White House threatens FDA chief’s job over vaccine approval
WASHINGTON, DC, United States (AP) — White House chief of staff Mark Meadows yesterday pressed Food and Drug Administration (FDA) chief Stephen Hahn to grant an emergency use authorisation for Pfizer’s coronavirus vaccine by the end of the day or face possible firing, two administration officials said.
The vaccine produced by Pfizer Inc and its German partner Biontech won a critical endorsement Thursday from an FDA panel of outside advisers, and sign-off from the agency — which was expected this weekend — is the next step needed to get the shots to the public.
The FDA is not required to follow the panel’s guidance, but the devastation caused by the virus makes the vaccine’s authorisation almost certain.
Meadows spoke to Hahn by telephone yesterday, according to a senior administration official who was familiar with the call but was not authorised to discuss private conversations.
The chief of staff also told Hahn his job was in jeopardy if the emergency use authorisation was not issued before today, said a second administration official familiar with the conversation.
Hahn signalled that he would tell regulators to grant the decision, the official said.
President Donald Trump has been pressing for quick approval for the vaccine and tweeted directly at Hahn earlier yesterday, complaining that FDA “is still a big, old, slow turtle”. Trump has publicly bashed the pace of the FDA’S vaccine review process.
“Get the dam vaccines out NOW, Dr Hahn,” Trump tweeted yesterday. “Stop playing games and start saving lives.”
Hahn disputed characterisations of his conversation with Meadows.
“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 PfizerBiontech’s EUA request. FDA is committed to issuing this authorisation quickly, as we noted in our statement this morning.”
The FDA said earlier yesterday that it “will rapidly work” to finalise emergency use of the vaccine.
Dr Ashish Jha, dean of Brown University’s school of public health, called the pressure an “unforced error” by the White House that could chip away at public confidence in a vaccine.
“It creates a veneer of political meddling,” Jha said. “Every time you see the president get involved, you see vaccine confidence drop by 10 per cent.”
Hahn and other top health officials have been working for months to boost public confidence in the government’s vaccine effort, which will eventually need to reach most Americans to suppress the virus.
Recent polls show only about half of all Americans are ready to roll up their sleeves for a shot. Many have safety concerns and want to wait and see how the initial roll-out fares. But concerns that a vaccine was rushed due to political pressure could further undermine the unprecedented vaccination effort.
“The last thing this process needs now is to undermine the public’s faith in the vaccine with political pressure to hurry up an already rushed process with threats of firings,” said Carl Tobias, law professor at the University of Richmond in Virginia.
Jha added that FDA officials don’t need the added pressure. “They already feel the weight of what’s happening in our country,” he said.
Trump’s frustration with the FDA has been mounting, particularly as other countries have beaten the US in issuing emergency approvals for the vaccine. Meadows issued the ultimatum to Hahn at Trump’s direction, a senior administration official said.
The FDA decision — when it comes — will kick-start an unprecedented vaccination campaign needed to eventually defeat the virus, now blamed for nearly 300,000 deaths in the US and the agency’s greenlight of the vaccine was virtually assured after Thursday’s positive vote by agency advisers.
In a separate move yesterday, Trump Administration officials announced the purchase of 100 million additional doses of a different upcoming vaccine from drug maker Moderna. That’s on top of a previous purchase of 100 million doses. FDA’S expert advisory panel is scheduled to review that vaccine next Thursday, with a decision soon thereafter.
FDA’S review is critical to assuring the safety and effectiveness of vaccine that will eventually be given to millions of Americans, including highly vulnerable groups like nursing home residents.
The agency’s careful approach is unique around the world in that the FDA actually reanalyses all company data to verify its accuracy. That’s different from the abbreviated process used by the UK and other countries, which rely on summary data produced by manufacturers.
Hahn has stated for months that “science, not politics” would determine when the agency gives the vaccine the go-ahead.
More than 150 FDA staffers have been working in shifts over nights, weekends and the Thanksgiving holiday to review tens of thousands of pages of Pfizer’s application.
Hahn told The Associated Press earlier this week that his agency had already teed up authorisation by prefiling all the necessary legal paperwork.
“We’re doing everything we can to cut down on the red tape, which I think is really important,” Hahn told the AP.
Trump has been livid with the FDA for not moving faster to approve the shots, blaming the fact that a vaccine was not available before the November 3 election for his loss. Trump also has levelled unfounded claims that drug companies deliberately delayed vaccine development to hinder his re-election chances, though there is no evidence to suggest that took place.
As he has refused to accept his loss to Democratic President-elect Joe Biden, Trump also has told close confidants that he believes the vaccine is still being slowwalked in a bid to undermine his efforts to challenge the results.
If the vaccine were shipped out sooner, he has argued, it would rally public opinion to his side.