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Below, the FDA may authorize boosters for all adults as soon as this week, and HHS has slightly shuffled its leadership. But first: 

Effective covid-19 treatments are on tap

The next phase of coronavirus treatments could be game-changing.

Federal regulators are now considering whether to sign off on two different covid-19 antiviral pills — critical medications that promise to stem hospitalizations and deaths. Administration officials and public health experts hope the advent of such easy-to-take treatments will help alter the course of the pandemic in the United States. 

That effort got a big boost yesterday. Within a span of a few hours…

  • Pfizer agreed to a license-sharing deal for its experimental covid-19 pill, which could help more than half of the world’s population get access to the treatment, our colleagues Adam Taylor and Claire Parker report.
  • The company officially requested emergency authorization for its five-day pill regimen from the Food and Drug Administration, per Carolyn Y. Johnson.
  • And the Biden administration is expected to soon announce an agreement to purchase 10 million courses of Pfizer’s pill, The Post’s Tyler Pager and Laurie McGinley scooped.

More from Tyler

Here’s what you need to know: 

1. For all the buzz this week, Pfizer (probably) won’t have the first coronavirus pill on the market.

Merck got to the FDA first. Regulators are already analyzing data the company, and its partner Ridgeback Biotherapeutics, submitted to the agency back in October.

  • Within five days of symptoms, those who contract covid-19 are directed to take the drug twice daily for five days. The medication cut the risk of hospitalization and death by nearly half in a global clinical trial of 775 high-risk, unvaccinated people.
  • The treatment could be available in the United States soon. FDA’s expert committee is slated to discuss the pill’s safety and effectiveness Nov. 30, meaning the agency could sign off after getting the nod from its advisers.

Pfizer’s coronavirus pill could come next. 

  • When given within three days of symptoms, the antiviral reduced the rate of death and hospitalization by 89 percent for those at high-risk of developing severe illness.
  • The clinical trial didn’t include those who became sick with covid-19 after getting vaccinated. But the FDA has the final say over which populations will ultimately be allowed to take the drug, Carolyn notes.

2. There’s one challenge to keep in mind.

Both pills work best if taken within days of symptoms. That means the patient would need to know pretty quickly they’ve contracted the coronavirus. 

To be sure: The availability of tests in the U.S. has soared within the past year. But not all Americans immediately take one when they’re feeling sick, particularly if they’re only experiencing mild, cold-like symptoms. 

Meanwhile, access to tests isn’t as widespread around the globe. 

  • “If you're in a place where you can't get access to testing, then that delays your access to the pills, which reduces the efficacy of the pills themselves,” said Nahid Bhadelia, founding director of Boston University’s Center for Emerging Infectious Diseases Policy and Research.

3. The Biden administration is keeping an eye on supply.

The two coronavirus pills stand out for their ease of delivery. Both can be taken at home — a stark contrast from the small number of other treatments on the market. 

  • For instance, monoclonal antibodies must be infused or injected at a doctors’ office or outpatient center.

But the country will need an ample supply of the pills before they’re able to make a dent in the pandemic’s trajectory, such as relieving overwhelmed hospitals. Production will really rev up next year, though Merck projects 10 million treatment courses ready this year. Pfizer estimates just up to 200,000.

  • Merck’s purchase: The federal government is slated to pay $2.2 billion to purchase roughly 3.1 million courses of the company’s antiviral. The administration has left the door open to buying another 2 million.
  • Pfizer’s purchase: The administration is planning to buy 10 million of Pfizer’s pill, which is a $5 billion investment.

Coronavirus

The FDA is expected to authorize boosters for all adults as soon as this week

Top infectious-disease expert Anthony S. Fauci said on Nov. 16 it's possible for coronavirus to become endemic next year if the U.S. ramps up vaccination rates. (Reuters)

The agency is slated to grant Pfizer-BioNTech’s request to allow extra shots for all American adults this week, The Post’s Katie Shepherd reports. This comes amid rising tensions inside the administration over how quickly to proceed and who should get the extra shot. 

  • The Centers for Disease Control and Prevention’s outside vaccine advisory panel is meeting Friday to discuss expanding eligibility to Pfizer’s booster shot, CDC spokesman Jason McDonald said yesterday. 

Boosters are currently authorized only for seniors and people at high risk of getting the coronavirus due to health conditions, living conditions or their work. But that hasn’t stopped some states from getting ahead of the FDA. Officials in California, Colorado, New Mexico, Arkansas, West Virginia and New York City have broadly endorsed booster shots for all adults.

