DRC, which recently defeated the disease in its volatile eastern region after a two-year battle. This latest western outbreak first surfaced in the city of Mbandaka, home to more than one million people, and subsequently spread to 11 health zones, with active transmission currently occurring in eight. The health zones all border each other and cover a large and remote can you take tylenol cold and flu medicine with tamiflu area often only accessible by helicopter or boat.

Managing response logistics in can you take tylenol cold and flu medicine with tamiflu Equateur is difficult as communities are very scattered. Many are in deeply forested areas and reaching them requires travelling long distances. In some areas, community resistance is also a can you take tylenol cold and flu medicine with tamiflu challenge, Ms. Chaib added."We learned over years of working on Ebola in DRC how important it is to engage and mobilize communities.

WHO is working with UNICEF can you take tylenol cold and flu medicine with tamiflu in engaging religious, youth and community leaders to raise awareness about Ebola," she said.Health workers on strike The situation has been further complicated by a health worker strike that has affected key response activities for nearly four weeks. Locally based Ebola responders have been protesting against low salaries as well as non-payment since the start of the outbreak. Although some activities have resumed, many are still on hold, making it difficult to get an accurate picture of how can you take tylenol cold and flu medicine with tamiflu the epidemic is evolving and which areas need the most attention. Response ‘grossly underfunded’ WHO and partners have been on the ground since the early days of the outbreak.

More than 90 experts are in Equateur, and additional staff have recently been deployed from the capital, including can you take tylenol cold and flu medicine with tamiflu experts in epidemiology, vaccination, community engagement, infection prevention and control, laboratory and treatment. Nearly one million travellers have been screened, which helped identify some 72 suspected Ebola cases, thus reducing further spread. However, the UN agency warned that can you take tylenol cold and flu medicine with tamiflu response is “grossly underfunded”. WHO has provided some $2.3 million in support so far, and has urged donors to back a $40 million plan by the Congolese government.

This latest Ebola outbreak is unfolding amidst the COVID-19 can you take tylenol cold and flu medicine with tamiflu pandemic. As of Friday, there were more than 10,300 cases and 260 deaths across the vast African nation. While there can you take tylenol cold and flu medicine with tamiflu are several similarities in addressing the two diseases, such as the need to identify and test contacts, isolate cases, and promote effective prevention measures, Ms. Chaib stressed that without extra funding, it will be even harder to defeat Ebola..

UNFPA, the agency specializing in reproductive and maternal health worldwide, is working with 12 partners on the ground to distribute dignity kits, which contain sanitary pads, what do you need to buy tamiflu soap, toothbrushes, toothpaste and towels. These items are helping women what do you need to buy tamiflu and girls maintain their personal hygiene even amid the destruction and displacement.This is essential, community members have emphasized.“Just like I would want my girls to be fed, I would also want them to have these basic hygienic needs”, said Hayat Merhi, a woman with three adolescent daughters whose family was affected by the blast.Pandemic, economic turmoilThe blast and its aftermath comes on top of the COVID-19 pandemic and an economic crisis, years in the making. Job losses have curtailed family spending, even as disease prevention is becoming more urgent than ever.Too often, the needs of women and girls are the first to go unmet.“There was a time when my daughters were using a piece of cloth instead of pads", said Lina Mroueh, who also has three adolescent daughters.UNFPA partners have been canvassing blast-impacted areas as they distribute the dignity kits, speaking with women and girls about their circumstances. The work is challenging, but rewarding, they say.“Bringing light into their broken homes and telling women and girls that their dignity, safety and personal needs matter to the world in these difficult times is the least we can do,” described Rima Al Hussayni, director of Al Mithaq Association.Life-saving informationThe distribution of dignity kits is also an opportunity to address what do you need to buy tamiflu yet another crisis.

Gender-based violence, according to UNFPA.Gender-based violence is known to increase in humanitarian settings and in times of economic stress. Amid the pandemic, many countries what do you need to buy tamiflu are reporting increased violence against women and rising demands for support services.“It is very important to remember that dignity kits are helpful to women and girls, not only for the menstrual hygiene products, soaps and other items, but also as a way to reach women and girls with key messages about sexual and reproductive health and rights, gender-based violence, the prevention of sexual exploitation, and abuse services and information,” said Felicia Jones, UNFPA’s humanitarian coordinator. UNFPAUNFPA and partners are distributing dignity kits to women in Beirut following the devasting explosion.The dignity kits contain referral information to connect survivors with help. The people distributing the kits are also trained to provide this information.In some cases, they explain even more.“We trained our staff to demonstrate how to use and maintain the items in the what do you need to buy tamiflu kit”, said Gabby Fraidy of the Lebanese Council to Resist Violence Against Women.

€œWe had 11-year-old girls who came to us, and our role was to share information about menstruation and explain to them that it is a natural and a biological process that occurs, and that it’s a part of growing up.”Additional vulnerabilitiesAkkarouna and Al Makassed associations are also distributing dignity kits to women and girls with disabilities, who often face additional vulnerabilities and challenges accessing sexual and reproductive health services and commodities.It is estimated that around 12,000 disabled persons have been affected by the blast.The outbreak in Equateur Province emerged in early June and has now spread into another of its 17 health zones, bringing the total number of affected zones to 12. So far, there have been 113 what do you need to buy tamiflu cases and 48 deaths. “The most recently affected area, Bomongo, is the second affected health zone that borders the Republic of Congo, which heightens the chances of this outbreak to spread into another country”, said WHO Spokesperson, Fadéla Chaib, underlining the need for cross-border collaboration and coordination. The risk of the disease spreading as far what do you need to buy tamiflu as Kinshasa is also a very real concern for the UN agency.

One of the affected areas, Mbandaka, is connected to the capital by a busy river route used by thousands every week. Logistical challenges, community resistance This is the second what do you need to buy tamiflu Ebola outbreak in Equateur Province and the 11th overall in the DRC, which recently defeated the disease in its volatile eastern region after a two-year battle. This latest western outbreak first surfaced in the city of Mbandaka, home to more than one million people, and subsequently spread to 11 health zones, with active transmission currently occurring in eight. The health zones all border each other and cover a large and remote area often only accessible what do you need to buy tamiflu by helicopter or boat.

Managing response logistics in Equateur is what do you need to buy tamiflu difficult as communities are very scattered. Many are in deeply forested areas and reaching them requires travelling long distances. In some areas, community resistance is also a challenge, Ms what do you need to buy tamiflu. Chaib added."We learned over years of working on Ebola in DRC how important it is to engage and mobilize communities.

WHO is working with UNICEF in engaging religious, youth and community leaders to raise awareness about Ebola," she said.Health what do you need to buy tamiflu workers on strike The situation has been further complicated by a health worker strike that has affected key response activities for nearly four weeks. Locally based Ebola responders have been protesting against low salaries as well as non-payment since the start of the outbreak. Although some activities have what do you need to buy tamiflu resumed, many are still on hold, making it difficult to get an accurate picture of how the epidemic is evolving and which areas need the most attention. Response ‘grossly underfunded’ WHO and partners have been on the ground since the early days of the outbreak.

More than 90 experts are in what do you need to buy tamiflu Equateur, and additional staff have recently been deployed from the capital, including experts in epidemiology, vaccination, community engagement, infection prevention and control, laboratory and treatment. Nearly one million travellers have been screened, which helped identify some 72 suspected Ebola cases, thus reducing further spread. However, the UN agency warned that response is “grossly underfunded” what do you need to buy tamiflu. WHO has provided some $2.3 million in support so far, and has urged donors to back a $40 million plan by the Congolese government.

This latest Ebola what do you need to buy tamiflu outbreak is unfolding amidst the COVID-19 pandemic. As of Friday, there were more than 10,300 cases and 260 deaths across the vast African nation. While there what do you need to buy tamiflu are several similarities in addressing the two diseases, such as the need to identify and test contacts, isolate cases, and promote effective prevention measures, Ms. Chaib stressed that without extra funding, it will be even harder to defeat Ebola..

Tamiflu farmacia san pablo

Specificity of SARS-CoV-2 Antibody Assays tamiflu farmacia san pablo Both assays measuring pan-Ig antibodies had low numbers of false positives among samples collected in 2017. There were 0 and 1 false positives for the two assays tamiflu farmacia san pablo among 472 samples, results that compared favorably with those obtained with the single IgM anti-N and IgG anti-N assays (Table S3). Because of the low prevalence of SARS-CoV-2 infection in Iceland, we required positive results from both pan-Ig antibody assays for a sample to be considered seropositive (see Supplementary Methods in Supplementary Appendix 1). None of the samples tamiflu farmacia san pablo collected in early 2020 group were seropositive, which indicates that the virus had not spread widely in Iceland before February 2020.

SARS-CoV-2 Antibodies among qPCR-Positive Persons Figure 2. Figure 2 tamiflu farmacia san pablo. Antibody Prevalence and Titers among qPCR-Positive Cases as a Function of Time since Diagnosis by qPCR. Shown are the percentages of samples positive for both pan-Ig antibody assays and the antibody titers tamiflu farmacia san pablo.

Red denotes the count or percentage of samples among persons during their hospitalization (249 samples from 48 persons), and blue denotes the count or percentage of samples among persons after they were declared recovered (1853 samples from 1215 persons). Vertical bars tamiflu farmacia san pablo denote 95% confidence intervals. The dashed lines indicated the thresholds for a test to be declared positive. OD denotes optical density, and RBD receptor tamiflu farmacia san pablo binding domain.Table 1.

Table 1. Prevalence of SARS-CoV-2 Antibodies by Sample Collection as Measured by Two Pan-Ig Antibody tamiflu farmacia san pablo Assays. Twenty-five days after diagnosis by qPCR, more than 90% of samples from recovered persons tested positive tamiflu farmacia san pablo with both pan-Ig antibody assays, and the percentage of persons testing positive remained stable thereafter (Figure 2 and Fig. S2).

Hospitalized persons seroconverted more frequently and quickly after qPCR diagnosis than did nonhospitalized persons (Figure 2 tamiflu farmacia san pablo and Fig. S3). Of 1215 persons who had recovered (on the basis of results for the most recently obtained sample from tamiflu farmacia san pablo persons for whom we had multiple samples), 1107 were seropositive (91.1%. 95% confidence interval [CI], 89.4 to 92.6) (Table 1 and Table S4).

Since some diagnoses may have been made on the basis of false positive qPCR results, we determined that 91.1% represents the lower bound of sensitivity of the combined pan-Ig tests for the detection of SARS-CoV-2 antibodies among recovered tamiflu farmacia san pablo persons. Table 2. Table 2 tamiflu farmacia san pablo. Results of Repeated Pan-Ig Antibody Tests among Recovered qPCR-Diagnosed Persons.

Among the 487 recovered persons tamiflu farmacia san pablo with two or more samples, 19 (4%) had different pan-Ig antibody test results at different time points (Table 2 and Fig. S4). It is notable that of the 22 persons with an early sample that tested negative for both tamiflu farmacia san pablo pan-Ig antibodies, 19 remained negative at the most recent test date (again, for both antibodies). One person tested positive for both pan-Ig antibodies in the first test and negative for both in the most recent test.

The longitudinal changes in antibody levels among recovered persons were consistent tamiflu farmacia san pablo with the cross-sectional results (Fig. S5). Antibody levels were higher in the last sample than in the first sample when the antibodies were measured with the two pan-Ig assays, slightly lower than in the first sample when measured with IgG anti-N and IgG anti-S1 assays, and substantially lower than in the first sample when measured with IgM anti-N and IgA anti-S1 assays. IgG anti-N, IgM anti-N, IgG anti-S1, and IgA anti-S1 antibody levels were correlated among the qPCR-positive persons (Figs.

S5 and S6 and Table S5). Antibody levels measured with both pan-Ig antibody assays increased over the first 2 months after qPCR diagnosis and remained at a plateau over the next 2 months of the study. IgM anti-N antibody levels increased rapidly soon after diagnosis and then fell rapidly and were generally not detected after 2 months. IgA anti-S1 antibodies decreased 1 month after diagnosis and remained detectable thereafter.

