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FDA commissioner Stephen Hahn and President Trump. Photo: Chip Somodevilla/Getty Images

The uproar over the FDA's authorization for the use of convalescent plasma in coronavirus patients is only partially about convalescent plasma. It's also about a vaccine that doesn't exist yet, and trust in the FDA's eventual stamp of approval.

The state of play: The FDA has been forced to defend itself on both fronts.

  • Peter Marks, who leads the relevant division within the FDA, said at a news conference yesterday that the evidence of plasma's effectiveness "more than adequately met" the standards for emergency use, noting that there is little question about its safety, per the Wall Street Journal.

And FDA commissioner Stephen Hahn, in an interview with Bloomberg's Drew Armstrong, owned up to a mistake in how he described the effectiveness of convalescent plasma while also addressing bigger-picture concerns about the FDA's independence.

  • "Yeah, I'm aware of it. I've listened to all the conversations," Hahn told Bloomberg when asked about political pressure. "But what I tell internally our folks is they need to make the decisions based upon the data. I have not reversed one of their decisions, nor do I intend to unless I think it's absolutely wrong."
  • Hahn also said he wasn't present when White House economic adviser Peter Navarro berated FDA officials as members of the "Deep State" and told them to "get on Trump Time."
  • He said he "would not participate in any decision that was made on anything other than the science."

Go deeper

What COVID-19 vaccine trials still need to do

Illustration: Sarah Grillo/Axios

COVID-19 vaccines are being developed at record speed, but some experts fear the accelerated regulatory process could interfere with ongoing research about the vaccines.

Why it matters: Even after the first COVID-19 vaccines are deployed, scientific questions will remain about how they are working and how to improve them.

Dec 3, 2020 - Health

WSJ: Pfizer expects to ship half as many COVID vaccines as planned in 2020

A Pfizer factory in Puurs, Belgiam on Dec. 3. Photo: Kenzo Tribouillard/AFP via Getty Images

Pfizer and BioNTech have halved their original estimates for how many coronavirus vaccines would be shipped globally by the end of this year, citing supply-chain issues, the Wall Street Journal first reported.

Why it matters: The U.K. government has ordered 40 million doses of Pfizer-BioNTech's vaccine — enough to inoculate some 20 million people. The companies now expect to ship 50 million vaccines by the end of 2020, per WSJ.

Romney: Trump's lack of leadership on COVID-19 is "a great human tragedy"

Sen. Mitt Romney and President Trump. Photo: Alex Wong/Getty Images

GOP Sen. Mitt Romney (Utah) told CNN Thursday that President Trump's lack of leadership during the coronavirus pandemic is "a great human tragedy."

Driving the news: Trump has largely stayed silent on the country's worsening pandemic in recent weeks, even as the U.S. experienced a record daily death toll and hospitalizations surpassed 100,000 for the first time. Instead, the president has focused much of his public commentary on pushing baseless claims of widespread election fraud.