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Trump pressures FDA to approve COVID vaccine fast

December 12, 2020

US President Trump has told US drug regulators to accelerate emergency authorization of the BioNTech-Pfizer vaccine. President-elect Joe Biden has said the vaccine needs to be evaluated "free from political influence."

US President Donald Trump at a vaccine summit
Donald Trump has said FDA authorization of a vaccine is too slow Image: Evan Vucci/AP Photo/picture alliance

The Trump administration on Friday reportedly told the head of the US Food and Drug Administration (FDA), Stephen Hahn, to grant emergency authorization for BioNTech-Pfizer vaccine by the end of the day or potentially lose his job, two administration officials told the Washington Post.

On Thursday, an independent expert panel gave the FDA a green light to authorize the vaccine. Before it can be authorized and distributed, FDA regulators and scientists must work out last minute details, including a fact sheet for doctors.

Hahn later said the conversation with White House Chief of Staff Mark Meadows was misrepresented.

"This is an untrue representation of the phone call with the chief of staff," Hahn said in a statement. "The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech's EUA [emergency use authorization] request. FDA is committed to issuing this authorization quickly."

However, the alleged threat came as Trump tweeted that the FDA was a "big, old, slow turtle," told Hahn to "stop playing games," and get the "dam" vaccine out now.

Injecting science with politics 

Critics have said the rush to authorize could undermine US public confidence in the vaccine by injecting science with politics. Hahn has stated for months that "science, not politics" would determine when the FDA authorizes the vaccine.

President-elect Joe Biden said during a speech Friday that he was grateful for scientists and experts who evaluate the safety and efficacy of the vaccine "free from political influence."

"These are first-rate scientists taking their time looking at all of the elements that need to be looked at," Biden said, while urging the public to "have confidence" in the vaccine.

Authorization expected soon 

Even without Trump's pressure, the vaccine was already widely expected to be authorized by the FDA within the next couple of days.

FDA boss Stephen Hahn
FDA chief Stephen Hahn said the phone call with the White House was 'misrepresented'Image: Alex Edelman/abaca/picture alliance

"The FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccine, so in the next couple of days ... we should be seeing the authorization of this first vaccine," US Health and Human Services Secretary Alex Azar told broadcaster ABC News on Friday.

"We will work with Pfizer to get that shipped out so we could be seeing people getting vaccinated Monday, Tuesday of next week," Azar added.

Azar said this week the US hopes to have 20 million people inoculated this month.

If approved by the FDA, the BioNTech-Pfizer vaccine would be the first to be used in a mass inoculation program. The US has already ordered 100 million doses of the vaccine, which would inoculate 50 million people, as the vaccine is given in two doses. 

The US is the worst-hit country in the world by coronavirus, with over 15,780,000 total cases and over 294,000 total deaths. On Friday alone, over 171,000 new infections have been reported and over 2,000 people have died, according to the Johns Hopkins University. 

'Expect the unexpected' as vaccinations begin

wmr/aw (AP, AFP, dpa)