IgG anti-N and anti-S1 antibody levels increased during the first 6 weeks after diagnosis and then decreased slightly. SARS-CoV-2 Infection in Quarantine Table 3. Table 3. SARS-CoV-2 Infection among Quarantined Persons According to Exposure Type and Presence of Symptoms.

Of the 1797 qPCR-positive Icelanders, 1088 (61%) were in quarantine when SARS-CoV-2 infection was diagnosed by qPCR. We tested for antibodies among 4222 quarantined persons who had not tested qPCR-positive (they had received a negative result by qPCR or had simply not been tested). Of those 4222 quarantined persons, 97 (2.3%. 95% CI, 1.9 to 2.8) were seropositive (Table 1).

Those with household exposure were 5.2 (95% CI, 3.3 to 8.0) times more likely to be seropositive than those with other types of exposure (Table 3). Similarly, a positive result by qPCR for those with household exposure was 5.2 (95% CI, 4.5 to 6.1) times more likely than for those with other types of exposure. When these two sets of results (qPCR-positive and seropositive) were combined, we calculated that 26.6% of quarantined persons with household exposure and 5.0% of quarantined persons without household exposure were infected. Those who had symptoms during quarantine were 3.2 (95% CI, 1.7 to 6.2) times more likely to be seropositive and 18.2 times (95% CI, 14.8 to 22.4) more likely to test positive with qPCR than those without symptoms.

We also tested persons in two regions of Iceland affected by cluster outbreaks. In a SARS-CoV-2 cluster in Vestfirdir, 1.4% of residents were qPCR-positive and 10% of residents were quarantined. We found that none of the 326 persons outside quarantine who had not been tested by qPCR (or who tested negative) were seropositive. In a cluster in Vestmannaeyjar, 2.3% of residents were qPCR-positive and 13% of residents were quarantined.

Of the 447 quarantined persons who had not received a qPCR-positive result, 4 were seropositive (0.9%. 95% CI, 0.3 to 2.1). Of the 663 outside quarantine in Vestmannaeyjar, 3 were seropositive (0.5%. 95% CI, 0.1 to 0.2%).

SARS-CoV-2 Seroprevalence in Iceland None of the serum samples collected from 470 healthy Icelanders between February 18 and March 9, 2020, tested positive for both pan-Ig antibodies, although four were positive for the pan-Ig anti-N assay (0.9%), a finding that suggests that the virus had not spread widely in Iceland before March 9. Of the 18,609 persons tested for SARS-CoV-2 antibodies through contact with the Icelandic health care system for reasons other than Covid-19, 39 were positive for both pan-Ig antibody assays (estimated seroprevalence by weighting the sample on the basis of residence, sex, and 10-year age category, 0.3%. 95% CI, 0.2 to 0.4). There were regional differences in the percentages of qPCR-positive persons across Iceland that were roughly proportional to the percentage of people quarantined (Table S6).

However, after exclusion of the qPCR-positive and quarantined persons, the percentage of persons who tested positive for SARS-CoV-2 antibodies did not correlate with the percentage of those who tested positive by qPCR. The estimated seroprevalence in the random sample collection from Reykjavik (0.4%. 95% CI, 0.3 to 0.6) was similar to that in the Health Care group (0.3%. 95% CI, 0.2 to 0.4) (Table S6).

We calculate that 0.5% of the residents of Iceland have tested positive with qPCR. The 2.3% with SARS-CoV-2 seroconversion among persons in quarantine extrapolates to 0.1% of Icelandic residents. On the basis of this finding and the seroprevalence from the Health Care group, we estimate that 0.9% (95% CI, 0.8 to 0.9) of the population of Iceland has been infected by SARS-CoV-2. Approximately 56% of all SARS-CoV-2 infections were therefore diagnosed by qPCR, 14% occurred in quarantine without having been diagnosed with qPCR, and the remaining 30% of infections occurred outside quarantine and were not detected by qPCR.

Deaths from Covid-19 in Iceland In Iceland, 10 deaths have been attributed to Covid-19, which corresponds to 3 deaths per 100,000 nationwide. Among the qPCR-positive cases, 0.6% (95% CI, 0.3 to 1.0) were fatal. Using the 0.9% prevalence of SARS-CoV-2 infection in Iceland as the denominator, however, we calculate an infection fatality risk of 0.3% (95% CI, 0.2 to 0.6). Stratified by age, the infection fatality risk was substantially lower in those 70 years old or younger (0.1%.

95% CI, 0.0 to 0.3) than in those over 70 years of age (4.4%. 95% CI, 1.9 to 8.4) (Table S7). Age, Sex, Clinical Characteristics, and Antibody Levels Table 4. Table 4.

Association of Existing Conditions and Covid-19 Severity with SARS-CoV-2 Antibody Levels among Recovered Persons. SARS-CoV-2 antibody levels were higher in older people and in those who were hospitalized (Table 4, and Table S8 [described in Supplementary Appendix 1 and available in Supplementary Appendix 2]). Pan-Ig anti–S1-RBD and IgA anti-S1 levels were lower in female persons. Of the preexisting conditions, and after adjustment for multiple testing, we found that body-mass index, smoking status, and use of antiinflammatory medication were associated with SARS-CoV-2 antibody levels.

Body-mass index correlated positively with antibody levels. Smokers and users of antiinflammatory medication had lower antibody levels. With respect to clinical characteristics, antibody levels were most strongly associated with hospitalization and clinical severity, followed by clinical symptoms such as fever, maximum temperature reading, cough, and loss of appetite. Severity of these individual symptoms, with the exception of loss of energy, was associated with higher antibody levels.To the Editor.

Rapid and accurate diagnostic tests are essential for controlling the ongoing Covid-19 pandemic. Although the current standard involves testing of nasopharyngeal swab specimens by quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) to detect SARS-CoV-2, saliva specimens may be an alternative diagnostic sample.1-4 Rigorous evaluation is needed to determine how saliva specimens compare with nasopharyngeal swab specimens with respect to sensitivity in detection of SARS-CoV-2 during the course of infection. A total of 70 inpatients with Covid-19 provided written informed consent to participate in our study (see the Methods section in Supplementary Appendix 1, available with the full text of this letter at NEJM.org). After Covid-19 was confirmed with a positive nasopharyngeal swab specimen at hospital admission, we obtained additional samples from the patients during hospitalization.

We tested saliva specimens collected by the patients themselves and nasopharyngeal swabs collected from the patients at the same time point by health care workers. Figure 1. Figure 1. SARS-CoV-2 RNA Titers in Saliva Specimens and Nasopharyngeal Swab Specimens.

Samples were obtained from 70 hospital inpatients who had a diagnosis of Covid-19. Panel A shows SARS-CoV-2 RNA titers in the first available nasopharyngeal and saliva samples. The lines indicate samples from the same patient. Results were compared with the use of a Wilcoxon signed-rank test (P<0.001).

Panel B shows percentages of positivity for SARS-CoV-2 in tests of the first matched nasopharyngeal and saliva samples at 1 to 5 days, 6 to 10 days, and 11 or more days (maximum, 53 days) after the diagnosis of Covid-19. Panel C shows longitudinal SARS-CoV-2 RNA copies per milliliter in 97 saliva samples, according to days since symptom onset. Each circle represents a separate sample. Dashed lines indicate additional samples from the same patient.

The red line indicates a negative saliva sample that was followed by a positive sample at the next collection of a specimen. Panel D shows longitudinal SARS-CoV-2 RNA copies per milliliter in 97 nasopharyngeal swab specimens, according to days since symptom onset. The red lines indicate negative nasopharyngeal swab specimens there were followed by a positive swab at the next collection of a specimen. The gray area in Panels C and D indicates samples that were below the lower limit of detection of 5610 virus RNA copies per milliliter of sample, which is at cycle threshold 38 of our quantitative reverse-transcriptase polymerase chain reaction assay targeting the SARS-CoV-2 N1 sequence recommended by the Centers for Disease Control and Prevention.

To analyze these data, we used a linear mixed-effects regression model (see Supplementary Appendix 1) that accounts for the correlation between samples collected from the same person at a single time point (i.e., multivariate response) and the correlation between samples collected across time from the same patient (i.e., repeated measures). All the data used to generate this figure, including the raw cycle thresholds, are provided in Supplementary Data 1 in Supplementary Appendix 2.Using primer sequences from the Centers for Disease Control and Prevention, we detected more SARS-CoV-2 RNA copies in the saliva specimens (mean log copies per milliliter, 5.58. 95% confidence interval [CI], 5.09 to 6.07) than in the nasopharyngeal swab specimens (mean log copies per milliliter, 4.93. 95% CI, 4.53 to 5.33) (Figure 1A, and Fig.

S1 in Supplementary Appendix 1). In addition, a higher percentage of saliva samples than nasopharyngeal swab samples were positive up to 10 days after the Covid-19 diagnosis (Figure 1B). At 1 to 5 days after diagnosis, 81% (95% CI, 71 to 96) of the saliva samples were positive, as compared with 71% (95% CI, 67 to 94) of the nasopharyngeal swab specimens. These findings suggest that saliva specimens and nasopharyngeal swab specimens have at least similar sensitivity in the detection of SARS-CoV-2 during the course of hospitalization.

Because the results of testing of nasopharyngeal swab specimens to detect SARS-CoV-2 may vary with repeated sampling in individual patients,5 we evaluated viral detection in matched samples over time. The level of SARS-CoV-2 RNA decreased after symptom onset in both saliva specimens (estimated slope, −0.11. 95% credible interval, −0.15 to −0.06) (Figure 1C) and nasopharyngeal swab specimens (estimated slope, −0.09. 95% credible interval, −0.13 to −0.05) (Figure 1D).

In three instances, a negative nasopharyngeal swab specimen was followed by a positive swab at the next collection of a specimen (Figure 1D). This phenomenon occurred only once with the saliva specimens (Figure 1C). During the clinical course, we observed less variation in levels of SARS-CoV-2 RNA in the saliva specimens (standard deviation, 0.98 virus RNA copies per milliliter. 95% credible interval, 0.08 to 1.98) than in the nasopharyngeal swab specimens (standard deviation, 2.01 virus RNA copies per milliliter.

95% credible interval, 1.29 to 2.70) (see Supplementary Appendix 1). Recent studies have shown that SARS-CoV-2 can be detected in the saliva of asymptomatic persons and outpatients.1-3 We therefore screened 495 asymptomatic health care workers who provided written informed consent to participate in our prospective study, and we used RT-qPCR to test both saliva and nasopharyngeal samples obtained from these persons. We detected SARS-CoV-2 RNA in saliva specimens obtained from 13 persons who did not report any symptoms at or before the time of sample collection. Of these 13 health care workers, 9 had collected matched nasopharyngeal swab specimens by themselves on the same day, and 7 of these specimens tested negative (Fig.

S2). The diagnosis in the 13 health care workers with positive saliva specimens was later confirmed in diagnostic testing of additional nasopharyngeal samples by a CLIA (Clinical Laboratory Improvement Amendments of 1988)–certified laboratory. Variation in nasopharyngeal sampling may be an explanation for false negative results, so monitoring an internal control for proper sample collection may provide an alternative evaluation technique. In specimens collected from inpatients by health care workers, we found greater variation in human RNase P cycle threshold (Ct) values in nasopharyngeal swab specimens (standard deviation, 2.89 Ct.

95% CI, 26.53 to 27.69) than in saliva specimens (standard deviation, 2.49 Ct. 95% CI, 23.35 to 24.35). When health care workers collected their own specimens, we also found greater variation in RNase P Ct values in nasopharyngeal swab specimens (standard deviation, 2.26 Ct. 95% CI, 28.39 to 28.56) than in saliva specimens (standard deviation , 1.65 Ct.

95% CI, 24.14 to 24.26) (Fig. S3). Collection of saliva samples by patients themselves negates the need for direct interaction between health care workers and patients. This interaction is a source of major testing bottlenecks and presents a risk of nosocomial infection.

