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Tags: BUSINESS | COS | DRG | EXE | GEN | GOV | HEA

FDA Chief Says Report of Firing Threat Over Vaccine 'Untrue'

FDA Chief Says Report of Firing Threat Over Vaccine 'Untrue'
Trump and Hahn (Getty)

Friday, 11 December 2020 03:50 PM

Stephen Hahn, the head of the U.S. Food and Drug Administration, disputed a report that he had been told to step down if the agency doesn’t authorize Pfizer Inc.’s COVID-19 vaccine on Friday, saying the regulator is working quickly on the clearance.

The Washington Post reported on Friday, citing unidentified sources, that White House Chief of Staff Mark Meadows told Hahn to submit his resignation if the agency doesn’t grant the vaccine an emergency-use authorization by the end of the day. An advisory panel voted 17-4, with one abstention, on Thursday that the benefits of Pfizer’s vaccine, which is it developing with BioNTech SE, outweighed any risks.

“This is an untrue representation of the phone call with the chief of staff,” Hahn said in an emailed statement. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”

President Donald Trump and his administration have placed tremendous political pressure on the FDA to clear the vaccine, which Canada has also approved. Trump in a Friday tweet called the FDA “a big, old, slow turtle,” and demanded Hahn “get the dam vaccines out NOW.”

The Pfizer vaccine is expected to gain an emergency-use authorization imminently, to be followed by a mass inoculation effort unparalleled in American history. A formal go-ahead from the FDA will set in motion a nationwide distribution effort, starting with 2.9 million doses being made available to states. Health and Human Services Secretary Alex Azar told ABC that Americans may start getting shots as soon as Monday.

Side-Effect Scrutiny

The FDA is scrutinizing recent reports of allergic reactions to the vaccine as it readies an emergency-use authorization -- a step that could come as soon as this weekend, according to top U.S. health officials.

One of the last things the FDA does before clearing a product for public use is make sure the instructions for doctors and patients on the label include up-to-date information about who should use it and how.

In the past several days, there have been reports of serious allergic reactions to the vaccine in the U.K. After starting immunizations Tuesday, the U.K.’s National Health Service said people with a significant history of allergies shouldn’t receive the shot. The FDA is seeking more information on the allergic reactions from the U.K. drug regulator, Marion Gruber, director of the Office of Vaccines Research and Review, told a committee of agency advisers Thursday.

“That’s something we’re working with Pfizer right now on is the appropriate language for the doctors, is if you have a pre-existing serious allergic reaction to anything in these vaccines or medical allergies, you should exercise caution in getting these vaccines initially,” Azar said on Friday in an interview with Fox Business News.

Still, any final hurdles are expected to be cleared in relatively short order. The FDA is working toward a rapid authorization of the shot, and has “notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” the agency said in a statement Friday. Azar tweeted that Pfizer has already been advised that the authorization was coming.

As of Friday, the pandemic had killed more than 292,000 Americans, and confirmed cases topped 15.6 million. A new surge of cases in the aftermath of the Thanksgiving holiday has strained hospital capacity nationwide.

Pfizer declined to comment. The shares fell as much as 2.5% as of 2:15 p.m. in New York. American depositary receipts of BioNTech SE, Pfizer’s partner in developing the shot, lost as much as 3.8%.

Other Effects

Thursday’s FDA advisory panel discussion touched on incidents of Bell’s palsy, a temporary facial paralysis that was experienced by four people who received Pfizer’s vaccine in clinical trials. No one in the placebo group reported the condition.

FDA staff said the number of Bell’s palsy cases was consistent with the rate of the condition in the general population, and there was no reason to believe it was related to the vaccine, but some advisers were skeptical.

The FDA has asked Pfizer to conduct surveillance for Bell’s palsy cases in vaccine users in the general public. The agency may want to flag the issue on the vaccine’s label, in light of the advisory panel’s discussion.

“At this point it’s really a matter of working out some of the final details -- dotting the i’s, crossing the t’s, getting the fact sheet for the doctors,” Azar told Fox.

The panel also considered whether there was enough data to support the vaccine’s use in 16- and 17-year-olds, leaving some members uncomfortable with voting in its favor. However, others said data from older trial participants could be extrapolated to younger people.

Clinical-trial data has shown that Pfizer’s vaccine is 95% effective in preventing symptomatic COVID. It isn’t yet known whether the vaccine can prevent transmission of the disease. Pfizer has said it plans to file with the FDA for a full approval for the shot in April.

© Copyright 2021 Bloomberg News. All rights reserved.


Politics
Stephen Hahn, the head of the U.S. Food and Drug Administration, disputed a report that he had been told to step down if the agency doesn't authorize Pfizer Inc.'s COVID-19 vaccine on Friday, saying the regulator is working quickly on the clearance. The Washington Post...
BUSINESS, COS, DRG, EXE, GEN, GOV, HEA, INDUSTRIES, NORTHAM, US, WORLD, WWTOP
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2020-50-11
Friday, 11 December 2020 03:50 PM
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