FDA leader vows transparency on review of vaccines

The head of the U.S. Food and Drug Administration promised that the review of a potential COVID-19 vaccine in theU.S. will be transparent to the public, with any clearance by the agency driven by data alone.

Inan interviewonSunday, CommissionerStephenHahn respondedtoquestionsabout the difffffffffffferent ways the FDA could clear a vaccine for use: either under an emergency authorization, likely based on more limited data and for use in a narrow group, or a broader approval that could lead to wider use.

“We’ve saidall alongwe’re not going to pre-judge what mechanism we’re going to use to authorize or approve a vaccine,” Hahn told Bloomberg News by phone. “We’re going to let the data dictate that. The data willdictate what kind of decision is made on the vaccine.”

No decision on that has been made, because the agency hasn’t seen trial results yet, he said.

“I don’t have a crystal ball, I don’t know what the data look like,” Hahn said.

Hahn was appointed by PresidentDonaldTrumplate last year. Only months into his tenure he found himself at the center of the administration’s response to the coronavirus, whichhas killed more than 180,000 Americans and infectedmore than 5.9 million. Avaccine is considered crucial for ending the pandemic and reviving the U.S. economy.

A vaccine is also pivotal to Trump’s reelection. The president has said a vaccine could be available by Election Day on Nov. 3, and on Twitter has attacked Hahn’s agency for harboring “deep state” staffff slowing vaccine and drug work to hurt him politically.

There’s no evidence that’s the case, and in fact the agency found itself in the middle of turmoil over the last week after Hahn, at a news conference with Trump, announced the emergency authorization of aCOVID-19 therapy that uses blood plasma from recovered patients to treat current ones. At the news conference, Hahnoverstatedthe benefifits of the therapy— and had his remarks echoed by others in the administration.

Hahn apologized a day later. But the error led to a week of criticism of the agency, and the removal of theFDA’snewspokeswoman, Emily Miller, after less than two weeks in the job. Miller didn’t respond to requests for comment Friday.

The result is an agency trapped between Trump’s accusations that it is moving too slowly, and outside criticswho fearWhiteHouse pressure will cause it to rush a vaccine review, or clear a shot based on insufficient data about its safety and effffffffffffectiveness.

Hahn, in the interview, said the agency will share as much of the data on any vaccine it reviews as is possible. The agency has scheduled an Oct. 22 meeting of outside experts to discuss a vaccine. At this point, however, large, fifinal- stage trials of experimental shots by Pfifizer Inc., Moderna Inc. and others haven’t been completed or offered enough data to make a public judgment on.

“We are committed to being transparent because werealize this is very important to the American people,” he said.