Collection of saliva samples by patients themselves also alleviates demands for supplies of swabs and personal protective equipment. Given the growing need for testing, our findings provide support for the potential of saliva specimens in the diagnosis of SARS-CoV-2 infection. Anne L. Wyllie, Ph.D.Yale School of Public Health, New Haven, CT [email protected]John Fournier, M.D.Yale School of Medicine, New Haven, CTArnau Casanovas-Massana, Ph.D.Yale School of Public Health, New Haven, CTMelissa Campbell, M.D.Maria Tokuyama, Ph.D.Pavithra Vijayakumar, B.A.Yale School of Medicine, New Haven, CTJoshua L.

Warren, Ph.D.Yale School of Public Health, New Haven, CTBertie Geng, M.D.Yale School of Medicine, New Haven, CTM. Catherine Muenker, M.S.Adam J. Moore, M.P.H.Chantal B.F. Vogels, Ph.D.Mary E.

Petrone, B.S.Isabel M. Ott, B.S.Yale School of Public Health, New Haven, CTPeiwen Lu, Ph.D.Arvind Venkataraman, B.S.Alice Lu-Culligan, B.S.Jonathan Klein, B.S.Yale School of Medicine, New Haven, CTRebecca Earnest, M.P.H.Yale School of Public Health, New Haven, CTMichael Simonov, M.D.Rupak Datta, M.D., Ph.D.Ryan Handoko, M.D.Nida Naushad, B.S.Lorenzo R. Sewanan, M.Phil.Jordan Valdez, B.S.Yale School of Medicine, New Haven, CTElizabeth B. White, A.B.Sarah Lapidus, M.S.Chaney C.

Kalinich, M.P.H.Yale School of Public Health, New Haven, CTXiaodong Jiang, M.D., Ph.D.Daniel J. Kim, A.B.Eriko Kudo, Ph.D.Melissa Linehan, M.S.Tianyang Mao, B.S.Miyu Moriyama, Ph.D.Ji E. Oh, M.D., Ph.D.Annsea Park, B.A.Julio Silva, B.S.Eric Song, M.S.Takehiro Takahashi, M.D., Ph.D.Manabu Taura, Ph.D.Orr-El Weizman, B.A.Patrick Wong, M.S.Yexin Yang, B.S.Santos Bermejo, B.S.Yale School of Medicine, New Haven, CTCamila D. Odio, M.D.Yale New Haven Health, New Haven, CTSaad B.

Omer, M.B., B.S., Ph.D.Yale Institute for Global Health, New Haven, CTCharles S. Dela Cruz, M.D., Ph.D.Shelli Farhadian, M.D., Ph.D.Richard A. Martinello, M.D.Akiko Iwasaki, Ph.D.Yale School of Medicine, New Haven, CTNathan D. Grubaugh, Ph.D.Albert I.

Ko, M.D.Yale School of Public Health, New Haven, CT [email protected], [email protected] Supported by the Huffman Family Donor Advised Fund, a Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University, the Yale Institute for Global Health, the Yale School of Medicine, a grant (U19 AI08992, to Dr. Ko) from the National Institute of Allergy and Infectious Diseases, the Beatrice Kleinberg Neuwirth Fund, and a grant (Rubicon 019.181EN.004, to Dr. Vogel) from the Dutch Research Council (NWO). Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org.

This letter was published on August 28, 2020, at NEJM.org. Drs. Grubaugh and Ko contributed equally to this letter. 5 References1.

Kojima N, Turner F, Slepnev V, et al. Self-collected oral fluid and nasal swabs demonstrate comparable sensitivity to clinician collected nasopharyngeal swabs for Covid-19 detection. April 15, 2020 (https://www.medrxiv.org/content/10.1101/2020.04.11.20062372v1). Preprint.Google Scholar2.

Williams E, Bond K, Zhang B, Putland M, Williamson DA. Saliva as a non-invasive specimen for detection of SARS-CoV-2. J Clin Microbiol 2020;58(8):e00776-20-e00776-20.3. Pasomsub E, Watcharananan SP, Boonyawat K, et al.

Saliva sample as a non-invasive specimen for the diagnosis of coronavirus disease 2019. A cross-sectional study. Clin Microbiol Infect 2020 May 15 (Epub ahead of print).4. Vogels CBF, Brackney D, Wang J, et al.

SalivaDirect. Simple and sensitive molecular diagnostic test for SARS-CoV-2 surveillance. August 4, 2020 (https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v1). Preprint.Google Scholar5.

Zou L, Ruan F, Huang M, et al. SARS-CoV-2 viral load in upper respiratory specimens of infected patients. N Engl J Med 2020;382:1177-1179.Trial Population Table 1. Table 1.

Demographic Characteristics of the Participants in the NVX-CoV2373 Trial at Enrollment. The trial was initiated on May 26, 2020. 134 participants underwent randomization between May 27 and June 6, 2020, including 3 participants who were to serve as backups for sentinel dosing and who immediately withdrew from the trial without being vaccinated (Fig. S1).

Of the 131 participants who received injections, 23 received placebo (group A), 25 received 25-μg doses of rSARS-CoV-2 (group B), 29 received 5-μg doses of rSARS-CoV-2 plus Matrix-M1, including three sentinels (group C), 28 received 25-μg doses of rSARS-CoV-2 plus Matrix-M1, including three sentinels (group D), and 26 received a single 25-μg dose of rSARS-CoV-2 plus Matrix-M1 followed by a single dose of placebo (group E). All 131 participants received their first vaccination on day 0, and all but 3 received their second vaccination at least 21 days later. Exceptions include 2 in the placebo group (group A) who withdrew consent (unrelated to any adverse event) and 1 in the 25-μg rSARS-CoV-2 + Matrix-M1 group (group D) who had an unsolicited adverse event (mild cellulitis. See below).

Demographic characteristics of the participants are presented in Table 1. Of note, missing data were infrequent. Safety Outcomes No serious adverse events or adverse events of special interest were reported, and vaccination pause rules were not implemented. As noted above, one participant did not receive a second vaccination owing to an unsolicited adverse event, mild cellulitis, that was associated with infection after an intravenous cannula placement to address an unrelated mild adverse event that occurred during the second week of follow-up.

Second vaccination was withheld because the participant was still recovering and receiving antibiotics. This participant remains in the trial. Figure 2. Figure 2.

Solicited Local and Systemic Adverse Events. The percentage of participants in each vaccine group (groups A, B, C, D, and E) with adverse events according to the maximum FDA toxicity grade (mild, moderate, or severe) during the 7 days after each vaccination is plotted for solicited local (Panel A) and systemic (Panel B) adverse events. There were no grade 4 (life-threatening) events. Participants who reported 0 events make up the remainder of the 100% calculation (not displayed).

Excluded were the three sentinel participants in groups C (5 μg + Matrix-M1, 5 μg + Matrix-M1) and D (25 μg + Matrix-M1, 25 μg + Matrix-M1), who received the trial vaccine in an open-label manner (see Table S7 for complete safety data on all participants).Overall reactogenicity was largely absent or mild, and second vaccinations were neither withheld nor delayed due to reactogenicity. After the first vaccination, local and systemic reactogenicity was absent or mild in the majority of participants (local. 100%, 96%, 89%, 84%, and 88% of participants in groups A, B, C, D, and E, respectively. Systemic.

91%, 92%, 96%, 68%, and 89%) who were unaware of treatment assignment (Figure 2 and Table S7). Two participants (2%), one each in groups D and E, had severe adverse events (headache, fatigue, and malaise). Two participants, one each in groups A and E, had reactogenicity events (fatigue, malaise, and tenderness) that extended 2 days after day 7. After the second vaccination, local and systemic reactogenicity were absent or mild in the majority of participants in the five groups (local.

100%, 100%, 65%, 67%, and 100% of participants, respectively. Systemic. 86%, 84%, 73%, 58%, and 96%) who were unaware of treatment assignment. One participant, in group D, had a severe local event (tenderness), and eight participants, one or two participants in each group, had severe systemic events.

The most common severe systemic events were joint pain and fatigue. Only one participant, in group D, had fever (temperature, 38.1°C) after the second vaccination, on day 1 only. No adverse event extended beyond 7 days after the second vaccination. Of note, the mean duration of reactogenicity events was 2 days or less for both the first vaccination and second vaccination periods.

Laboratory abnormalities of grade 2 or higher occurred in 13 participants (10%). 9 after the first vaccination and 4 after the second vaccination (Table S8). Abnormal laboratory values were not associated with any clinical manifestations and showed no worsening with repeat vaccination. Six participants (5%.

Five women and one man) had grade 2 or higher transient reductions in hemoglobin from baseline, with no evidence of hemolysis or microcytic anemia and with resolution within 7 to 21 days. Of the six, two had an absolute hemoglobin value (grade 2) that resolved or stabilized during the testing period. Four participants (3%), including one who had received placebo, had elevated liver enzymes that were noted after the first vaccination and resolved within 7 to 14 days (i.e., before the second vaccination). Vital signs remained stable immediately after vaccination and at all visits.

Unsolicited adverse events (Table S9) were predominantly mild in severity (in 71%, 91%, 83%, 90%, and 82% of participants in groups A, B, C, D, and E, respectively) and were similarly distributed across the groups receiving adjuvanted and unadjuvanted vaccine. There were no reports of severe adverse events. Immunogenicity Outcomes Figure 3. Figure 3.

SARS-CoV-2 Anti-Spike IgG and Neutralizing Antibody Responses. Shown are geometric mean anti-spike IgG enzyme-linked immunosorbent assay (ELISA) unit responses to recombinant severe acute respiratory syndrome coronavirus 2 (rSARS-CoV-2) protein antigens (Panel A) and wild-type SARS-CoV-2 microneutralization assay at an inhibitory concentration greater than 99% (MN IC>99%) titer responses (Panel B) at baseline (day 0), 3 weeks after the first vaccination (day 21), and 2 weeks after the second vaccination (day 35) for the placebo group (group A), the 25-μg unadjuvanted group (group B), the 5-μg and 25-μg adjuvanted groups (groups C and D, respectively), and the 25-μg adjuvanted and placebo group (group E). Diamonds and whisker endpoints represent geometric mean titer values and 95% confidence intervals, respectively. The Covid-19 human convalescent serum panel includes specimens from PCR-confirmed Covid-19 participants, obtained from Baylor College of Medicine (29 specimens for ELISA and 32 specimens for MN IC>99%), with geometric mean titer values according to Covid-19 severity.

The severity of Covid-19 is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to Covid-19 (with samples collected during contact and exposure assessment). Mean values (in black) for human convalescent serum are depicted next to (and of same color as) the category of Covid-19 patients, with the overall mean shown above the scatter plot (in black). For each trial vaccine group, the mean at day 35 is depicted above the scatterplot.ELISA anti-spike IgG geometric mean ELISA units (GMEUs) ranged from 105 to 116 at day 0. By day 21, responses had occurred for all adjuvanted regimens (1984, 2626, and 3317 GMEUs for groups C, D, and E, respectively), and geometric mean fold rises (GMFRs) exceeded those induced without adjuvant by a factor of at least 10 (Figure 3 and Table S10).

Within 7 days after the second vaccination with adjuvant (day 28. Groups C and D), GMEUs had further increased by a factor of 8 (to 15,319 and 20,429, respectively) over responses seen with the first vaccination, and within 14 days (day 35), responses had more than doubled yet again (to 63,160 and 47,521, respectively), achieving GMFRs that were approximately 100 times greater than those observed with rSARS-CoV-2 alone. A single vaccination with adjuvant achieved GMEU levels similar to those in asymptomatic (exposed) patients with Covid-19 (1661), and a second vaccination with adjuvant achieved GMEU levels that exceeded those in convalescent serum from symptomatic outpatients with Covid-19 (7420) by a factor of at least 6 and rose to levels similar to those in convalescent serum from patients hospitalized with Covid-19 (53,391). The responses in the two-dose 5-μg and 25-μg adjuvanted vaccine regimens were similar, a finding that highlights the role of adjuvant dose sparing.

