Shortly after Trump heard the news Monday, he demanded Health and Human Services Secretary Alex Azar “get to the bottom” of what happened with Pfizer, according to a senior White House official who spoke on the condition of anonymity to describe the president’s actions.
A few hours later, the issue was front and center at a meeting of the White House coronavirus task force when FDA Commissioner Stephen Hahn briefed members about the vaccine data.
The meeting agenda that day had been drafted so Hahn could walk members through the vaccine approval process, a senior administration official said. Hahn said the timing was the sole result of independent decisions made by Pfizer on collecting and reviewing the information, according to three senior administration officials who spoke on the condition of anonymity to describe internal affairs.
Azar, Hahn’s boss, pointedly contradicted Hahn in front of Vice President Pence, asserting that the FDA’s actions had in fact contributed to a delay in Pfizer’s announcement. He also asked questions that some officials thought suggested Azar believed Pfizer’s timing was affected by political motivations.
Trump weighed in Monday night, tweeting without evidence that the FDA and Pfizer intentionally withheld the news until after the election.
“As I have long said, @Pfizer and the others would only announce a Vaccine after the Election, because they didn’t have the courage to do it before. Likewise, the @US_FDA should have announced it earlier, not for political purposes, but for saving lives!” Trump wrote. “The @US_FDA and the Democrats didn’t want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later — As I’ve said all along!”
Trump’s anger at the FDA raises fresh questions about whether Hahn will hang on to his job until Jan. 20 — when Trump leaves office — in an administration intent on purging officials deemed insufficiently loyal. Trump called Hahn shortly before he tweeted Monday and was “screaming at him” about the Pfizer announcement, in the words of one senior administration official, who spoke on the condition of anonymity to describe sensitive matters. The accusations against the FDA may further fuel baseless conspiracy theories that the election was stolen from Trump.
The FDA and HHS declined to comment.
Although there is no evidence that Pfizer withheld data or did not report it as soon as it was available, a White House official said without evidence that Pfizer “either knew the data and sat on it, or intentionally did not review it as originally planned, in order to push it beyond the election for political purposes.” The official spoke on the condition of anonymity because they were not authorized to speak publicly.
But Pfizer did not have access to the data until the Sunday after the election and could not have known the results before then. Neither the trial participants nor the company knew who was getting the vaccine, and the company did not know how many cases of covid-19, the disease caused by the coronavirus, there were on Election Day. An independent monitoring committee analyzed the data Sunday and informed Pfizer chief executive Albert Bourla, who learned of the results at 2 p.m. that day. The company announced the news the next morning.
An examination of decisions made by Pfizer and the FDA in recent months shows that while their actions inevitably affected the timing of the clinical trial results, there is no proof decisions were made with the intent of imperiling Trump’s reelection prospects.
Rather, the drug company and regulatory agency were reacting to an unprecedented and evolving situation with the goal of dramatically compressing the timeline for vaccine development — it routinely stretches for years — into 10 months without sacrificing safety, according to numerous individuals who were involved in the process or had knowledge of it.
They were also responding to public pressure from scientists who repeatedly voiced concerns that Trump would try to force a vaccine decision before Election Day. On several occasions, Trump said he hoped a vaccine would be ready before Nov. 3. Several Trump administration officials said they were frustrated that some of the scientists expressing concerns included experts advising Trump’s Democratic opponent, Joe Biden.
“What’s going on is they are trying to say there was collusion between FDA and Pfizer to delay this analysis of the trial data so that it wouldn’t benefit Trump in the election, and there’s no basis to that,” said a senior administration official who spoke on the condition of anonymity because he did not have permission to speak about the issue.
Bourla said Election Day did not factor into the company’s decisions.
“If it was before [the election], I would have released it before. If it is now, I’ll release them now. I learned about those results yesterday, Sunday, at 2 o’clock,” Bourla told Axios on Monday.
Wednesday afternoon, two days after Pfizer announced its results, biotechnology firm Moderna announced its vaccine trial had also reached enough cases of covid-19 for an independent data committee to assess whether its vaccine works.
When the clinical trial for the coronavirus vaccine developed by Pfizer and its German biotech partner, BioNTech, began in late July, the pandemic seemed to be coming under control. The company drafted an aggressive timeline for the review of data. The plan, which raised eyebrows among some vaccine experts, was designed to allow an independent monitoring committee to take more frequent and earlier peeks at the data than other manufacturers working on coronavirus vaccines.
