Overnight Health Care — Presented by Emergent Biosolutions — Pfizer seeks authorization for antiviral pill

Welcome to Tuesday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here: digital-staging.thehill.com/newsletter-signup.

A study in contrasts: if you’re in DC, the indoor mask mandate is being lifted as of Monday. But if you live or work in neighboring Montgomery County in Maryland, the mandate is being reimposed this weekend. 

Pfizer is asking the Food and Drug Administration for emergency use authorization of its antiviral pill for combatting COVID-19. 

For The Hill, we’re Peter Sullivan (psullivan@digital-staging.thehill.com), Nathaniel Weixel (nweixel@digital-staging.thehill.com) and Justine Coleman (jcoleman@digital-staging.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 authorization 

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

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

Pfizer previously said its trial found the pills reduced the risk of hospitalizations and deaths by 89 percent. 

Significance: 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 through preventing deaths and hospitalizations. 

“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along 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 authorization. Merck and its partner Ridgeback Biotherapeutics submitted for authorization of molnupiravir last month.

FDA authorization would likely help more people access a COVID-19 treatment that’s available to take at home.

Read more here.

A MESSAGE FROM EMERGENT BIOSOLUTIONS

Emergent has produced over 100 million Covid-19 vaccine dose-equivalents. Today, these critically important doses are deployed around the world to help fight the pandemic. Get the latest on Emergent’s Covid-19 response.

IN OTHER PFIZER NEWS: ANTIVIRAL PILL TO BE MADE IN POORER NATIONS

Pfizer announced on Tuesday that it is allowing its antiviral COVID-19 pill to be made in poorer nations throughout the world in an effort to help arm them with tools to combat the pandemic.

Pfizer said that under an agreement with the United Nations-backed Medicines Patent Pool (MPP), the company will manufacture and supply the pill in 95 lower-income countries. The agreement covers roughly 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 that are under the agreement for as long as the World Health Organization labels COVID-19 a public emergency of international concern.

Under the deal, MPP will receive a royalty-free license for the antiviral pill from Pfizer. That agreement will permit 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 receives authorization to be used in those locations.

“We must work to ensure that all people — regardless of 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,” Pfizer CEO Albert Bourla said.

Read more here.

Unvaccinated increasingly lean GOP: analysis 

The partisan gap between the vaccinated and the unvaccinated is getting larger. Unvaccinated adults are more than three times as likely to lean Republican than Democratic, a Kaiser Family Foundation analysis found. 

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

Sixty percent of unvaccinated people identify as Republican or Republican-leaning, despite making up 41 percent of the adult population. Meanwhile, 17 percent of the unvaccinated population are Democrats or Democratic-leaning.

The differences between Democrats and Republicans wasn’t always this stark. 

In April, when 43 percent of adults were unvaccinated, 42 percent identified as Republican or Republican-leaning, compared to 36 percent who were or leaned Democratic. 

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

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

Reasons: Looking into why this gap exists, the analysis found that unvaccinated Republicans are more likely to say the news exaggerates the seriousness of the pandemic, and that getting vaccinated is a personal choice. More than half of vaccinated Republicans said the threat of COVID was overstated, but 9 in 10 unvaccinated Republicans were of the same opinion.

Read more here.

 

A MESSAGE FROM EMERGENT BIOSOLUTIONS

At Emergent, we develop, manufacture, and deliver protections against public health threats. Find out how we’ve enhanced and reinforced quality control and oversight practices on our vaccine bulk drug substance manufacturing in support of Covid-19 vaccine production.

 

TWO THIRDS IN NEW POLL SAY GATHERINGS WILL RESEMBLE PRE-PANDEMIC

Two-thirds of Americans say their Thanksgiving gatherings will resemble pre-pandemic ones, a new Monmouth University Poll found. 

The poll found 63 percent of Americans will celebrate Thanksgiving with the same number of people as they did before the coronavirus pandemic with 5 percent saying their will be more people attending their Thanksgiving this year compared to pre-pandemic times. 

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

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

The poll shows 64 percent of individuals hosting Thanksgiving in their home will not ask guests if they have been vaccinated from the virus. Only 27 percent hosts will require guests to be fully vaccinated. 

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

Read more here.

Biden faces uphill climb on vaccine mandate 

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

The move came after a Washington, D.C., judicial panel selected the 6th Circuit court at random from the nation’s 12 regional federal appeals courts and combined the various legal challenges filed across the country into a single lawsuit.

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

The random drawing took place after the New Orleans-based Fifth Circuit Court of Appeals court temporarily blocked the workplace mandate, which requires businesses with at least 100 employees to have their workers either receive the COVID-19 vaccine or submit to regular testing and mask-wearing by Jan. 4.

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

Although the Cincinnati-based Sixth Circuit Court of Appeals, where the case has been reassigned, is considered somewhat less conservative than the Fifth Circuit court that rebuffed 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 & Pathways to Care–Wednesday, November 17 starting 1 PM ET

COVID-19 has presented extraordinary challenges for our nation’s communities and the healthcare systems that serve them. As we move from pandemic response to recovery, how are we addressing the social, economic, and environmental factors that influence health and overall access? Join The Hill for our final Future of Healthcare Summit of the year. Sen. Bill Cassidy, M.D. (R-La.), Rep. Tony Cárdenas (D-Calif.), Andy Slavitt, AMA Past President Dr. Patrice Harris join an exciting line-up for a discussion on advancing access, the pursuit of health equity and resetting the care paradigm. RSVP Today.

WHAT WE’RE READING

• Biden administration to announce purchase of 10 million courses of Pfizer anti-covid pill (The Washington Post)
• Why health-care workers are quitting in droves (The Atlantic)
• Biden administration plans imminent booster expansion to all adults (Axios)
• Flu shots uptake is now partisan. It didn’t use to be (CNN)

 

STATE BY STATE

• Florida lags other states in vaccinating children 5-11 (Tampa Bay Times)
• Metro public health agencies urge Colorado Gov. Jared Polis to issue statewide mask mandate, vaccine passports (Denver Post)
• Missouri’s thin dental safety net stretched amid Medicaid expansion (Kaiser Health News)
• GOP lawmakers in Florida aren’t all in as governor opposes vaccine mandates (Washington Post)

 

OP-EDS IN THE HILL

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

 

That’s it for today, thanks for reading. Check out The Hill’s health care page for the latest news and coverage. See you Wednesday.{mosads}