“I think we should have it before the election, but frankly the politics gets involved,” Trump said this week, expressing frustration over the FDA’s emergency authorization process. “They want to play their game.”
It’s against that backdrop that Pfizer is attempting to convince top health experts that it’s not skimping on safety — and that its record-fast progress developing a vaccine has been driven purely by science, rather than a desire to deliver on Trump’s demands.
Bourla and the drug maker’s top scientists met last week with Eric Topol, a well-known cardiologist and public health expert who has criticized the company’s vaccine plans in op-eds and on Twitter. Pfizer has also set up a one-on-one briefing between Bourla and Ezekiel Emanuel, an adviser to Joe Biden, after he organized a widely circulated letter urging the company to hold off on seeking any vaccine authorization until “at least late November.”
“They want to have the medical community be supportive of their program,” Topol said of Pfizer’s efforts. “They could’ve just written me off, but they actually reached out, and I give them credit for that.”
In addition to working behind the scenes to shore up alliances in the public health community, Pfizer has gone to lengths publicly to distance itself from the presidential race — branding its efforts as moving solely at the “speed of science” and insisting it won’t be influenced by competing political pressures to rush a vaccine before the election, or delay it until afterward.
“Now, we are approaching our goal and despite not having any political considerations with our pre-announced date, we find ourselves in the crucible of the U.S. Presidential election,” Bourla wrote in a memo to staff this month. “We would never succumb to political pressure.”
Yet the company has also resisted calls to admit there’s too little time to secure an official authorization before Election Day. Pfizer remains in close communication with the White House about its progress toward a Covid-19 vaccine.
Bourla in recent weeks has spoken directly with Trump, who has consistently urged drug makers to move faster in their race toward a viable vaccine, administration officials said.
And on Wall Street, analysts closely monitoring Pfizer’s progress widely believe the structure of its clinical trials will inevitably lead to a late October announcement that it’s found a working vaccine.
“The moment that data is processed and reported to management, they basically have to put out a press release, irrespective of politics,” said Umer Raffat, an analyst at investment bank Evercore ISI.
Pfizer spokesperson Sharon Castillo downplayed the company’s efforts to head off criticism, calling its meetings with scientists a standard practice.
“This is not something out of the ordinary,” she told POLITICO.
Emanuel and Topol penned a letter last month with more than 60 other scientists voicing concerns about Pfizer’s ambitious vaccine plan. They want the drug company to stick to standards that could slow down a regulatory filing but provide vital information about how safe and effective the shot is across a range of people.
The company has stood apart from its competitors for months on the vaccine strategy. Pfizer is one of the only top contenders in the U.S. vaccine race not to accept federal funds for research and development. Instead, it signed a $1.9 billion deal to deliver 600 million doses of its shot, including 100 million by the end of this year.
Pfizer also formed its own board of outside experts to review the vaccine’s safety and effectiveness, opting out of a group effort assembled by the National Institutes of Health that includes other major vaccine contenders Johnson & Johnson, Moderna and AstraZeneca.
The FDA’s stricter standards for emergency authorization of any vaccine — released this week — dictate that drugmakers hold off applying until they have two months of post-vaccination data on at least half of participants in their final stage of clinical testing. Each company’s Phase III trial must include at least 30,000 people, and most of the studies are still enrolling participants.
Emanuel is worried that Pfizer will seek to undercut those FDA standards in its quest to be the first company to bring a vaccine to market.
“I want them to adhere to what we asked for in the letter — which is minimum two months’ safety data,” said Emanuel, who was scheduled to speak with Bourla on Friday. “It seems to be if you are going to ask hundreds of millions of people to take your vaccines, two months’ safety data is not too much to ask.”
To hit that target in the next few weeks, Pfizer would need to have administered second doses to at least half of its Phase III trial participants before Sept. 3. But just 6,000 people received their second shot by Sept. 4.
On top of that, the drugmaker and its partner BioNTech decided last month to bump the enrollment of their Phase III trial from 30,000 people to 44,000. It’s not clear whether FDA will accept data from the first 15,000 people, or will now want information on 22,000 participants before Pfizer files for emergency authorization.
