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FDA commissioner Stephen Hahnduring a press conference at the White House on Sunday. Photo: Pete Marovich/Getty Images

FDA commissioner Stephen Hahn said in a Twitter thread Monday night criticisms of his comments about granting an emergency use authorization (EUA) of convalescent plasma as a treatment for the coronavirus were "entirely justified."

The big picture: Hahn also addressed in his post the politicization of the FDA, in an apparent reference to President Trump and his trade adviser, Peter Navarro, accusing senior health officials of being part of the "Deep State" amid a decision to put the plasma treatment on hold.

  • Trump said at a news conference Sunday night the plasma "has proven to reduce mortality by 35%. Hahn echoed these remarks, saying: "What that means is -- and if the data continue to pan out -- 100 people who are sick with Covid-19, 35 would have been saved because of the administration of plasma."

What he's saying: Hahn said in his Twitter post that what he should have said better was that "the data show a relative risk reduction not an absolute risk reduction.

  • "The authorization of emergency use of convalescent plasma is not a final approval. FDA will continue to monitor its use and will revoke authorization if needed. We feel broader use of plasma will truly benefit many patients but will require further study," he added.
  • "The convalescent plasma decision was made entirely by FDA scientists. We at FDA do not permit politics to enter into our scientific decisions. This happens to be a political season but FDA will remain data driven. On behalf of FDA‘s 18,000 career employees, I want to reassure the American public about this commitment."

Of note: Hahn stressed that the decision was based on "significant data" from reliable sources including the Mayo Clinic, "plus a century of experience with convalescent plasma."

  • "We unfortunately do not have randomized trials for convalescent plasma but must make decisions based on what we do have from the Mayo Clinic expanded access program," he said.
  • "They had confidence that convalescent plasma has potential to benefit many sick patients and the safety profile is well defined.
"Media coverage of FDA’s decision to issue emergency authorization for convalescent plasma has questioned whether this was a politically motivated decision. The decision was made by FDA career scientists based on data submitted a few weeks ago."

Editor's note: This article has been updated with new details throughout.

Go deeper

Updated Dec 7, 2021 - Politics & Policy

Omicron dashboard

Illustration: Shoshana Gordon/Axios

  1. Health: Americans shrug off Omicron, Axios-Ipsos poll finds — CDC director says number of U.S. Omicron cases "likely to rise."
  2. Vaccines: Omicron gives a shot to boosters — U.S. announces $400M for global COVID vaccine distribution — Vaccine mandates lose steam in the U.S. while Europe doubles down.
  3. States: Gov. Hochul will order some NY hospitals to halt elective surgeries — Nevada to impose insurance surcharge on unvaccinated state workers.
  4. World: EU drug regulator backs mixing COVID vaccines — Poor global equity likely in COVID pill access — CDC raises travel advisories for France, Portugal to highest level amid COVID surge.
  5. Variant tracker: Where different strains are spreading.
Jan 14, 2021 - Health

Coronavirus deaths climbing while country deals with political unrest

Expand chart
Data: The COVID Tracking Project; Map: Andrew Witherspoon/Axios

Coronavirus deaths continue to reach tragic heights while the country grapples with a vaccine rollout, an impeachment and ongoing civil unrest.

Jan 14, 2021 - Health

SoCal on the brink

A COVID-19 ICU at Martin Luther King Jr. Community Hospital in the Willowbrook neighborhood of Los Angeles. Photo: Patrick T. Fallon/AFP via Getty Images

Southern California's COVID outbreak is in a terrible place, and hospitals haven't even been hit with a wave of potential infections from Christmas and New Year's.

The big picture: Hospitalizations have stabilized, but public health officials say that's just from infections linked to Thanksgiving, the L.A. Times reports.