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The FDA's convalescent plasma fallout continues

Caitlin Owens, author of Vitals

President Trump, FDA commissioner Stephen Hahn and HHS Secretary Alex Azar. Photo: Pete Marovich/Getty Images

The National Institutes of Health on Tuesday released a statement undercutting the Food and Drug Administration's emergency authorization of convalescent plasma as a coronavirus treatment — an escalation of an extraordinary public disagreement between federal agencies.

Why it matters: Thankfully, the main question surrounding the treatment is whether it works, not whether it's safe. But this feud could erode public trust in any future coronavirus treatments and vaccines, potentially for good reason.

Driving the news: An NIH panel of experts reviewed the existing evidence on convalescent plasma, including the FDA's analysis, and determined that "there are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19."

  • Although it said that serious adverse reactions to convalescent plasma are rare, the panel wrote that it's still unknown whether the treatment makes patients more susceptible to reinfection.

What they're saying: "The public is best served when health agencies are aligned in the kind of advice they're giving to providers and patients. Different agencies can have different interpretations of data, but the actionable advice should reflect a consensus view so patients have clear guidance," former FDA commissioner Scott Gottlieb told Axios.

  • Another former FDA commissioner, Robert Califf, told Bloomberg that "if you just took random data and divided it into enough subgroups just by chance alone you would find differences."
  • The translation, via Bloomberg's Anna Edney: "It seems the agency did what it doesn't like pharma cos to do — analyze the data a bunch of different ways until something works."

The other side: "Surprised by media uproar on Treatment Guidelines on convalescent plasma for #COVID19. Guidelines mirror EUA: possible benefit, seems safe, randomized trials needed. ... No news here," NIH director Francis Collins tweeted last night.

Go deeper: The FDA plays defense on its coronavirus actions

Go deeper

Eileen Drage O'Reilly
Dec 10, 2020 - Science

The hurdles we face before reaching herd immunity

Illustration: Sarah Grillo/Axios

Once 75%–80% of people get vaccinated against the coronavirus, there should be strong enough herd immunity that we can return to normal activities, NIAID director Anthony Fauci tells Axios.

Driving the news: The FDA is meeting with outside experts today as the agency considers granting an emergency use authorization to Pfizer-BioNTech for their COVID-19 vaccine. A similar meeting is slated for next week to discuss a vaccine developed by Moderna.

Go deeper (3 min. read)Arrow
Axios
Updated Jan 24, 2021 - Politics & Policy

Coronavirus dashboard

Illustration: Eniola Odetunde/Axios

  1. Health: U.S. surpasses 25 million COVID cases.
  2. Vaccine: Cities launch efforts to vaccinate the homeless.
  3. Politics: Deborah Birx went "on the road" for local COVID efforts to avoid White House censorship — Sanders says Democrats will push coronavirus relief package through with simple majority.
  4. Media: Why made-for-TV moments like Amanda Gorman matter during the pandemic.
  5. World: Brazil begins distributing AstraZeneca coronavirus vaccine
Go deeper (1 min. read)Arrow
Felix Salmon, author of Capital
Dec 10, 2020 - Health

An economic tradeoff everyone agrees on

Illustration: Annelise Capossela/Axios

All lives are equally valuable. That's the strong consensus emerging from the many different countries and organizations that have struggled with the question of who should get first access to the COVID-19 vaccine.

Why it matters: The current scarcity of the vaccine looks like an economics problem — too much demand, and not enough supply. But no one is seriously proposing a market-based solution, where the vaccine goes first to those willing and able to pay to jump to the front of the line.

Go deeper (1 min. read)Arrow