Here's what else you need to know:

  • D.C.’s local mask mandate, one of the strictest in the nation since late July, will relax beginning Monday, The Post’s Julie Zauzmer Weil and Jenna Portnoy report. Businesses will still be able to require masks, but it will no longer be legally mandated.
  • Two-thirds of Americans say they are planning to celebrate Thanksgiving with the same number of people they did pre-pandemic, up from 46 percent last year, according to a poll from Monmouth University. Democrats are more willing to celebrate outside their house this year. 
  • With nearly a third of American adults still unvaccinated, a new ad campaign is featuring the voices of young people sickened by “long covid” in an effort to motivate people to get vaccinated, our colleague Lena H. Sun reports.
Rob Smith used to run five miles a day, now struggles to climb stairs, maintain a healthy social life, and manage the uncertainty of his coronavirus recovery. (Resolve to Save Lives)

Agency alert

Still vacant: The Department of Health and Human Services slightly shuffled its leadership team. President Biden has yet to nominate five senior officials despite federal vacancy rules kicking in yesterday, our colleague Dan Diamond writes to The Health 202.

  • Deputy commissioner Hope MacDonald LoneTree will take on the responsibilities of commissioner at the Administration for Native Americans, one of three Senate-confirmed positions still open at the Administration for Children and Families. She takes over for Michelle Sauve, who'd previously served as acting commissioner.

But other changes just involved titles, as the Biden administration hit its 300-day mark and the clock ran out for several officials who had served in acting roles.

  • JooYeun Chang will continue to execute the duties of the assistant secretary who oversees ACF, but through her role as principal deputy assistant secretary. Amanda Barlow will continue to execute the duties over the children, youth and families bureau while technically running the division's legislative and budget office.
  • At the Indian Health Service, Elizabeth Fowler will no longer go by the title of “acting director,” but HHS has determined that she can continue to carry out those duties. Same for Alison Barkoff at the Administration for Community Living, who's no longer the “acting administrator” but continuing to handle those responsibilities.

On tap today: The Senate Finance Committee will consider whether to advance two of Biden’s HHS nominees: Samuel Bagenstos to serve as general counsel and Christi Grimm to be the inspector general. 

Industry Rx

First in The Health 202: Over 60 organizations — consisting of unions, employer and patient groups — are urging the Biden administration to implement a new law shielding patients from pricey, unexpected medical bills by Jan. 1. 

In a letter sent to key department leaders, the groups are pushing the agencies to refrain from changing policies included in a much-anticipated rule detailing how to protect patients from surprise bills. They contend the “final rules chose patients over private equity.”

  • One key regulation, released in late September, handed insurers a victory in how a mediator determines payments during a billing dispute.
  • But provider groups have bashed Biden’s regulation. The Association of Air Medical Services sued yesterday, which followed a challenge to the rule the Texas Medical Association filed last month.

Chart check

The biggest divide between the vaccinated and unvaccinated falls along partisan lines.

A new Kaiser Family Foundation poll finds that for every unvaccinated Democrat or Democratic-leaning independent, there are three unvaccinated Republicans or Republican-leaning independents. That’s in a population where each political group is about evenly represented nationally.

Here's a breakdown of the data:

In the courts

An appeals court with mostly GOP-nominated judges will consider Biden’s vaccine mandate

The U.S. 6th Circuit Court of Appeals was chosen, via judicial lottery, to consolidate lawsuits against Biden’s vaccine or test mandate for large employers. That could be good news for the Republican-led states and business organizations challenging the administration’s vaccine and testing requirement for private employers, The Associated Press’s Geoff Mulvihill reports. 

  • Eleven of the 16 full-time judges on the 6th Circuit were appointed by Republican presidents.

How it happened: The court was randomly selected using ping-pong balls to represent 12 circuit courts. A clerk for the judicial panel on multidistrict litigation was charged with selecting one ball from the bin, in a process somewhat reminiscent of a Powerball raffle. The judicial lottery is triggered when challenges are filed against a federal agency in front of multiple courts and must be consolidated to a single court.

An anti-abortion group is ramping up its efforts ahead of a pivotal Supreme Court case. Susan B. Anthony List is unveiling a $2.5 million ad buy ahead of Dec. 1 oral arguments reviewing a Mississippi law that provides a path to diminish Roe v. Wade’s protections. Television ads will begin tomorrow in Washington, D.C., as well as text and digital ads in nine battleground states —part of a broader $10 million ad campaign centering around the Mississippi case. 

In other health news

Sugar rush

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