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Illustration: Annelise Capossela/Axios

Experts who evaluate drugs are getting pushed into a corner.

The big picture: Months after the FDA approved a controversial Alzheimer's drug against the advice of an expert panel and its own statisticians, the Biden administration is pushing for nationwide coronavirus vaccine boosters before independent experts have weighed in.

Driving the news: The Biden administration said booster doses for everyone would begin the week of Sept. 20, pending a "thorough review of the evidence" from the FDA and the CDC's Advisory Committee on Immunization Practices.

Yes, but: The review has barely begun.

  • Pfizer just submitted its application for a third vaccine dose to the FDA, and Moderna has yet to do so.
  • ACIP is rescheduling its Aug. 24 meeting that was going to cover boosters, meaning the panel likely won't make a final call until the end of the month at the earliest.
  • There are no randomized trials evaluating the vaccines against the Delta variant. The most rigorous data available is from the CDC, and the agency has said the reasons behind the vaccines' lower effectiveness "cannot be determined" by those studies.

"The whole idea of following the science is that you let your science go first, and then you follow it," said Walid Gellad, a University of Pittsburgh physician and expert on health policy and pharmaceuticals. "The ramifications of FDA and ACIP saying no, for whatever reason, are much, much bigger now than they were before this press push."

  • "How did you pick the week of Sept. 20? Since this [ACIP] meeting hasn't occurred and you don't know what they’re going to say — this is an independent body — suppose they say: 'We don't think so.' Then what are you going to do with that?" former FDA vaccine head Norman Baylor told Helen Branswell of STAT.

The bottom line: The whole point of expert drug committees is to help shape policy without political or industry influence, but those committees are neutered if their recommendations are ignored or if decisions are made before they even have a chance to say anything.

Go deeper

Updated Oct 19, 2021 - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Vaccines: Mix-and-matching gains momentum — Boosters overtake first doses in U.S. — Pfizer to vaccinate Brazilian cityPanel endorses J&J booster.
  2. Health: Age is still a huge coronavirus risk factor — Unvaccinated 11x more likely to die from COVID — 5x more police officers died from COVID than guns.
  3. Politics: Over 30 states limited public health powers — Pope Francis calls on companies to release vaccine patents — Melbourne, "world's most locked-down city," to lift stay-at-home orders.
  4. Education: Education secretary reveals limits to Biden’s mask push on states — LA extends deadline for school employee vaccinations — Parent sues Wisconsin school district after child tests positive.
  5. Variant tracker: Where different strains are spreading.
24 hours ago - Health

Supreme Court declines to block Maine health care workers vaccine mandate

A Maine health care worker prepares vaccine dose. Photo: Gregory Rec/Portland Press Herald via Getty Images

The U.S. Supreme Court on Tuesday declined to hear an emergency appeal of a vaccine mandate for Maine health care workers.

The big picture: The mandate, which was announced in August by Democratic Gov. Janet Mills, says that Maine health care workers need to be vaccinated by Oct. 29 or risk losing their jobs and not qualifying for unemployment benefits.

Updated 15 hours ago - World

Reports: Brazil leader to be accused of crimes against humanity over COVID

Brazilian President Jair Bolsonaro. Photo: Andressa Anholete/Bloomberg via Getty Images

A Brazilian Senate panel will recommend President Jair Bolsonaro be charged with "crimes against humanity," alleging his COVID-19 pandemic response led to hundreds of thousands of deaths, per the New York Times and the Washington Post.

The latest: The lawmakers initially said Bolsonaro should be charged with mass homicide and genocide, but they updated the report to replace these recommendations with the new charge, its lead author, Sen. Renan Calheiros, told the NYT.