Overnight Health Care – Presented by Emergent Biosolutions – Pfizer seeks antiviral pill license

Welcome to Tuesday’s Overnight Health Care, where we follow the latest policy and news initiatives affecting your health. Sign up here: thehill.com/newsletter-signup.

A study in contrasts: if you are in DC, the indoor mesh mandate being lifted from Monday. But if you live or work in nearby Montgomery County, Maryland, the mandate will be reinstated this weekend.

Pfizer requests the Food and Drug Administration for emergency use of its antiviral pill to combat COVID-19.

For The Hill We Are Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com). Write to us with tips and feedback, and follow us on Twitter: @ PeterSullivan4, @NateWeixel and @ JustineColeman8.

Let’s get started.

Pfizer asks FDA for COVID-19 pill approval

Pfizer on Tuesday requested emergency permission for its antiviral oral COVID-19 treatment after a study found the pills dramatically reduced the risk of hospitalization.

The pharmaceutical giant is asking the Food and Drug Administration (FDA) to give Paxlovid permission to treat mild to moderate COVID-19 in patients at higher risk of hospitalization and death.

Pfizer said earlier that their trials showed the pills reduced the risk of hospitalizations and deaths by 89 percent.

Importance: Pfizer CEO Albert Bourla said in a statement that oral antiviral treatments for COVID-19, including Paxlovid, could play a “critical role” in the pandemic by preventing deaths and hospitalizations.

“We are moving as quickly as possible in our efforts to get this potential treatment in the hands of patients, and we look forward to working with the US FDA on its review of our application with other regulatory agencies around the world. ” he said.

Pfizer’s request makes Paxlovid the second oral COVID-19 treatment that the FDA is considering for an emergency use permit. Merck and its partner Ridgeback Biotherapeutics submitted for approval of molnupiravir last month.

FDA approval is likely to help more people access a COVID-19 treatment that is available to take at home.

read more here.

AN ANNOUNCEMENT OF NEW BIOSOLUTIONS


Emergent has produced over 100 million Covid-19 vaccine dose equivalents. Today, these critically important doses are being sent around the world to help fight the pandemic. Get the latest news on Emergents Covid-19 answers.

IN OTHER PFIZER NEWS: ANTIVIRAL PILL MUST BE MADE IN POOR NATIONS

Pfizer announced on Tuesday that it allows its antiviral COVID-19 pill to be manufactured in poorer nations around the world in an effort to help arm them with tools to fight the pandemic.

Pfizer said the company, under an agreement with the UN-backed Medicines Patent Pool (MPP), will manufacture and supply the pill in 95 lower-income countries. The agreement covers about 53 percent of the world’s population.

The company will not receive royalties for sales in the low-income countries, and it will waive royalties for sales in all the other countries under the agreement, as long as the World Health Organization describes COVID-19 as a public emergency of international concern.

Under the agreement, MPP will receive a royalty-free license for the antiviral pill from Pfizer. This agreement will allow manufacturers to receive a sublicense and the formula for the drug.

The organization will then be able to sell the drug for use in the 95 countries under the agreement once the pill is allowed to be used in those locations.

“We must work to ensure that all people – no matter where they live or their circumstances – have access to these breakthroughs, and we are pleased to be able to work with MPP to further our commitment to equity,” said Pfizer’s CEO Albert Bourla.

read more here.

Unvaccinated increasingly lean GOP: analysis

The gap between the vaccinated and the unvaccinated is widening. Unvaccinated adults are more than three times as likely to lean on Republicans than Democrats, a Kaiser Family Foundation analysis found.

The analysis, released Tuesday, found that the 27 percent of people who say they are unvaccinated are “disproportionately” Republican or Republican, based on data from the nonprofit organization’s COVID-19 Vaccine Monitor in October.

60 percent of unvaccinated people identify as Republicans or Republicans, despite making up 41 percent of the adult population. Meanwhile, 17 percent of the unvaccinated population are Democrats or democratically oriented.

The differences between Democrats and Republicans were not always so sharp.

In April, when 43 percent of adults were unvaccinated, 42 percent identified themselves as Republican or Republican-oriented, compared to 36 percent who were or leaned toward Democracy.

The partisan gap has grown so much that it has become a better predictor of COVID-19 vaccination status than age, race, education and insurance status. According to Kaiser, bias is about twice as strong a prediction as any other demographic.

Those who are uninsured, younger, live in rural areas and have less education see ever lower vaccination rates, but bias is still the “strongest” indicator of vaccination status.

