Welcome to Friday’s Overnight Health Care.
FDA authorization of Pfizer’s COVID-19 vaccine candidate is expected soon, but the White House is pushing the agency to move even quicker. Meanwhile, the Trump administration is buying another 100 million doses of a similar candidate from Moderna. And a surprise billing fix might happen after all.
Let’s start with the COVID vaccine:
White House presses FDA chief over COVID-19 vaccine
Top Trump administration officials are turning up the heat on the Food and Drug Administration (FDA) to quickly authorize emergency use of the country’s first coronavirus vaccine.
White House chief of staff Mark Meadows phoned FDA Commissioner Stephen Hahn on Friday and pushed him to clear the Pfizer/BioNtech vaccine by the end of the day, according to an official familiar with the matter.
According to multiple reports, Meadows suggested to Hahn that his job was in jeopardy if the agency did not act. The Washington Post first reported that Meadows told Hahn to submit his resignation if the vaccine doesn’t receive an emergency use authorization by the end of the day.
In a statement to The Hill, Hahn denied that there was any threat to his job, or that Meadows pressured him in any way.
“This is an untrue representation of the phone call with the Chief of Staff. The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA [emergency use authorization] request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning,” Hahn said.
Past evidence: But the conversation between Hahn and Meadows happened the same day President Trump tweeted his disapproval to Hahn, and called the FDA “a big, old, slow turtle.”
He tagged Hahn in the tweet, telling him to “[g]et the dam [sic] vaccines out NOW.” He added that Hahn should “[s]top playing games and start saving lives!!!”
What’s next: The pressure reportedly led the FDA to accelerate its timetable for clearing America’s first vaccine from Saturday to later Friday. Once FDA gives authorization, a panel from the Centers for Disease Control and Prevention will vote on which groups should and should not get the vaccine, and then it will be able to get injected into people.
The consequence: It’s not clear why Trump and Meadows want to pressure Hahn, and it’s not likely a decision Friday would make any difference in when the first vaccine doses can get delivered. The agency’s process is designed to leave no room for public doubt, especially since a vaccine was developed and submitted for review in record time. The Trump White House decided to inject politics into science, yet again.
Trump administration buys another 100 million doses of Moderna COVID vaccine
The Trump administration doesn’t want to be caught flat-footed on the next round of vaccines, announcing it will purchase another 100 million doses of Moderna’s COVID-19 vaccine candidate.
The vaccine is still pending emergency authorization from the Food and Drug Administration (FDA), but that is expected to come as soon as next week.
The U.S. had previously ordered 100 million doses of the vaccine earlier this year, and those will begin shipping immediately upon FDA authorization, with 20 million expected by the end of December.
The second batch of 100 million doses purchased by the U.S. Friday will be delivered in the second quarter of next year.
“Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines,” said Alex Azar, secretary of the Department of Health and Human Services.
Why it matters: The announcement comes after the administration was criticized for passing up opportunities to purchase additional doses of Pfizer’s vaccine, leading to concerns about supply shortages. FDA authorization of the Moderna and Pfizer vaccines appears imminent, but it will take a long time before enough doses are sent out to vaccinate the entire population.
But it’s not all good news on the vaccine front…
Sanofi, Glaxo announces setback in coronavirus vaccine project
Sanofi and GlaxoSmithKline (GSK) on Friday announced a setback in their coronavirus vaccine project, saying they now expect their vaccine to be available next year.
The companies said in a joint statement that interim results from a phase 1/2 trial showed the vaccine produced a low immune response in older adults, which it said was likely due to an insufficient concentration of the antigen.
The vaccine did elicit an immune response in adults 18-49 years old that the companies said was comparable to that seen in recovered COVID-19 patients.
U.K.-based GSK and French company Sanofi said they will conduct a phase 2b study in February 2021. Phase 3 confirmatory trials, which were originally slated for this month, are now expected to begin by the second quarter of 2021.
The companies now think the vaccine will be available from mid-2021 to the fourth quarter of 2021. They were originally planning to begin the trial this month.
Committees reach bipartisan deal to protect patients from surprise medical bills
Four congressional committees on Friday reached a bipartisan deal on legislation to protect patients from massive “surprise” medical bills after a series of tense negotiations, according to congressional aides.
Backers of the deal are hoping to include it in the year-end spending package slated to go through Congress next week.
The deal was struck by the leaders in both parties of the Senate Health and House Energy and Commerce, Education and Labor and Ways and Means Committees, though it would still need buy-in from leadership to be added to the year-end package.
Sanders, Hawley vow fight next week over stimulus checks
Sens. Josh Hawley (R-Mo.) and Bernie Sanders (I-Vt.) are warning they will use next Friday’s government funding deadline to try to force a vote on a second round of stimulus checks amid lawmakers’ failure to secure a deal on another coronavirus relief package.
“This Congress must address the economic emergency facing the American people. We cannot go back to our families during the Christmas holidays while tens of millions of families are suffering,” Sanders said during a floor speech.
While Sanders and Hawley allowed a one-week continuing resolution to clear on Friday, averting a shutdown, they are warning about a showdown next week on their proposal.
The two senators are calling for a vote on their proposal that would provide a $1,200 check for individuals who make up to $75,000 – mirroring language included in the March CARES Act.
Progressives and Hawley are pushing for a second round of direct payments. Neither a proposal from a bipartisan group of lawmakers nor one from Senate Majority Leader Mitch McConnell (R-Ky.) included the stimulus checks.
GOP leadership has warned that stimulus checks divide their caucus and could beef up the price tag, which could also threaten Republican support.
Virtual Event Announcement: 1:00 ET Wednesday 12/16 — COVID-19, Tech and Economic Resilience
Significant advances in communication and information technology have lifted many, and buffered others, during a crushing pandemic. As a new administration prepares to take charge, which technology shifts are here to stay? How can policymaking keep pace to ensure the American economy retains its competitive edge? In the first of three virtual events, The Hill discusses the role of technology in re-energizing the American economy. Sen. Tim Scott, Rep. Suzan Delbene, Janet Napolitano, Amb. Ron Kirk, FCC Commissioner Jessica Rosenworcel, Microsoft’s Fred Humphries. RSVP for event reminders (https://techpolicyandresilience.splashthat.com/).
What we’re reading
COVID-19 vaccine-distribution timeline will keep slipping, experts say (STAT)
Coronavirus debate: Should lawmakers get vaccines first? (The Wall Street Journal)
Supply is limited and distribution uncertain as COVID vaccine rolls out (Kaiser Health News)
State by state
How many vaccine doses will your state get? (The New York Times)
Illinois lawmakers propose cut in Medicaid rates (The Herald-News)
He treated Houston’s most desperate Covid patients. Then he became a victim. (NBC News)