“I think it was a wise move by the FDA to put [the guidance] out there because there has been a lot of saber-rattling from the administration,” said Paul Offit, a University of Pennsylvania vaccine expert who sits on an FDA panel that will meet Oct. 22 to discuss what the agency should expect from coronavirus vaccine candidates.
Pfizer does not expect to have new data to share before the Oct. 22 discussion, Castillo said. But the company is scheduled to release its quarterly earnings on Oct. 27, raising the prospect that it will release promising vaccine data as part of that report, just one week out from Election Day. Even then, Pfizer would still have to file an application and the FDA would need to host an advisory committee meeting before authorizing a vaccine.
The agency “is prepared to promptly schedule meetings” of its expert advisory panel for any impending emergency use or approval requests, a spokesperson said.
But any glimmer of positive news from Pfizer in the coming weeks could still pit the White House against the FDA, in the wake of their recent showdown over what standards a Covid-19 vaccine should have to meet to pass muster.
That two-week dispute over the FDA’s more stringent benchmarks ended only after the agency unilaterally included them in briefing documents prepared for the Oct. 22 advisory committee. The White House, which had previously raised a range of objections, abruptly endorsed the requirements hours later.
The reversal stunned many within the FDA who assumed the guidelines would never be officially cleared, because publishing them would make it obvious a vaccine before the election is nearly impossible. In addition to mandating at least two months of post-vaccination data to gauge a vaccine’s safety, the agency says that companies should only apply for authorization after they have have observed five cases of severe illness in their trial’s placebo group — to judge whether the shot actually protected people.
Health experts say those two provisions will push the earliest vaccine authorizations well into November. But the FDA guidelines do not carry the force of law, and could still be overridden by a president eager to claim vaccine success.
The agency’s release of the vaccine standards appeared to shock Trump, who later targeted Hahn in a tweet complaining that the policy would “make it more difficult for them to speed up vaccines for approval for Election Day.”
The episode boosted the agency’s credibility as the ultimate arbiter of a Covid-19 vaccine. But Trump’s rebuke also served as a warning shot that the FDA could still come under intense pressure in the final weeks of the month, officials said.
While there is broad confidence Hahn would resist efforts to speed a vaccine for political reasons, the White House could still try to enlist Health Secretary Alex Azar, who retains ultimate authority over the authorization process.
“It’s the third time that the president has called out Hahn directly since the FDA commissioner arrived just 10 months ago,” a senior administration official said. “What I see is Hahn going crosswise quickly with the president.”
The agency does not typically release advisory meeting materials two weeks in advance, making the stringent expectations slipped into the Oct. 6 documents all the more noticeable.
“Given the importance of Covid-19, we posted the meeting materials as soon as possible to facilitate a robust discussion,” an FDA spokesperson said.
Azar has also insisted repeatedly that any vaccine must go through FDA’s “gold standard” evaluation process.
Still, health experts said even the slim chance that Pfizer could announce its vaccine works in the next few weeks keeps the door open for Trump to intervene. Across a more than hourlong briefing with Pfizer’s vaccine team and senior executives, Topol said the company refused to say whether it would seek an authorization before Nov. 3.
“Bourla would be playing into the hands of the politics” if he did so, Topol said, adding that the company’s presentation left him more confident in its development process but not completely satisfied. “He really should’ve been quiet all along about this. He should’ve never been talking about October.”
And despite Pfizer’s increasingly public efforts to rise above the political fray, officials both inside and outside the administration expressed deep skepticism of its contention that the company is steering well clear of the competing pressures coming out of Washington.
“The tweets make you think one thing,” a senior administration official said of Bourla’s recent denials that Pfizer ever discussed the FDA’s vaccine requirements with the White House, despite his direct line to Trump. “To me, it’s a misleading statement.”
FDA’s signal this week that it would hold vaccine makers to a high standard — despite Trump’s protests about political delays — has scientists convinced the agency may be the last bulwark against an October surprise that dissolves any remaining public confidence in a Covid-19 shot.
“On the one hand there are hundreds of people dying every day. On the other hand, most of the vaccines are going to be given to healthy people who are unlikely to die….we only get one chance for a first impression,” said Offit. “If we put something out there that is less effective or less safe, we are going to be making a terrible mistake.”