Neutralizing antibodies were undetectable before vaccination and had patterns of response similar to those of anti-spike antibodies after vaccination with adjuvant (Figure 3 and Table S11). After the first vaccination (day 21), GMFRs were approximately 5 times greater with adjuvant (5.2, 6.3, and 5.9 for groups C, D, and E, respectively) than without adjuvant (1.1). By day 35, second vaccinations with adjuvant induced an increase more than 100 times greater (195 and 165 for groups C and D, respectively) than single vaccinations without adjuvant. When compared with convalescent serum, second vaccinations with adjuvant resulted in GMT levels approximately 4 times greater (3906 and 3305 for groups C and D, respectively) than those in symptomatic outpatients with Covid-19 (837) and approached the magnitude of levels observed in hospitalized patients with COVID-19 (7457).

At day 35, ELISA anti-spike IgG GMEUs and neutralizing antibodies induced by the two-dose 5-μg and 25-μg adjuvanted vaccine regimens were 4 to 6 times greater than the geometric mean convalescent serum measures (8344 and 983, respectively). Figure 4. Figure 4. Correlation of Anti-Spike IgG and Neutralizing Antibody Responses.

Shown are scatter plots of 100% wild-type neutralizing antibody responses and anti-spike IgG ELISA unit responses at 3 weeks after the first vaccination (day 21) and 2 weeks after the second vaccination (day 35) for the two-dose 25-μg unadjuvanted vaccine (group B. Panel A), the combined two-dose 5-μg and 25-μg adjuvanted vaccine (groups C and D, respectively. Panel B), and convalescent serum from patients with Covid-19 (Panel C). In Panel C, the severity of Covid-19 is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to Covid-19 (with samples collected during contact and exposure assessment).A strong correlation was observed between neutralizing antibody titers and anti-spike IgG GMEUs with adjuvanted vaccine at day 35 (correlation, 0.95) (Figure 4), a finding that was not observed with unadjuvanted vaccine (correlation, 0.76) but was similar to that of convalescent serum (correlation, 0.96).

Two-dose regimens of 5-μg and 25-μg rSARS-CoV-2 plus Matrix-M1 produced similar magnitudes of response, and every participant had seroconversion according to either assay measurement. Reverse cumulative-distribution curves for day 35 are presented in Figure S2. Figure 5. Figure 5.

RSARS-CoV-2 CD4+ T-cell Responses with or without Matrix-M1 Adjuvant. Frequencies of antigen-specific CD4+ T cells producing T helper 1 (Th1) cytokines interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), and interleukin-2 and for T helper 2 (Th2) cytokines interleukin-5 and interleukin-13 indicated cytokines from four participants each in the placebo (group A), 25-μg unadjuvanted (group B), 5-μg adjuvanted (group C), and 25-μg adjuvanted (group D) groups at baseline (day 0) and 1 week after the second vaccination (day 28) after stimulation with the recombinant spike protein. €œAny 2Th1” indicates CD4+ T cells that can produce two types of Th1 cytokines at the same time. €œAll 3 Th1” indicates CD4+ T cells that produce IFN-γ, TNF-α, and interleukin-2 simultaneously.

€œBoth Th2” indicates CD4+ T cells that can produce Th2 cytokines interleukin-5 and interleukin-13 at the same time.T-cell responses in 16 participants who were randomly selected from groups A through D, 4 participants per group, showed that adjuvanted regimens induced antigen-specific polyfunctional CD4+ T-cell responses that were reflected in IFN-γ, IL-2, and TNF-α production on spike protein stimulation. A strong bias toward this Th1 phenotype was noted. Th2 responses (as measured by IL-5 and IL-13 cytokines) were minimal (Figure 5).Start Preamble Centers for Medicare &. Medicaid Services (CMS), HHS.

Extension of timeline for publication of final rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule. As of August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021. Start Further Info Lisa O.

Wilson, (410) 786-8852. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory impact and burden of the physician self-referral law. The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care.

In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician. A new exception for donations of cybersecurity technology and related services. And amendments to the existing exception for electronic health records (EHR) items and services.

The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations. This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances.

In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the Spring 2020 Unified Agenda (June 30, 2020, www.reginfo.gov) that we would issue the final rule in August 2020. However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice extends the timeline for publication of the final rule until August 31, 2021.

Start Signature Dated. August 24, 2020. Wilma M. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-18867 Filed 8-26-20. 8:45 am]BILLING CODE 4120-01-PStart Preamble Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures.

This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020. Start Further Info Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. Telephone.

202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2.

It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020.

On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020).

On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure.

€œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S.

Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed. Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure.

Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations. Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID-19 pandemic, including. Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations.

Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks. The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates.

We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients.

Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate. For example, pharmacists already play a significant role in annual influenza vaccination. In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible.

Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements. The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE.

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP's standard immunization schedule. All States require children to be vaccinated against certain communicable diseases as a condition of school attendance.

These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified pandemic and epidemic products that “limit the harm such pandemic or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140COVID-19 as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII.

Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below.

All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr. 15, 2020) and 85 FR 35100 (June 8, 2020). 1.

Covered Persons, section V, delete in full and replace with. V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States.

In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency. (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule.

The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program.

All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2. Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII.

Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C. 247d-6d.

End Authority Start Signature Dated. August 19, 2020. Alex M. Azar II, Secretary of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20. 4:15 pm]BILLING CODE 4150-03-P.

Specificity of what do you need to buy tamiflu SARS-CoV-2 Antibody Assays Both assays measuring pan-Ig antibodies had low numbers of false positives among samples collected in 2017. There were 0 and 1 false positives for the two assays among 472 samples, results that compared favorably with those obtained with the single IgM what do you need to buy tamiflu anti-N and IgG anti-N assays (Table S3). Because of the low prevalence of SARS-CoV-2 infection in Iceland, we required positive results from both pan-Ig antibody assays for a sample to be considered seropositive (see Supplementary Methods in Supplementary Appendix 1).

None of the samples collected in early 2020 group were seropositive, which indicates that the virus had not what do you need to buy tamiflu spread widely in Iceland before February 2020. SARS-CoV-2 Antibodies among qPCR-Positive Persons Figure 2. Figure 2 what do you need to buy tamiflu.

Antibody Prevalence and Titers among qPCR-Positive Cases as a Function of Time since Diagnosis by qPCR. Shown are the percentages of what do you need to buy tamiflu samples positive for both pan-Ig antibody assays and the antibody titers. Red denotes the count or percentage of samples among persons during their hospitalization (249 samples from 48 persons), and blue denotes the count or percentage of samples among persons after they were declared recovered (1853 samples from 1215 persons).

Vertical bars denote 95% what do you need to buy tamiflu confidence intervals. The dashed lines indicated the thresholds for a test to be declared positive. OD denotes what do you need to buy tamiflu optical density, and RBD receptor binding domain.Table 1.

Table 1. Prevalence of what do you need to buy tamiflu SARS-CoV-2 Antibodies by Sample Collection as Measured by Two Pan-Ig Antibody Assays. Twenty-five days after diagnosis by qPCR, more than 90% of samples from recovered persons tested positive with what do you need to buy tamiflu both pan-Ig antibody assays, and the percentage of persons testing positive remained stable thereafter (Figure 2 and Fig.

S2). Hospitalized persons seroconverted more frequently and quickly after qPCR diagnosis what do you need to buy tamiflu than did nonhospitalized persons (Figure 2 and Fig. S3).

Of 1215 persons who had what do you need to buy tamiflu recovered (on the basis of results for the most recently obtained sample from persons for whom we had multiple samples), 1107 were seropositive (91.1%. 95% confidence interval [CI], 89.4 to 92.6) (Table 1 and Table S4). Since some diagnoses may have been made on the basis of false positive qPCR results, we determined that 91.1% represents what do you need to buy tamiflu the lower bound of sensitivity of the combined pan-Ig tests for the detection of SARS-CoV-2 antibodies among recovered persons.

Table 2. Table 2 what do you need to buy tamiflu. Results of Repeated Pan-Ig Antibody Tests among Recovered qPCR-Diagnosed Persons.

Among the 487 recovered what do you need to buy tamiflu persons with two or more samples, 19 (4%) had different pan-Ig antibody test results at different time points (Table 2 and Fig. S4). It is notable that of the 22 persons with an early sample that tested negative for both pan-Ig antibodies, 19 remained negative at the most recent test date (again, for both what do you need to buy tamiflu antibodies).

One person tested positive for both pan-Ig antibodies in the first test and negative for both in the most recent test. The longitudinal changes in antibody levels among recovered persons were consistent what do you need to buy tamiflu with the cross-sectional results (Fig. S5).

Antibody levels were higher in the last sample than in the first sample when the antibodies were measured with the two pan-Ig assays, slightly lower than in the first sample when measured with IgG anti-N and IgG anti-S1 assays, and substantially lower than in the first sample when measured with IgM anti-N and IgA anti-S1 assays. IgG anti-N, IgM anti-N, IgG anti-S1, and IgA anti-S1 antibody levels were correlated among the qPCR-positive persons (Figs. S5 and S6 and Table S5).

Antibody levels measured with both pan-Ig antibody assays increased over the first 2 months after qPCR diagnosis and remained at a plateau over the next 2 months of the study. IgM anti-N antibody levels increased rapidly soon after diagnosis and then fell rapidly and were generally not detected after 2 months. IgA anti-S1 antibodies decreased 1 month after diagnosis and remained detectable thereafter.

IgG anti-N and anti-S1 antibody levels increased during the first 6 weeks after diagnosis and then decreased slightly. SARS-CoV-2 Infection in Quarantine Table 3. Table 3.

SARS-CoV-2 Infection among Quarantined Persons According to Exposure Type and Presence of Symptoms. Of the 1797 qPCR-positive Icelanders, 1088 (61%) were in quarantine when SARS-CoV-2 infection was diagnosed by qPCR. We tested for antibodies among 4222 quarantined persons who had not tested qPCR-positive (they had received a negative result by qPCR or had simply not been tested).

Of those 4222 quarantined persons, 97 (2.3%. 95% CI, 1.9 to 2.8) were seropositive (Table 1). Those with household exposure were 5.2 (95% CI, 3.3 to 8.0) times more likely to be seropositive than those with other types of exposure (Table 3).

Similarly, a positive result by qPCR for those with household exposure was 5.2 (95% CI, 4.5 to 6.1) times more likely than for those with other types of exposure. When these two sets of results (qPCR-positive and seropositive) were combined, we calculated that 26.6% of quarantined persons with household exposure and 5.0% of quarantined persons without household exposure were infected. Those who had symptoms during quarantine were 3.2 (95% CI, 1.7 to 6.2) times more likely to be seropositive and 18.2 times (95% CI, 14.8 to 22.4) more likely to test positive with qPCR than those without symptoms.

We also tested persons in two regions of Iceland affected by cluster outbreaks. In a SARS-CoV-2 cluster in Vestfirdir, 1.4% of residents were qPCR-positive and 10% of residents were quarantined. We found that none of the 326 persons outside quarantine who had not been tested by qPCR (or who tested negative) were seropositive.

In a cluster in Vestmannaeyjar, 2.3% of residents were qPCR-positive and 13% of residents were quarantined. Of the 447 quarantined persons who had not received a qPCR-positive result, 4 were seropositive (0.9%. 95% CI, 0.3 to 2.1).

Of the 663 outside quarantine in Vestmannaeyjar, 3 were seropositive (0.5%. 95% CI, 0.1 to 0.2%). SARS-CoV-2 Seroprevalence in Iceland None of the serum samples collected from 470 healthy Icelanders between February 18 and March 9, 2020, tested positive for both pan-Ig antibodies, although four were positive for the pan-Ig anti-N assay (0.9%), a finding that suggests that the virus had not spread widely in Iceland before March 9.

Of the 18,609 persons tested for SARS-CoV-2 antibodies through contact with the Icelandic health care system for reasons other than Covid-19, 39 were positive for both pan-Ig antibody assays (estimated seroprevalence by weighting the sample on the basis of residence, sex, and 10-year age category, 0.3%. 95% CI, 0.2 to 0.4). There were regional differences in the percentages of qPCR-positive persons across Iceland that were roughly proportional to the percentage of people quarantined (Table S6).

However, after exclusion of the qPCR-positive and quarantined persons, the percentage of persons who tested positive for SARS-CoV-2 antibodies did not correlate with the percentage of those who tested positive by qPCR. The estimated seroprevalence in the random sample collection from Reykjavik (0.4%. 95% CI, 0.3 to 0.6) was similar to that in the Health Care group (0.3%.