Reasons: By examining why this gap exists, the analysis found that unvaccinated Republicans are more likely to say that the news exaggerates the seriousness of the pandemic and that it is a personal choice to be vaccinated. More than half of the vaccinated Republicans said the threat of COVID was overestimated, but 9 out of 10 unvaccinated Republicans were of the same opinion.

read more here.

AN ANNOUNCEMENT OF NEW BIOSOLUTIONS


At Emergent, we develop, manufacture and deliver protection against threats to public health. Find out how we have improved and strengthened quality control and oversight practices in our manufacturing of bulk drug for vaccine in support of Covid-19 vaccine production.

TWO THIRD PARTIES IN NEW QUESTION SAY THAT COLLECTIONS WILL LIKE PRE-PANDEMI

Two-thirds of Americans say their Thanksgiving collections will look like pre-pandemic collections, a new Monmouth University poll found.

The survey showed that 63 percent of Americans will celebrate Thanksgiving with the same number of people as they did before the coronavirus pandemic, and 5 percent said there will be more people attending their Thanksgiving this year compared to times before the pandemic.

By 2020, only 46 percent of Americans said they would have a Thanksgiving with the same number or more people than previous years.

The rise in Thanksgiving celebrations comes as COVID-19 vaccinations have become widely available to most Americans.

The survey shows that 64 percent of the people who hold Thanksgiving in their homes will not ask guests if they have been vaccinated against the virus. Only 27 percent of hosts will require guests to be fully vaccinated.

“Break out that extra card table. Thanksgiving is back, at least for most people. However, some are still cautious and will hold a virtual gathering again this year,” said Patrick Murray, director of the Monmouth University Polling Institute.

read more here.

The bite is facing uphill on vaccine mandate

The legal battle over the Biden administration’s workplace vaccine mandate was transferred to a Cincinnati-based federal appeals court on Tuesday, where experts say the administration may soon face an uphill battle as it seeks to have the mandate reinstated.

The move came after a court panel in Washington DC randomly selected the 6th Circuit Court among the country’s 12 regional federal appellate courts, combining the various legal challenges brought across the country in a single lawsuit.

The process resembled a Powerball drawing: table tennis balls representing each court were drawn from a wooden drum.

The random draw took place after the New Orleans-based Fifth Circuit Court of Appeals Court temporarily blocked the workplace mandate, which requires companies with at least 100 employees to have their employees either receive the COVID-19 vaccine or submit regularly. testing and mask. wearing before January 4th.

The rule was issued by the Department of Labor’s Occupational Safety and Health Administration (OSHA). Federal law authorizes OSHA to issue a temporary emergency standard if it establishes that workers are exposed to a “serious hazard” that necessitates a rule. However, states and private companies claim that COVID-19 is not a “serious danger” specific to the workplace, saying the rule is an unlawful violation of federal power.

Although the Cincinnati-based Sixth Circuit Court of Appeals, where the case has been redeployed, is considered somewhat less conservative than the Fifth Circuit Court that rejected the mandate, Tuesday’s move was hardly a resounding victory for the administration, legal experts said.

read more here.

Virtual Event Announcement – The Hill’s Future of Healthcare Summit: Tackling Costs and Roads to Care – Wednesday, November 17 from 6 p.m. 13:00 ET

COVID-19 has provided extraordinary challenges for our nation’s society and the health systems that serve them. As we move from pandemic response to recovery, how do we address the social, economic, and environmental factors that affect health and general access? Join The Hill for this year’s final Future of Healthcare Summit. Dens. Bill CassidyBill Cassidy Note: Highly criticized Trump policy puts Biden in a vise Biden sends the wrong message about climate change, the US is a leader in reducing emissions Google to let minors request removal of images from search MORE, MD (R-La.), Rep. Tony C├írdenas (D-Calif.), Andy Slavitt, AMA Former President Dr. Patrice Harris Join an exciting line-up for a discussion on promoting access, striving for equality in health and resetting the care paradigm. RSVP today.

WHAT WE READ

  • The Biden administration will announce the purchase of 10 million courses of Pfizer anti-covid pill (Washington Post)
  • Why healthcare professionals keep up in droves (Atlantic Ocean)
  • The Biden administration is planning an upcoming booster expansion for all adults (Axios)
  • The recording of flu shots is now biased. It used to not be (CNN)

STATE BY STATE

OP-EDS IN THE SLOPE

When federal guidance increases the confusion, it’s time for public input

That was it for today, thank you for reading along. Check out The Hill’s health care page for the latest news and coverage. See you wednesday.

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