WASHINGTON — Food and Drug Administration Commissioner Stephen Hahn was summoned to the White House on Tuesday to answer questions about why his agency has not yet granted emergency use authorization for a COVID-19 vaccine developed by Pfizer and its German partner, BioNTech.
What You Need To Know
- FDA Commissioner Stephen Hahn and White House chief of staff Mark Meadows will reportedly meet Tuesday
- Meadows is expected to ask Hahn why the FDA has not yet granted emergency use authorization for a COVID-19 vaccine developed by Pfizer and BioNTech
- President Donald Trump has been livid with the FDA for not moving faster on the vaccine, blaming it in part for his reelection loss
- In a statement Monday night, Hahn defended the pace of the approval process, saying career scientists "will take the time that's needed to make the right call"
Axios was the first to report on the meeting between Hahn and White House chief of staff Mark Meadows, which began around 9:30 a.m.
Pfizer and BioNTech applied for emergency use authorization on Nov. 20. President Donald Trump has been livid with the FDA for not moving faster on the vaccine, blaming it in part for his reelection loss. He has also leveled unfounded claims that drug companies deliberately delayed vaccine development to hinder his chances.
Hahn had requested that the conversation with Meadows be held by phone, but Meadows insisted on a face-to-face meeting, reports said.
In a statement to Axios on Monday night, Hahn defended the pace of the approval process, saying, "Let me be clear — our career scientists have to make the decision and they will take the time that's needed to make the right call on this important decision.”
The FDA has scheduled a Dec. 10 meeting of its outside advisory panel to discuss Pfizer and BioNTech’s application. The agency announced Monday it has also scheduled a Dec. 17 meeting to discuss the emergency use authorization request for a separate vaccine candidate, developed by Moderna Inc.
Pfizer announced last month that its vaccine is 95% effective and has no serious side effects.
An FDA spokesperson told Axios that the agency received thousands of pages of data that was then divvied up to experts for review. Once those reviews are complete, they are integrated into an overall review.
"Completion of these reviews involves such things as ensuring that the manufacturing process and the controls on manufacturing are appropriate, checking statistical analyses performed to ensure that they were done properly and doing additional analyses, as necessary, to look at the effect of the vaccine on subsets of individuals who might be at greater risk of adverse effects,” the spokesperson said.
Tuesday's meeting came as the FDA weighed whether to authorize two experimental vaccines that have been raced through development. Many Americans already harbor concerns about the potential impact of political pressure on vaccine development, and public health officials have been trying to provide reassurance that the approval process has been free from influence.
Meanwhile, a separate scientific panel was tackling the pressing question of who should come first for vaccinations when they become available. The government’s Advisory Committee on Immunization Practices will make recommendations to the Centers for Disease Control and Prevention on shots to fight the disease, which has killed nearly 270,000 Americans.
The White House did not immediately respond to requests for comment about the purpose of the meeting meeting with the FDA's Hahn. But many aides to the president recognize that it would look bad for Trump to lose Hahn on the cusp of vaccine authorization. And some expressed concern Tuesday that the White House meeting was even happening, for fear that it could undercut efforts to frame the vaccine as a positive part of Trump’s legacy.
But the president has been fuming since he lost his reelection bid and believes that, had a pair of drug companies released data showing that their vaccines were effective before Election Day, he would have have won. He has complained repeatedly about not getting the credit he believes he deserves for the vaccine development.
A scientific researcher and former hospital executive, Hahn has clashed with Trump repeatedly amid the president's unsubstantiated suspicions that FDA scientists were working to undermine him.
To the contrary, in the first months of Hahn's tenure, former FDA staffers and outside experts criticized the FDA chief for decisions that many viewed as bowing to the White House and failing to protect the agency’s science-based decision-making process. More recently Hahn has resisted White House pressure for hasty vaccine approval.
In October, Hahn published strict FDA safety guidelines that effectively closed the door on Trump’s goal of delivering a vaccine by Election Day. And he has repeatedly testified to Congress that “science, not politics,” would determine when a vaccine was made available.
Trump's anger with the FDA and drug companies only escalated after the election, according to White House aides and a Republican close to White House who spoke on condition of anonymity to discuss private conversations. And Trump has been telling confidants that the vaccine is still being slow-walked, post-election, to hurt his chances of contesting the outcome.
For months, he has told friends that he believes Hahn slowed down or undersold the benefits of other therapeutics — including blood plasma — despite evidence to the contrary — and has “never been on the team.” He has also claimed both privately and publicly that drug companies are punishing him for his efforts to lower prescription drug prices, and has made unsupported allegations that Pfizer and others have formed an informal Deep State-like cabal with the FDA and the media to hurt him.
Amid his anger, he has been telling allies that he was assured the vaccine would be out by October and now believes it was either deliberately delayed or that he was given incorrect information to make him look bad and hurt his chances of winning.
Meanwhile, the administration has invited leading vaccine manufacturers, distributors and others to a “vaccine summit” next week. Not all invited companies have committed to attending for fear of being perceived as overtly political or being subjected to Trump's attacks.
Though Trump doesn’t give the FDA or Hahn credit, agency scientists were the ones who came up with the idea for “Operation Warp Speed,” the White House-backed effort through which millions of doses of coronavirus vaccines and treatments have been manufactured even as they are being evaluated.
That process — in which money is spent to produce vaccines that may not work — is aimed at cutting months and even years off normal production timelines.