95% CI, 0.2 to 0.4) (Table S6). We calculate that 0.5% of the residents of Iceland have tested positive with qPCR. The 2.3% with SARS-CoV-2 seroconversion among persons in quarantine extrapolates to 0.1% of Icelandic residents.

On the basis of this finding and the seroprevalence from the Health Care group, we estimate that 0.9% (95% CI, 0.8 to 0.9) of the population of Iceland has been infected by SARS-CoV-2. Approximately 56% of all SARS-CoV-2 infections were therefore diagnosed by qPCR, 14% occurred in quarantine without having been diagnosed with qPCR, and the remaining 30% of infections occurred outside quarantine and were not detected by qPCR. Deaths from Covid-19 in Iceland In Iceland, 10 deaths have been attributed to Covid-19, which corresponds to 3 deaths per 100,000 nationwide.

Among the qPCR-positive cases, 0.6% (95% CI, 0.3 to 1.0) were fatal. Using the 0.9% prevalence of SARS-CoV-2 infection in Iceland as the denominator, however, we calculate an infection fatality risk of 0.3% (95% CI, 0.2 to 0.6). Stratified by age, the infection fatality risk was substantially lower in those 70 years old or younger (0.1%.

95% CI, 0.0 to 0.3) than in those over 70 years of age (4.4%. 95% CI, 1.9 to 8.4) (Table S7). Age, Sex, Clinical Characteristics, and Antibody Levels Table 4.

Table 4. Association of Existing Conditions and Covid-19 Severity with SARS-CoV-2 Antibody Levels among Recovered Persons. SARS-CoV-2 antibody levels were higher in older people and in those who were hospitalized (Table 4, and Table S8 [described in Supplementary Appendix 1 and available in Supplementary Appendix 2]).

Pan-Ig anti–S1-RBD and IgA anti-S1 levels were lower in female persons. Of the preexisting conditions, and after adjustment for multiple testing, we found that body-mass index, smoking status, and use of antiinflammatory medication were associated with SARS-CoV-2 antibody levels. Body-mass index correlated positively with antibody levels.

Smokers and users of antiinflammatory medication had lower antibody levels. With respect to clinical characteristics, antibody levels were most strongly associated with hospitalization and clinical severity, followed by clinical symptoms such as fever, maximum temperature reading, cough, and loss of appetite. Severity of these individual symptoms, with the exception of loss of energy, was associated with higher antibody levels.To the Editor.

Rapid and accurate diagnostic tests are essential for controlling the ongoing Covid-19 pandemic. Although the current standard involves testing of nasopharyngeal swab specimens by quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) to detect SARS-CoV-2, saliva specimens may be an alternative diagnostic sample.1-4 Rigorous evaluation is needed to determine how saliva specimens compare with nasopharyngeal swab specimens with respect to sensitivity in detection of SARS-CoV-2 during the course of infection. A total of 70 inpatients with Covid-19 provided written informed consent to participate in our study (see the Methods section in Supplementary Appendix 1, available with the full text of this letter at NEJM.org).

After Covid-19 was confirmed with a positive nasopharyngeal swab specimen at hospital admission, we obtained additional samples from the patients during hospitalization. We tested saliva specimens collected by the patients themselves and nasopharyngeal swabs collected from the patients at the same time point by health care workers. Figure 1.

Figure 1. SARS-CoV-2 RNA Titers in Saliva Specimens and Nasopharyngeal Swab Specimens. Samples were obtained from 70 hospital inpatients who had a diagnosis of Covid-19.

Panel A shows SARS-CoV-2 RNA titers in the first available nasopharyngeal and saliva samples. The lines indicate samples from the same patient. Results were compared with the use of a Wilcoxon signed-rank test (P<0.001).

Panel B shows percentages of positivity for SARS-CoV-2 in tests of the first matched nasopharyngeal and saliva samples at 1 to 5 days, 6 to 10 days, and 11 or more days (maximum, 53 days) after the diagnosis of Covid-19. Panel C shows longitudinal SARS-CoV-2 RNA copies per milliliter in 97 saliva samples, according to days since symptom onset. Each circle represents a separate sample.

Dashed lines indicate additional samples from the same patient. The red line indicates a negative saliva sample that was followed by a positive sample at the next collection of a specimen. Panel D shows longitudinal SARS-CoV-2 RNA copies per milliliter in 97 nasopharyngeal swab specimens, according to days since symptom onset.

The red lines indicate negative nasopharyngeal swab specimens there were followed by a positive swab at the next collection of a specimen. The gray area in Panels C and D indicates samples that were below the lower limit of detection of 5610 virus RNA copies per milliliter of sample, which is at cycle threshold 38 of our quantitative reverse-transcriptase polymerase chain reaction assay targeting the SARS-CoV-2 N1 sequence recommended by the Centers for Disease Control and Prevention. To analyze these data, we used a linear mixed-effects regression model (see Supplementary Appendix 1) that accounts for the correlation between samples collected from the same person at a single time point (i.e., multivariate response) and the correlation between samples collected across time from the same patient (i.e., repeated measures).

All the data used to generate this figure, including the raw cycle thresholds, are provided in Supplementary Data 1 in Supplementary Appendix 2.Using primer sequences from the Centers for Disease Control and Prevention, we detected more SARS-CoV-2 RNA copies in the saliva specimens (mean log copies per milliliter, 5.58. 95% confidence interval [CI], 5.09 to 6.07) than in the nasopharyngeal swab specimens (mean log copies per milliliter, 4.93. 95% CI, 4.53 to 5.33) (Figure 1A, and Fig.

S1 in Supplementary Appendix 1). In addition, a higher percentage of saliva samples than nasopharyngeal swab samples were positive up to 10 days after the Covid-19 diagnosis (Figure 1B). At 1 to 5 days after diagnosis, 81% (95% CI, 71 to 96) of the saliva samples were positive, as compared with 71% (95% CI, 67 to 94) of the nasopharyngeal swab specimens.

These findings suggest that saliva specimens and nasopharyngeal swab specimens have at least similar sensitivity in the detection of SARS-CoV-2 during the course of hospitalization. Because the results of testing of nasopharyngeal swab specimens to detect SARS-CoV-2 may vary with repeated sampling in individual patients,5 we evaluated viral detection in matched samples over time. The level of SARS-CoV-2 RNA decreased after symptom onset in both saliva specimens (estimated slope, −0.11.

95% credible interval, −0.15 to −0.06) (Figure 1C) and nasopharyngeal swab specimens (estimated slope, −0.09. 95% credible interval, −0.13 to −0.05) (Figure 1D). In three instances, a negative nasopharyngeal swab specimen was followed by a positive swab at the next collection of a specimen (Figure 1D).

This phenomenon occurred only once with the saliva specimens (Figure 1C). During the clinical course, we observed less variation in levels of SARS-CoV-2 RNA in the saliva specimens (standard deviation, 0.98 virus RNA copies per milliliter. 95% credible interval, 0.08 to 1.98) than in the nasopharyngeal swab specimens (standard deviation, 2.01 virus RNA copies per milliliter.

95% credible interval, 1.29 to 2.70) (see Supplementary Appendix 1). Recent studies have shown that SARS-CoV-2 can be detected in the saliva of asymptomatic persons and outpatients.1-3 We therefore screened 495 asymptomatic health care workers who provided written informed consent to participate in our prospective study, and we used RT-qPCR to test both saliva and nasopharyngeal samples obtained from these persons. We detected SARS-CoV-2 RNA in saliva specimens obtained from 13 persons who did not report any symptoms at or before the time of sample collection.

Of these 13 health care workers, 9 had collected matched nasopharyngeal swab specimens by themselves on the same day, and 7 of these specimens tested negative (Fig. S2). The diagnosis in the 13 health care workers with positive saliva specimens was later confirmed in diagnostic testing of additional nasopharyngeal samples by a CLIA (Clinical Laboratory Improvement Amendments of 1988)–certified laboratory.

Variation in nasopharyngeal sampling may be an explanation for false negative results, so monitoring an internal control for proper sample collection may provide an alternative evaluation technique. In specimens collected from inpatients by health care workers, we found greater variation in human RNase P cycle threshold (Ct) values in nasopharyngeal swab specimens (standard deviation, 2.89 Ct. 95% CI, 26.53 to 27.69) than in saliva specimens (standard deviation, 2.49 Ct.

95% CI, 23.35 to 24.35). When health care workers collected their own specimens, we also found greater variation in RNase P Ct values in nasopharyngeal swab specimens (standard deviation, 2.26 Ct. 95% CI, 28.39 to 28.56) than in saliva specimens (standard deviation , 1.65 Ct.

95% CI, 24.14 to 24.26) (Fig. S3). Collection of saliva samples by patients themselves negates the need for direct interaction between health care workers and patients.

This interaction is a source of major testing bottlenecks and presents a risk of nosocomial infection. Collection of saliva samples by patients themselves also alleviates demands for supplies of swabs and personal protective equipment. Given the growing need for testing, our findings provide support for the potential of saliva specimens in the diagnosis of SARS-CoV-2 infection.

Anne L. Wyllie, Ph.D.Yale School of Public Health, New Haven, CT [email protected]John Fournier, M.D.Yale School of Medicine, New Haven, CTArnau Casanovas-Massana, Ph.D.Yale School of Public Health, New Haven, CTMelissa Campbell, M.D.Maria Tokuyama, Ph.D.Pavithra Vijayakumar, B.A.Yale School of Medicine, New Haven, CTJoshua L. Warren, Ph.D.Yale School of Public Health, New Haven, CTBertie Geng, M.D.Yale School of Medicine, New Haven, CTM.

Catherine Muenker, M.S.Adam J. Moore, M.P.H.Chantal B.F. Vogels, Ph.D.Mary E.

Petrone, B.S.Isabel M. Ott, B.S.Yale School of Public Health, New Haven, CTPeiwen Lu, Ph.D.Arvind Venkataraman, B.S.Alice Lu-Culligan, B.S.Jonathan Klein, B.S.Yale School of Medicine, New Haven, CTRebecca Earnest, M.P.H.Yale School of Public Health, New Haven, CTMichael Simonov, M.D.Rupak Datta, M.D., Ph.D.Ryan Handoko, M.D.Nida Naushad, B.S.Lorenzo R. Sewanan, M.Phil.Jordan Valdez, B.S.Yale School of Medicine, New Haven, CTElizabeth B.

White, A.B.Sarah Lapidus, M.S.Chaney C. Kalinich, M.P.H.Yale School of Public Health, New Haven, CTXiaodong Jiang, M.D., Ph.D.Daniel J. Kim, A.B.Eriko Kudo, Ph.D.Melissa Linehan, M.S.Tianyang Mao, B.S.Miyu Moriyama, Ph.D.Ji E.

Oh, M.D., Ph.D.Annsea Park, B.A.Julio Silva, B.S.Eric Song, M.S.Takehiro Takahashi, M.D., Ph.D.Manabu Taura, Ph.D.Orr-El Weizman, B.A.Patrick Wong, M.S.Yexin Yang, B.S.Santos Bermejo, B.S.Yale School of Medicine, New Haven, CTCamila D. Odio, M.D.Yale New Haven Health, New Haven, CTSaad B. Omer, M.B., B.S., Ph.D.Yale Institute for Global Health, New Haven, CTCharles S.

Dela Cruz, M.D., Ph.D.Shelli Farhadian, M.D., Ph.D.Richard A. Martinello, M.D.Akiko Iwasaki, Ph.D.Yale School of Medicine, New Haven, CTNathan D. Grubaugh, Ph.D.Albert I.

Ko, M.D.Yale School of Public Health, New Haven, CT [email protected], [email protected] Supported by the Huffman Family Donor Advised Fund, a Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University, the Yale Institute for Global Health, the Yale School of Medicine, a grant (U19 AI08992, to Dr. Ko) from the National Institute of Allergy and Infectious Diseases, the Beatrice Kleinberg Neuwirth Fund, and a grant (Rubicon 019.181EN.004, to Dr. Vogel) from the Dutch Research Council (NWO).

Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org. This letter was published on August 28, 2020, at NEJM.org. Drs.

Grubaugh and Ko contributed equally to this letter. 5 References1. Kojima N, Turner F, Slepnev V, et al.

Self-collected oral fluid and nasal swabs demonstrate comparable sensitivity to clinician collected nasopharyngeal swabs for Covid-19 detection. April 15, 2020 (https://www.medrxiv.org/content/10.1101/2020.04.11.20062372v1). Preprint.Google Scholar2.

Williams E, Bond K, Zhang B, Putland M, Williamson DA. Saliva as a non-invasive specimen for detection of SARS-CoV-2. J Clin Microbiol 2020;58(8):e00776-20-e00776-20.3.

Pasomsub E, Watcharananan SP, Boonyawat K, et al. Saliva sample as a non-invasive specimen for the diagnosis of coronavirus disease 2019. A cross-sectional study.

Clin Microbiol Infect 2020 May 15 (Epub ahead of print).4. Vogels CBF, Brackney D, Wang J, et al. SalivaDirect.

Simple and sensitive molecular diagnostic test for SARS-CoV-2 surveillance. August 4, 2020 (https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v1). Preprint.Google Scholar5.

Zou L, Ruan F, Huang M, et al. SARS-CoV-2 viral load in upper respiratory specimens of infected patients. N Engl J Med 2020;382:1177-1179.Trial Population Table 1.

Table 1. Demographic Characteristics of the Participants in the NVX-CoV2373 Trial at Enrollment. The trial was initiated on May 26, 2020.

134 participants underwent randomization between May 27 and June 6, 2020, including 3 participants who were to serve as backups for sentinel dosing and who immediately withdrew from the trial without being vaccinated (Fig. S1). Of the 131 participants who received injections, 23 received placebo (group A), 25 received 25-μg doses of rSARS-CoV-2 (group B), 29 received 5-μg doses of rSARS-CoV-2 plus Matrix-M1, including three sentinels (group C), 28 received 25-μg doses of rSARS-CoV-2 plus Matrix-M1, including three sentinels (group D), and 26 received a single 25-μg dose of rSARS-CoV-2 plus Matrix-M1 followed by a single dose of placebo (group E).

All 131 participants received their first vaccination on day 0, and all but 3 received their second vaccination at least 21 days later. Exceptions include 2 in the placebo group (group A) who withdrew consent (unrelated to any adverse event) and 1 in the 25-μg rSARS-CoV-2 + Matrix-M1 group (group D) who had an unsolicited adverse event (mild cellulitis. See below).

Demographic characteristics of the participants are presented in Table 1. Of note, missing data were infrequent. Safety Outcomes No serious adverse events or adverse events of special interest were reported, and vaccination pause rules were not implemented.

As noted above, one participant did not receive a second vaccination owing to an unsolicited adverse event, mild cellulitis, that was associated with infection after an intravenous cannula placement to address an unrelated mild adverse event that occurred during the second week of follow-up. Second vaccination was withheld because the participant was still recovering and receiving antibiotics. This participant remains in the trial.

Figure 2. Figure 2. Solicited Local and Systemic Adverse Events.

The percentage of participants in each vaccine group (groups A, B, C, D, and E) with adverse events according to the maximum FDA toxicity grade (mild, moderate, or severe) during the 7 days after each vaccination is plotted for solicited local (Panel A) and systemic (Panel B) adverse events. There were no grade 4 (life-threatening) events. Participants who reported 0 events make up the remainder of the 100% calculation (not displayed).

Excluded were the three sentinel participants in groups C (5 μg + Matrix-M1, 5 μg + Matrix-M1) and D (25 μg + Matrix-M1, 25 μg + Matrix-M1), who received the trial vaccine in an open-label manner (see Table S7 for complete safety data on all participants).Overall reactogenicity was largely absent or mild, and second vaccinations were neither withheld nor delayed due to reactogenicity. After the first vaccination, local and systemic reactogenicity was absent or mild in the majority of participants (local. 100%, 96%, 89%, 84%, and 88% of participants in groups A, B, C, D, and E, respectively.

Systemic. 91%, 92%, 96%, 68%, and 89%) who were unaware of treatment assignment (Figure 2 and Table S7). Two participants (2%), one each in groups D and E, had severe adverse events (headache, fatigue, and malaise).

Two participants, one each in groups A and E, had reactogenicity events (fatigue, malaise, and tenderness) that extended 2 days after day 7. After the second vaccination, local and systemic reactogenicity were absent or mild in the majority of participants in the five groups (local. 100%, 100%, 65%, 67%, and 100% of participants, respectively.

Systemic. 86%, 84%, 73%, 58%, and 96%) who were unaware of treatment assignment. One participant, in group D, had a severe local event (tenderness), and eight participants, one or two participants in each group, had severe systemic events.

The most common severe systemic events were joint pain and fatigue. Only one participant, in group D, had fever (temperature, 38.1°C) after the second vaccination, on day 1 only. No adverse event extended beyond 7 days after the second vaccination.

Of note, the mean duration of reactogenicity events was 2 days or less for both the first vaccination and second vaccination periods. Laboratory abnormalities of grade 2 or higher occurred in 13 participants (10%). 9 after the first vaccination and 4 after the second vaccination (Table S8).

Abnormal laboratory values were not associated with any clinical manifestations and showed no worsening with repeat vaccination. Six participants (5%. Five women and one man) had grade 2 or higher transient reductions in hemoglobin from baseline, with no evidence of hemolysis or microcytic anemia and with resolution within 7 to 21 days.

Of the six, two had an absolute hemoglobin value (grade 2) that resolved or stabilized during the testing period. Four participants (3%), including one who had received placebo, had elevated liver enzymes that were noted after the first vaccination and resolved within 7 to 14 days (i.e., before the second vaccination). Vital signs remained stable immediately after vaccination and at all visits.

Unsolicited adverse events (Table S9) were predominantly mild in severity (in 71%, 91%, 83%, 90%, and 82% of participants in groups A, B, C, D, and E, respectively) and were similarly distributed across the groups receiving adjuvanted and unadjuvanted vaccine. There were no reports of severe adverse events. Immunogenicity Outcomes Figure 3.

Figure 3. SARS-CoV-2 Anti-Spike IgG and Neutralizing Antibody Responses. Shown are geometric mean anti-spike IgG enzyme-linked immunosorbent assay (ELISA) unit responses to recombinant severe acute respiratory syndrome coronavirus 2 (rSARS-CoV-2) protein antigens (Panel A) and wild-type SARS-CoV-2 microneutralization assay at an inhibitory concentration greater than 99% (MN IC>99%) titer responses (Panel B) at baseline (day 0), 3 weeks after the first vaccination (day 21), and 2 weeks after the second vaccination (day 35) for the placebo group (group A), the 25-μg unadjuvanted group (group B), the 5-μg and 25-μg adjuvanted groups (groups C and D, respectively), and the 25-μg adjuvanted and placebo group (group E).

Diamonds and whisker endpoints represent geometric mean titer values and 95% confidence intervals, respectively. The Covid-19 human convalescent serum panel includes specimens from PCR-confirmed Covid-19 participants, obtained from Baylor College of Medicine (29 specimens for ELISA and 32 specimens for MN IC>99%), with geometric mean titer values according to Covid-19 severity. The severity of Covid-19 is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to Covid-19 (with samples collected during contact and exposure assessment).

Mean values (in black) for human convalescent serum are depicted next to (and of same color as) the category of Covid-19 patients, with the overall mean shown above the scatter plot (in black). For each trial vaccine group, the mean at day 35 is depicted above the scatterplot.ELISA anti-spike IgG geometric mean ELISA units (GMEUs) ranged from 105 to 116 at day 0. By day 21, responses had occurred for all adjuvanted regimens (1984, 2626, and 3317 GMEUs for groups C, D, and E, respectively), and geometric mean fold rises (GMFRs) exceeded those induced without adjuvant by a factor of at least 10 (Figure 3 and Table S10).

Within 7 days after the second vaccination with adjuvant (day 28. Groups C and D), GMEUs had further increased by a factor of 8 (to 15,319 and 20,429, respectively) over responses seen with the first vaccination, and within 14 days (day 35), responses had more than doubled yet again (to 63,160 and 47,521, respectively), achieving GMFRs that were approximately 100 times greater than those observed with rSARS-CoV-2 alone. A single vaccination with adjuvant achieved GMEU levels similar to those in asymptomatic (exposed) patients with Covid-19 (1661), and a second vaccination with adjuvant achieved GMEU levels that exceeded those in convalescent serum from symptomatic outpatients with Covid-19 (7420) by a factor of at least 6 and rose to levels similar to those in convalescent serum from patients hospitalized with Covid-19 (53,391).

The responses in the two-dose 5-μg and 25-μg adjuvanted vaccine regimens were similar, a finding that highlights the role of adjuvant dose sparing. Neutralizing antibodies were undetectable before vaccination and had patterns of response similar to those of anti-spike antibodies after vaccination with adjuvant (Figure 3 and Table S11). After the first vaccination (day 21), GMFRs were approximately 5 times greater with adjuvant (5.2, 6.3, and 5.9 for groups C, D, and E, respectively) than without adjuvant (1.1).

By day 35, second vaccinations with adjuvant induced an increase more than 100 times greater (195 and 165 for groups C and D, respectively) than single vaccinations without adjuvant. When compared with convalescent serum, second vaccinations with adjuvant resulted in GMT levels approximately 4 times greater (3906 and 3305 for groups C and D, respectively) than those in symptomatic outpatients with Covid-19 (837) and approached the magnitude of levels observed in hospitalized patients with COVID-19 (7457). At day 35, ELISA anti-spike IgG GMEUs and neutralizing antibodies induced by the two-dose 5-μg and 25-μg adjuvanted vaccine regimens were 4 to 6 times greater than the geometric mean convalescent serum measures (8344 and 983, respectively).

Figure 4. Figure 4. Correlation of Anti-Spike IgG and Neutralizing Antibody Responses.

Shown are scatter plots of 100% wild-type neutralizing antibody responses and anti-spike IgG ELISA unit responses at 3 weeks after the first vaccination (day 21) and 2 weeks after the second vaccination (day 35) for the two-dose 25-μg unadjuvanted vaccine (group B. Panel A), the combined two-dose 5-μg and 25-μg adjuvanted vaccine (groups C and D, respectively. Panel B), and convalescent serum from patients with Covid-19 (Panel C).

In Panel C, the severity of Covid-19 is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to Covid-19 (with samples collected during contact and exposure assessment).A strong correlation was observed between neutralizing antibody titers and anti-spike IgG GMEUs with adjuvanted vaccine at day 35 (correlation, 0.95) (Figure 4), a finding that was not observed with unadjuvanted vaccine (correlation, 0.76) but was similar to that of convalescent serum (correlation, 0.96). Two-dose regimens of 5-μg and 25-μg rSARS-CoV-2 plus Matrix-M1 produced similar magnitudes of response, and every participant had seroconversion according to either assay measurement. Reverse cumulative-distribution curves for day 35 are presented in Figure S2.

Figure 5. Figure 5. RSARS-CoV-2 CD4+ T-cell Responses with or without Matrix-M1 Adjuvant.

Frequencies of antigen-specific CD4+ T cells producing T helper 1 (Th1) cytokines interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), and interleukin-2 and for T helper 2 (Th2) cytokines interleukin-5 and interleukin-13 indicated cytokines from four participants each in the placebo (group A), 25-μg unadjuvanted (group B), 5-μg adjuvanted (group C), and 25-μg adjuvanted (group D) groups at baseline (day 0) and 1 week after the second vaccination (day 28) after stimulation with the recombinant spike protein. €œAny 2Th1” indicates CD4+ T cells that can produce two types of Th1 cytokines at the same time. €œAll 3 Th1” indicates CD4+ T cells that produce IFN-γ, TNF-α, and interleukin-2 simultaneously.