The first analysis of the data was scheduled to occur after only 32 cases of covid-19 were reported in a trial that at that time included 30,000 participants. That was about half the number of positive cases being used for initial data analysis by vaccine trials funded and facilitated by Operation Warp Speed, the Trump administration effort to speed up treatments and vaccines.
From the start of the Pfizer trial, the FDA was concerned that 32 cases would be too few and urged the company to wait for more cases, Kathrin Jansen, head of vaccine research and development for Pfizer, said in an interview.
“We heard the FDA, but we were concerned it would take us too long to get to the cases” if it raised the number for the first analysis, Jansen said. “And so the FDA said, ‘Okay, fine, it’s your trial.’ ”
But many in the scientific community expressed concerns that reporting interim data based on just 32 positive cases was insufficient. Critics also questioned the FDA’s plans to use an emergency authorization, rather than full approval, to expedite the vaccine to consumers. Emergency authorization typically relies on much less evidence than full licensure, and the FDA has used the process only once for a vaccine: the anthrax vaccine, under sharply different circumstances.
Fueling the worries were Trump’s repeated promises there would be a coronavirus vaccine by Election Day — a piece of good news he desperately hoped would bolster his chances. Scientists on Twitter and elsewhere said they feared the FDA would be pressured to approve a vaccine before it was proved to be safe and effective.
By the fall, FDA officials, hoping to reassure scientists and the public, were stressing they would apply a rigorous new standard before authorizing a vaccine — one that would be roughly comparable to full approval.
But when the agency tried to publish that new standard, which required two months of follow-up safety data on half the participants, the White House tried to block it, realizing the guidelines made it extremely unlikely a vaccine could be authorized before the election. In October, the FDA published a condensed form of the guidance and the White House backed down.
The new standards meant Pfizer would not have sufficient safety data to apply for an emergency authorization until the second half of November. As cases began to surge in mid-October, Pfizer’s scientists considered simply waiting to do their first analysis at 62 cases, which would provide more confidence about the result and wouldn’t cause much of a delay.
The rapid surge of coronavirus infections in the cooler months, while devastating for the country, means the trial is rushing toward completion faster than company executives anticipated. With more people being exposed to the virus amid the surge, testing the vaccine becomes easier — and faster.
In late October, in a public meeting, the FDA’s vaccine advisory committee ridiculed the notion of reporting data on 32 cases. Soon afterward, Pfizer decided to revise its protocol to wait for 62 cases, a decision welcomed by the FDA. Pfizer temporarily stopped evaluating test samples from participants while officials discussed the case-count issue and other complex protocol changes with the agency.
“Nobody was trying to do anything bad to anyone’s reelection,” said a senior administration official. “Everyone was wanting to do the right thing by public health.”
But Trump was furious Pfizer’s promising results came shortly after the election. In Monday’s task force meeting, hours after the Pfizer news was released, Azar said the FDA’s tougher guidelines provided an incentive for the company to wait longer to determine results; there was little upside to disclosing effectiveness data on 32 cases when the company still would have to wait for safety information before applying for emergency authorization.
Azar, who as a board member of Operation Warp Speed does not take part in the FDA’s decisions, has worked to distance himself from the FDA’s decisions with the president and top White House aides.
Hahn told the task force that Pfizer’s vaccine could be authorized soon. Azar again corrected him, saying the FDA should not overpromise given that it took the agency longer than initially expected to issue an emergency use authorization for a promising antibody treatment also announced Monday.
Given the timing of the Pfizer announcement, Trump and his allies are convinced he has been right all along about a “medical deep state,” a senior administration official said.
The president and his aides were annoyed when Pfizer’s Jansen, in responding to a question from the New York Times, distanced the company from Operation Warp Speed, according to a senior administration official who spoke on the condition of anonymity to reveal private discussions.
Pfizer did not take money from the government for research and development; instead, it spent $2 billion of its own money. It has a $1.95 billion contract with Operation Warp Speed for distribution of its vaccine assuming its candidate is successful. Pfizer spokeswoman Amy Rose said the company is working closely with Operation Warp Speed on distribution, but that Jansen was referring to Pfizer not receiving government funding for research and development.
Some Trump aides said it was probably better for vaccine confidence for the data to be released after the election.
“Honestly, from my perspective, it’s probably better that we announced anything about the vaccine after the election because it’s going to be more trusted by the American people,” said a senior White House official, who spoke on the condition of anonymity because he had not been authorized to discuss the matter. “I’m not sure Pfizer did the wrong thing.”