The vaccine produced by Pfizer Inc. and its German partner BioNTech won critical approval from a panel of outside FDA advisers on Thursday, and the agency’s approval – which was expected this weekend – is next. necessary step to obtain vaccines to the public.
The FDA is under no obligation to follow the advice of its advisory committees, but the devastation caused by the virus makes authorization of the vaccine almost certain.
Meadows spoke to Hahn by phone on Friday, according to a senior administration official who was aware of the call but was not authorized to discuss private conversations.
The chief of staff also told Hahn his job was in jeopardy if the emergency use permission was not issued by Saturday, a second administration official familiar with the conversation said.
Hahn has indicated that he will ask regulators to authorize the release of the vaccine on an emergency basis, the official said.
President Donald Trump pushed for rapid approval of the vaccine and tweeted directly to Hahn earlier Friday, complaining that the FDA “is still a big, old, slow turtle.” Trump has publicly criticized the pace of the FDA vaccine review process.
“Get the vaccines out of the dam NOW, Dr Hahn,” Trump tweeted on Friday. “Stop playing games and start saving lives. ”
Hahn disputed the characterizations of his conversation with Meadows.
“This is a misrepresentation of the phone call with the chief of staff,” Hahn said in a statement. “The FDA was encouraged to continue to work expeditiously on Pfizer-BioNTech’s EUA application. The FDA is committed to getting this clearance done quickly, as we noted in our statement this morning. ”
The FDA said earlier Friday it will “work quickly” to authorize emergency use of the vaccine.
Dr Ashish Jha, dean of the School of Public Health at Brown University, called the pressure an “unforced error” by the White House that could undermine public confidence in a vaccine.
“It creates a veneer of political interference,” Jha said. “Every time you see the president getting involved, you see vaccine confidence drop 10%.”
Hahn and other senior health officials have been working for months to build public confidence in the government’s vaccination effort, which will ultimately need to reach most Americans to suppress the virus.
Recent polls show that only about half of Americans are willing to roll up their sleeves for a shot. Many have security concerns and want to wait and see how the initial deployment unfolds. But fears 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 public confidence in the vaccine with political pressure to speed up an already rushed process with threats of layoffs,” said Carl Tobias, professor of law at the University of Richmond, Virginia.
Jha added that FDA officials didn’t need the extra pressure. “They are already feeling the weight of what is happening in our country,” he said.
Trump’s frustration with the FDA has grown, especially as other countries have beaten the United States by issuing emergency approvals for the vaccine. Meadows issued the ultimatum to Hahn under Trump’s leadership, a senior administration official said.
The FDA’s decision – when it comes – will launch an unprecedented vaccination campaign needed to ultimately defeat the virus, now blamed for nearly 300,000 deaths in the United States and the agency’s green light for the vaccine has been virtually assured after Thursday’s positive vote by the agency’s advisers.
Generally, the FDA does not publicly comment on the progress or timing of its reviews, which are considered confidential government information.
FDA review is critical to ensuring the safety and efficacy of a vaccine that will eventually be given to millions of Americans, including highly vulnerable groups like residents of nursing homes.
The agency’s cautious approach is unique in the world in that the FDA actually reanalyzes all company data for accuracy. This is different from the shorthand process used by the UK and other countries, which is based on summary data produced by manufacturers.
Hahn has said for months that “science, not politics” will determine when the agency gives the vaccine the green light.
He surprised many critics in October by defying the White House and issuing strict FDA safety guidelines for upcoming COVID-19 vaccines. The standards effectively shut the door on Trump’s long-standing goal of providing a vaccine before election day and undermined White House staff who had blocked the guidelines for weeks.,
More than 150 FDA staff worked shifts overnight, weekends, and Thanksgiving holidays to review tens of thousands of pages of the Pfizer app.
Hahn told The Associated Press earlier this week that his agency had already canceled the authorization by first completing all necessary legal documents.
“We’re doing everything we can to cut red tape, which I think is really important,” Hahn told the AP.
Trump has been furious with the FDA for not moving faster to approve the vaccines, blaming a vaccine not being available until the Nov. 3 election for its loss. Trump has also made unsubstantiated claims that drug companies have deliberately delayed vaccine development to hamper his chances of re-election, although there is no evidence to suggest this has taken place.
As he refused to accept his defeat to Democratic President-elect Joe Biden, Trump also told close relatives that he thought the vaccine was still slow in an effort to undermine his efforts to challenge the results.
If the vaccine was shipped sooner, he argued, it would rally public opinion to his side.
Lemire reported from Wilmington, Del. Associated Press writer Zeke Miller contributed to this report.