€œBoth Th2” indicates CD4+ T cells that can produce Th2 cytokines interleukin-5 and interleukin-13 at the same time.T-cell responses in 16 participants who were randomly selected from groups A through D, 4 participants per group, showed that adjuvanted regimens induced antigen-specific polyfunctional CD4+ T-cell responses that were reflected in IFN-γ, IL-2, and TNF-α production on spike protein stimulation. A strong bias toward this Th1 phenotype was noted. Th2 responses (as measured by IL-5 and IL-13 cytokines) were minimal (Figure 5).Start Preamble Centers for Medicare &.

Medicaid Services (CMS), HHS. Extension of timeline for publication of final rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule.

As of August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021. Start Further Info Lisa O. Wilson, (410) 786-8852.

End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory impact and burden of the physician self-referral law. The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care.

In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician. A new exception for donations of cybersecurity technology and related services.

And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations. This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule.

Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances. In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation.

We announced in the Spring 2020 Unified Agenda (June 30, 2020, www.reginfo.gov) that we would issue the final rule in August 2020. However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice extends the timeline for publication of the final rule until August 31, 2021.

Start Signature Dated. August 24, 2020. Wilma M.

Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-18867 Filed 8-26-20.

8:45 am]BILLING CODE 4120-01-PStart Preamble Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures. This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020.

Start Further Info Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. Telephone.

202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant.

The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C.

247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act.

On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020.

On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr.

15, 2020). On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.

Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S.

Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed. Most practices had reduced office hours for in-person visits.

When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations.

Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID-19 pandemic, including. Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms.

Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks. The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates.

We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience.

What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate. For example, pharmacists already play a significant role in annual influenza vaccination.

In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible. Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements.

The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE.

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP's standard immunization schedule.

All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified pandemic and epidemic products that “limit the harm such pandemic or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140COVID-19 as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq.

Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII.

Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19.

Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr.

15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with.

V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States.

In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency. (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act.

(c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met.

The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE).

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.

The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures.

2. Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII.

Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C.

247d-6d. End Authority Start Signature Dated. August 19, 2020.

Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc.

2020-18542 Filed 8-20-20. 4:15 pm]BILLING CODE 4150-03-P.

How long do tamiflu side effects last

Aug. 29, 2020 -- Chadwick Boseman, the star of the 2018 Marvel Studios megahit Black Panther, died of colon cancer Friday. He was 43. Boseman, who was diagnosed 4 years ago, had kept his condition a secret.

He filmed his recent movies ''during and between countless surgeries and chemotherapy," according to a statement issued on his Twitter account. When the actor was diagnosed in 2016, the cancer was at stage III -- meaning it had already grown through the colon wall -- but then progressed to the more lethal stage IV, meaning it had spread beyond his colon. Messages of condolences and the hashtag #Wakandaforever, referring to the fictional African nation in the Black Panther film, flooded social media Friday evening. Oprah tweeted.

"What a gentle gifted SOUL. Showing us all that Greatness in between surgeries and chemo. The courage, the strength, the Power it takes to do that. This is what Dignity looks like.

" Marvel Studios tweeted. "Your legacy will live on forever." Boseman was also known for his role as Jackie Robinson in the movie 42. Coincidentally, Friday was Major League Baseball's Jackie Robinson Day, where every player on every team wears Robinson's number 42 on their jerseys. Boseman's other starring roles include portraying James Brown in Get on Up and U.S.

Supreme Court Justice Thurgood Marshall in Marshall. But his role as King T'Challa in Black Panther, the super hero protagonist, made him an icon and an inspiration. About Colon Cancer Boseman's death reflects a troubling recent trend, says Mark Hanna, MD, a colorectal surgeon at City of Hope, a comprehensive cancer center near Los Angeles. "We have noticed an increasing incidence of colorectal cancer in young adults," says Hanna, who did not treat Boseman.

"I've seen patients as young as their early 20s." About 104,000 cases of colon cancer will be diagnosed this year, according to American Cancer Society estimates, and another 43,000 cases of rectal cancer will be diagnosed. About 12% of those, or 18,000 cases, will be in people under age 50. As the rates have declined in older adults due to screening, rates in young adults have steadily risen. Younger patients are often diagnosed at a later stage than older adults, Hanna says, because patients and even their doctors don't think about the possibility of colon cancer.

Because it is considered a cancer affecting older adults, many younger people may brush off the symptoms or delay getting medical attention, Hanna says. In a survey of 885 colorectal cancer patients conducted by Colorectal Cancer Alliance earlier this year, 75% said they visited two or more doctors before getting their diagnosis, and 11% went to 10 or more before finding out. If found early, colon cancer is curable, Hanna says. About 50% of those with colon cancer will be diagnosed at stage I or II, which is considered localized disease, he says.

"The majority have a very good prognosis." The 5-year survival rate is about 90% for both stage I and II. But when it progresses to stage III, the cancer has begun to grow into surrounding tissues and the lymph nodes, Hanna says, and the survival rate for 5 years drops to 75%. About 25% of patients are diagnosed at stage III, he says. If the diagnosis is made at stage IV, the 5-year survival rate drops to about 10% or 15%, he says.

Experts have been trying to figure out why more young adults are getting colon cancer and why some do so poorly. "Traditionally we thought that patients who are older would have a worse outlook," Hanna says, partly because they tend to have other medical conditions too. Some experts say that younger patients might have more ''genetically aggressive disease," Hanna says. "Our understanding of colorectal cancer is becoming more nuanced, and we know that not all forms are the same." For instance, he says, testing is done for specific genetic mutations that have been tied to colon cancer.

"It's not just about finding the mutations, but finding the drug that targets [that form] best." Paying Attention to Red Flags "If you have any of what we call the red flag signs, do not ignore your symptoms no matter what your age is," Hanna says. Those are. In 2018, the American Cancer Society changed its guidelines for screening, recommending those at average risk start at age 45, not 50. The screening can be stool-based testing, such as a fecal occult blood test, or visual, such as a colonoscopy.

Hanna says he orders a colonoscopy if the symptoms suggest colon cancer, regardless of a patient's age. Family history of colorectal cancer is a risk factor, as are being obese or overweight, being sedentary, and eating lots of red meat. Sources Mark Hanna, MD, colorectal surgeon and assistant clinical professor of surgery, City of Hope, Los Angeles. American Cancer Society.

"Key Statistics for Colorectal Cancer." Twitter statement. Chadwick Boseman. American Cancer Society. "Colorectal Cancer Risk Factors." American Cancer Society.

'"Colorectal Cancer Rates Rise in Younger Adults." American Society of Clinical Oncology annual meeting, May 29-31, 2020. American Cancer Society "Survival Rates for Colorectal Cancer." American Cancer Society. "Colorectal Cancer Facts &. Figures.

2017-2019." © 2020 WebMD, LLC. All rights reserved.FRIDAY, Aug. 28, 2020 (HealthDay News) -- As many as 20% of Americans don't believe in vaccines, a new study finds. Misinformed vaccine beliefs drive opposition to public vaccine policies even more than politics, education, religion or other factors, researchers say.

The findings are based on a survey of nearly 2,000 U.S. Adults done in 2019, during the largest measles outbreak in 25 years. The researchers, from the Annenberg Public Policy Center (APPC) of the University of Pennsylvania, found that negative misperceptions about vaccinations. reduced the likelihood of supporting mandatory childhood vaccines by 70%, reduced the likelihood of opposing religious exemptions by 66%, reduced the likelihood of opposing personal belief exemptions by 79%.

"There are real implications here for a vaccine for COVID-19," lead author Dominik Stecula said in an APPC news release. He conducted the research while at APPC and is now an assistant professor of political science at Colorado State University. "The negative vaccine beliefs we examined aren't limited only to the measles, mumps and rubella [MMR] vaccine, but are general attitudes about vaccination." Stecula called for an education campaign by public health professionals and journalists, among others, to preemptively correct misinformation and prepare the public to accept a COVID-19 vaccine. Overall, there was strong support for vaccination policies.

72% strongly or somewhat supported mandatory childhood vaccination, 60% strongly or somewhat opposed religious exemptions, 66% strongly or somewhat opposed vaccine exemptions based on personal beliefs. "On the one hand, these are big majorities. Well above 50% of Americans support mandatory childhood vaccinations and oppose religious and personal belief exemptions to vaccination," said co-author Ozan Kuru, a former APPC researcher, now an assistant professor of communications at the National University of Singapore. "Still, we need a stronger consensus in the public to bolster pro-vaccine attitudes and legislation and thus achieve community immunity," he added in the release.

A previous study from the 2018-2019 measles outbreak found that people who rely on social media were more likely to be misinformed about vaccines. And a more recent one found that people who got information from social media or conservative news outlets at the start of the COVID-19 pandemic were more likely to be misinformed about how to prevent infection and hold conspiracy theories about it. With the coronavirus pandemic still raging, the number of Americans needed to be vaccinated to achieve community-wide immunity is not known, the researchers said. The findings were recently published online in the American Journal of Public Health.By Robert Preidt HealthDay Reporter FRIDAY, Aug.

28, 2020 (HealthDay News) -- Breastfeeding mothers are unlikely to transmit the new coronavirus to their babies via their milk, researchers say. No cases of an infant contracting COVID-19 from breast milk have been documented, but questions about the potential risk remain. Researchers examined 64 samples of breast milk collected from 18 women across the United States who were infected with the new coronavirus (SARS-CoV-2) that causes COVID-19. One sample tested positive for coronavirus RNA, but follow-up tests showed that the virus couldn't replicate and therefore, couldn't infect the breastfed infant, according to the study recently published online in the Journal of the American Medical Association.

"Detection of viral RNA does not equate to infection. It has to grow and multiply in order to be infectious and we did not find that in any of our samples," said study author Christina Chambers, a professor of pediatrics at the University of California, San Diego. She is also director of the Mommy's Milk Human Milk Research Biorepository. "Our findings suggest breast milk itself is not likely a source of infection for the infant," Chambers said in a UCSD news release.

To prevent transmission of the virus while breastfeeding, wearing a mask, hand-washing and sterilizing pumping equipment after each use are recommended. "We hope our results and future studies will give women the reassurance needed for them to breastfeed. Human milk provides invaluable benefits to mom and baby," said co-author Dr. Grace Aldrovandi, chief of the Division of Infectious Diseases at UCLA Mattel Children's Hospital in Los Angeles.

WebMD News from HealthDay Sources SOURCE. University of California, San Diego, news release, Aug. 19, 2020 Copyright © 2013-2020 HealthDay. All rights reserved.Nursing home staff will have to be tested regularly for COVID-19, and facilities that fail to do so will face fines, the Trump administration said Tuesday.

Even though they account for less than 1% of the nation's population, long-term care facilities account for 42% of COVID-19 deaths in the United States, the Associated Press reported. There have been more than 70,000 deaths in U.S. Nursing homes, according to the COVID Tracking Project. It's been months since the White House first urged governors to test all nursing home residents and staff, the AP reported.

WebMD News from HealthDay Copyright © 2013-2020 HealthDay. All rights reserved.August 28, 2020 -- Alcohol-based hand sanitizers that are packaged in containers that look like food items or drinks could cause injury or death if ingested, according to a new warning the FDA issued Thursday. Hand sanitizers are being packaged in beer cans, water bottles, juice bottles, vodka bottles and children’s food pouches, the FDA said. Some sanitizers also contain flavors, such as chocolate or raspberry, which could cause confusion.

€œI am increasingly concerned about hand sanitizer being packaged to appear to be consumable products, such as baby food or beverages,” Stephen Hahn, MD, the FDA commissioner, said in a statement. Accidentally drinking hand sanitizer — even a small amount — is potentially lethal to children. €œThese products could confuse consumers into accidentally ingesting a potentially deadly product,” he said. €œIt’s dangerous to add scents with food flavors to hand sanitizers which children could think smells like food, eat and get alcohol poisoning.” For example, the FDA received a report about a consumer who purchased a bottle that looked like drinkable water but was actually hand sanitizer.

In another report, a retailer informed the agency about a hand sanitizer product that was marketed in a pouch that looks like a children’s snack and had cartoons on it. Meanwhile, the FDA's warning list about dangerous hand sanitizers containing methanol continues to grow as some people are drinking the sanitizers to get an alcohol high. Others have believed a rumor, circulated online, that drinking the highly potent and toxic alcohol can disinfect the body, protecting them from COVID-19 infection. Earlier this month, the FDA also issued a warning about hand sanitizers contaminated with 1-propanol.

