FDA commissioner says he’s willing to fast-track coronavirus vaccine

Food and Drug Administration Commissioner Stephen Hahn told the Financial Times he would be willing to fast-track the coronavirus vaccine process with an emergency use authorization for certain groups, but insisted he would not do so for politics reasons.

Why it matters: Health experts believe a vaccine — coupled with recommended public health measures — will be the path back to societal normalcy. The decision of when to green-light the vaccine will “likely to be one of the most important and sensitive in U.S. public health history,” writes the FT’s Kiran Stacey.

Details: Hahn said the FDA could issue an emergency use authorization, which is not the same as a full approval, before Phase 3 trials are over if officials believe the benefits outweigh the risk.

  • “We have a convergence of the COVID-19 pandemic with the political season, and we’re just going to have to get through that and stick to our core principles,” Hahn said.
  • “This is going to be a science, medicine, data decision. This is not going to be a political decision.”

The big picture: Hahn’s comments came at the end of a week in which he faced criticism for inaccurately describing the benefits of convalescent plasma at a press conference with President Trump, prompting allegations that the agency has been politicized.

  • Hahn apologized for the error and stressed that he “would not participate in any decision that was made on anything other than the science.”
  • The emergency authorization for plasma, which is safe but not yet proven to definitively work on COVID-19, came after both Trump and White House trade adviser Peter Navarro berated health officials for being part of the “deep state.”

Go deeper: FDA removes top spokesperson after 11 days on the job

Originally published: 2020-08-30 08:03:13

Source link – www.axios.com

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