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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

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.

Updated 3 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Vaccines: CDC says some immunocompromised people can get fourth COVID shot — FDA panel endorses Pfizer vaccines for 5-11 year olds — Moderna says vaccine shows strong immune response in kids
  2. Health: 96% of Tyson Foods employees vaccinated ahead of mandate deadline — U.S. releases updated vaccination, testing rules for foreign travelers — Those who miss work without pay due to COVID also had food insecurity
  3. Politics: Alabama governor orders state agencies to fight federal vaccine mandate — Axios-Ipsos poll: Confidence in Biden COVID recovery tumbles — New York City police union files lawsuit against vaccine mandate.
  4. Education: Benefits of vaccine for children outweigh risks, FDA says — Education secretary reveals limits to Biden’s mask push on states — LA extends deadline for school employee vaccinations.
  5. Variant tracker: Where different strains are spreading.
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.