Ingesting 1-propanol can cause central nervous system depression, which can be fatal, the agency says. Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. One brand of sanitizer, Harmonic Nature S de RL de MI of Mexico, are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination. Poison control centers and state health departments have reported an increasing number of adverse events associated with hand sanitizer ingestion, including heart issues, nervous system problems, hospitalizations and deaths, according to the statement.

The FDA encouraged consumers and health care professionals to report issues to the MedWatch Adverse Event Reporting program. The agency is working with manufacturers to recall confusing and dangerous products and is encouraging retailers to remove some products from shelves. The FDA is also updating its list of hand sanitizer products that consumers should avoid. €œManufacturers should be vigilant about packaging and marketing their hand sanitizers in food or drink packages in an effort to mitigate any potential inadvertent use by consumers,” Hahn said..

Aug. 29, 2020 -- Chadwick Boseman, the star of the 2018 Marvel Studios megahit Black Panther, died of colon cancer Friday. He was 43. Boseman, who was diagnosed 4 years ago, had kept his condition a secret.

He filmed his recent movies ''during and between countless surgeries and chemotherapy," according to a statement issued on his Twitter account. When the actor was diagnosed in 2016, the cancer was at stage III -- meaning it had already grown through the colon wall -- but then progressed to the more lethal stage IV, meaning it had spread beyond his colon. Messages of condolences and the hashtag #Wakandaforever, referring to the fictional African nation in the Black Panther film, flooded social media Friday evening. Oprah tweeted.

"What a gentle gifted SOUL. Showing us all that Greatness in between surgeries and chemo. The courage, the strength, the Power it takes to do that. This is what Dignity looks like.

" Marvel Studios tweeted. "Your legacy will live on forever." Boseman was also known for his role as Jackie Robinson in the movie 42. Coincidentally, Friday was Major League Baseball's Jackie Robinson Day, where every player on every team wears Robinson's number 42 on their jerseys. Boseman's other starring roles include portraying James Brown in Get on Up and U.S.

Supreme Court Justice Thurgood Marshall in Marshall. But his role as King T'Challa in Black Panther, the super hero protagonist, made him an icon and an inspiration. About Colon Cancer Boseman's death reflects a troubling recent trend, says Mark Hanna, MD, a colorectal surgeon at City of Hope, a comprehensive cancer center near Los Angeles. "We have noticed an increasing incidence of colorectal cancer in young adults," says Hanna, who did not treat Boseman.

"I've seen patients as young as their early 20s." About 104,000 cases of colon cancer will be diagnosed this year, according to American Cancer Society estimates, and another 43,000 cases of rectal cancer will be diagnosed. About 12% of those, or 18,000 cases, will be in people under age 50. As the rates have declined in older adults due to screening, rates in young adults have steadily risen. Younger patients are often diagnosed at a later stage than older adults, Hanna says, because patients and even their doctors don't think about the possibility of colon cancer.

Because it is considered a cancer affecting older adults, many younger people may brush off the symptoms or delay getting medical attention, Hanna says. In a survey of 885 colorectal cancer patients conducted by Colorectal Cancer Alliance earlier this year, 75% said they visited two or more doctors before getting their diagnosis, and 11% went to 10 or more before finding out. If found early, colon cancer is curable, Hanna says. About 50% of those with colon cancer will be diagnosed at stage I or II, which is considered localized disease, he says.

"The majority have a very good prognosis." The 5-year survival rate is about 90% for both stage I and II. But when it progresses to stage III, the cancer has begun to grow into surrounding tissues and the lymph nodes, Hanna says, and the survival rate for 5 years drops to 75%. About 25% of patients are diagnosed at stage III, he says. If the diagnosis is made at stage IV, the 5-year survival rate drops to about 10% or 15%, he says.

Experts have been trying to figure out why more young adults are getting colon cancer and why some do so poorly. "Traditionally we thought that patients who are older would have a worse outlook," Hanna says, partly because they tend to have other medical conditions too. Some experts say that younger patients might have more ''genetically aggressive disease," Hanna says. "Our understanding of colorectal cancer is becoming more nuanced, and we know that not all forms are the same." For instance, he says, testing is done for specific genetic mutations that have been tied to colon cancer.

"It's not just about finding the mutations, but finding the drug that targets [that form] best." Paying Attention to Red Flags "If you have any of what we call the red flag signs, do not ignore your symptoms no matter what your age is," Hanna says. Those are. In 2018, the American Cancer Society changed its guidelines for screening, recommending those at average risk start at age 45, not 50. The screening can be stool-based testing, such as a fecal occult blood test, or visual, such as a colonoscopy.

Hanna says he orders a colonoscopy if the symptoms suggest colon cancer, regardless of a patient's age. Family history of colorectal cancer is a risk factor, as are being obese or overweight, being sedentary, and eating lots of red meat. Sources Mark Hanna, MD, colorectal surgeon and assistant clinical professor of surgery, City of Hope, Los Angeles. American Cancer Society.

"Key Statistics for Colorectal Cancer." Twitter statement. Chadwick Boseman. American Cancer Society. "Colorectal Cancer Risk Factors." American Cancer Society.

'"Colorectal Cancer Rates Rise in Younger Adults." American Society of Clinical Oncology annual meeting, May 29-31, 2020. American Cancer Society "Survival Rates for Colorectal Cancer." American Cancer Society. "Colorectal Cancer Facts &. Figures.

2017-2019." © 2020 WebMD, LLC. All rights reserved.FRIDAY, Aug. 28, 2020 (HealthDay News) -- As many as 20% of Americans don't believe in vaccines, a new study finds. Misinformed vaccine beliefs drive opposition to public vaccine policies even more than politics, education, religion or other factors, researchers say.

The findings are based on a survey of nearly 2,000 U.S. Adults done in 2019, during the largest measles outbreak in 25 years. The researchers, from the Annenberg Public Policy Center (APPC) of the University of Pennsylvania, found that negative misperceptions about vaccinations. reduced the likelihood of supporting mandatory childhood vaccines by 70%, reduced the likelihood of opposing religious exemptions by 66%, reduced the likelihood of opposing personal belief exemptions by 79%.

"There are real implications here for a vaccine for COVID-19," lead author Dominik Stecula said in an APPC news release. He conducted the research while at APPC and is now an assistant professor of political science at Colorado State University. "The negative vaccine beliefs we examined aren't limited only to the measles, mumps and rubella [MMR] vaccine, but are general attitudes about vaccination." Stecula called for an education campaign by public health professionals and journalists, among others, to preemptively correct misinformation and prepare the public to accept a COVID-19 vaccine. Overall, there was strong support for vaccination policies.

72% strongly or somewhat supported mandatory childhood vaccination, 60% strongly or somewhat opposed religious exemptions, 66% strongly or somewhat opposed vaccine exemptions based on personal beliefs. "On the one hand, these are big majorities. Well above 50% of Americans support mandatory childhood vaccinations and oppose religious and personal belief exemptions to vaccination," said co-author Ozan Kuru, a former APPC researcher, now an assistant professor of communications at the National University of Singapore. "Still, we need a stronger consensus in the public to bolster pro-vaccine attitudes and legislation and thus achieve community immunity," he added in the release.

A previous study from the 2018-2019 measles outbreak found that people who rely on social media were more likely to be misinformed about vaccines. And a more recent one found that people who got information from social media or conservative news outlets at the start of the COVID-19 pandemic were more likely to be misinformed about how to prevent infection and hold conspiracy theories about it. With the coronavirus pandemic still raging, the number of Americans needed to be vaccinated to achieve community-wide immunity is not known, the researchers said. The findings were recently published online in the American Journal of Public Health.By Robert Preidt HealthDay Reporter FRIDAY, Aug.

28, 2020 (HealthDay News) -- Breastfeeding mothers are unlikely to transmit the new coronavirus to their babies via their milk, researchers say. No cases of an infant contracting COVID-19 from breast milk have been documented, but questions about the potential risk remain. Researchers examined 64 samples of breast milk collected from 18 women across the United States who were infected with the new coronavirus (SARS-CoV-2) that causes COVID-19. One sample tested positive for coronavirus RNA, but follow-up tests showed that the virus couldn't replicate and therefore, couldn't infect the breastfed infant, according to the study recently published online in the Journal of the American Medical Association.

"Detection of viral RNA does not equate to infection. It has to grow and multiply in order to be infectious and we did not find that in any of our samples," said study author Christina Chambers, a professor of pediatrics at the University of California, San Diego. She is also director of the Mommy's Milk Human Milk Research Biorepository. "Our findings suggest breast milk itself is not likely a source of infection for the infant," Chambers said in a UCSD news release.

To prevent transmission of the virus while breastfeeding, wearing a mask, hand-washing and sterilizing pumping equipment after each use are recommended. "We hope our results and future studies will give women the reassurance needed for them to breastfeed. Human milk provides invaluable benefits to mom and baby," said co-author Dr. Grace Aldrovandi, chief of the Division of Infectious Diseases at UCLA Mattel Children's Hospital in Los Angeles.

WebMD News from HealthDay Sources SOURCE. University of California, San Diego, news release, Aug. 19, 2020 Copyright © 2013-2020 HealthDay. All rights reserved.Nursing home staff will have to be tested regularly for COVID-19, and facilities that fail to do so will face fines, the Trump administration said Tuesday.

Even though they account for less than 1% of the nation's population, long-term care facilities account for 42% of COVID-19 deaths in the United States, the Associated Press reported. There have been more than 70,000 deaths in U.S. Nursing homes, according to the COVID Tracking Project. It's been months since the White House first urged governors to test all nursing home residents and staff, the AP reported.

WebMD News from HealthDay Copyright © 2013-2020 HealthDay. All rights reserved.August 28, 2020 -- Alcohol-based hand sanitizers that are packaged in containers that look like food items or drinks could cause injury or death if ingested, according to a new warning the FDA issued Thursday. Hand sanitizers are being packaged in beer cans, water bottles, juice bottles, vodka bottles and children’s food pouches, the FDA said. Some sanitizers also contain flavors, such as chocolate or raspberry, which could cause confusion.

€œI am increasingly concerned about hand sanitizer being packaged to appear to be consumable products, such as baby food or beverages,” Stephen Hahn, MD, the FDA commissioner, said in a statement. Accidentally drinking hand sanitizer — even a small amount — is potentially lethal to children. €œThese products could confuse consumers into accidentally ingesting a potentially deadly product,” he said. €œIt’s dangerous to add scents with food flavors to hand sanitizers which children could think smells like food, eat and get alcohol poisoning.” For example, the FDA received a report about a consumer who purchased a bottle that looked like drinkable water but was actually hand sanitizer.

In another report, a retailer informed the agency about a hand sanitizer product that was marketed in a pouch that looks like a children’s snack and had cartoons on it. Meanwhile, the FDA's warning list about dangerous hand sanitizers containing methanol continues to grow as some people are drinking the sanitizers to get an alcohol high. Others have believed a rumor, circulated online, that drinking the highly potent and toxic alcohol can disinfect the body, protecting them from COVID-19 infection. Earlier this month, the FDA also issued a warning about hand sanitizers contaminated with 1-propanol.

Ingesting 1-propanol can cause central nervous system depression, which can be fatal, the agency says. Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. One brand of sanitizer, Harmonic Nature S de RL de MI of Mexico, are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination. Poison control centers and state health departments have reported an increasing number of adverse events associated with hand sanitizer ingestion, including heart issues, nervous system problems, hospitalizations and deaths, according to the statement.

The FDA encouraged consumers and health care professionals to report issues to the MedWatch Adverse Event Reporting program. The agency is working with manufacturers to recall confusing and dangerous products and is encouraging retailers to remove some products from shelves. The FDA is also updating its list of hand sanitizer products that consumers should avoid. €œManufacturers should be vigilant about packaging and marketing their hand sanitizers in food or drink packages in an effort to mitigate any potential inadvertent use by consumers,” Hahn said..