White House cited drug companies’ objections in overruling FDA’s vaccine standards
October 6, 2020
Of the four companies with vaccines in final-stage trials, only Pfizer believes it may know whether its candidate is safe and effective before the election – a finding that could put the company well ahead in the lucrative race to be first to market, and match up with Trump’s preferred timeline.
But if it were held to the tougher guidelines sought by the FDA, Pfizer would need to track its vaccine trial participants for a median of two months after receiving their final dose to qualify for an emergency authorization, in addition to passing a series of other more thorough safety and efficacy tests.
The company began its trial in July and took roughly a month to enroll half the necessary participants. Those people would not get their final shot until three to four weeks later, putting them well into September. Tacking on another two months from there makes it appear unlikely Pfizer would have enough data to evaluate its vaccine until after the election.
“The chance of this happening before Nov. 3 is getting lower,” Eric Topol, director of the Scripps Research Translational Institute, said of an emergency authorization under that standard. “And it was already slim.”
Pfizer spokesperson Sharon Castillo told POLITICO that the company speaks regularly with Trump and other White House officials about health policy issues including its work on a Covid-19 vaccine.
She declined to provide specifics of Pfizer’s conversations with Trump, but said the company has not voiced objections to the FDA’s plan for more stringent guidelines, and has pledged publicly to abide by the standards the agency sets out.
“When it comes to developing and testing our vaccine candidate, there are only two considerations guiding our work, and that is safety and efficacy,” Castillo said, characterizing Pfizer’s communications with the White House as standard check-ins “that were happening before Covid, are happening during Covid and will continue to happen after Covid.”
Moderna and Johnson & Johnson, the two other companies Trump said last week he had spoken with, did not respond to requests for comment.
AstraZeneca – which is also in final-stage trials – did not address questions about whether it had spoken with Trump, saying only that it “is committed to working with governments and key partners to ensure we develop and gain regulatory approval for an effective vaccine as quickly as possible.”
The White House’s references to private-sector pushback have in the meantime puzzled FDA officials, who say the agency itself never came under similar pressure from vaccine developers.
In fact, a memo on the revised guidelines that the FDA presented to health secretary Alex Azar just prior to sending them to the White House included a prediction that new standards would be “widely welcomed” by the industry, two people with knowledge of the document said.
White House officials have not specified to the FDA which companies or groups raised concerns. And in the past week, executives from Johnson & Johnson and Merck, as well as the trade group BIO expressed support for publishing the updated requirements.
“The release of the FDA guidance would provide scientists and researchers greater regulatory clarity and strengthen public confidence in any future vaccine that may be authorized or approved,” BIO CEO Michelle McMurry-Heath wrote Azar in an Oct. 1 letter on behalf of the group’s members, which include every company involved in the vaccine race except AstraZeneca.
Those developments have spurred competing theories within the FDA, with some officials now suspecting the White House is exaggerating the level of industry opposition to justify vetoing release of guidelines that might undercut Trump’s campaign message that the pandemic is close to being over.
Others wondered whether the pharmaceutical industry did indeed lobby the White House, and is only now expressing support to distance itself from the politicization of standards that the FDA insists it will enforce anyway.
“The companies know what we’re expecting,” Peter Marks, who heads the FDA office overseeing vaccine approvals, said Sept. 30 of the agency’s revised guidelines. “The guidance was trying to explain that, explain what we expected and to reassure the public.”
The industry’s public backing has nevertheless bolstered the FDA’s resolve to disseminate the guidelines viewed by some in the agency as crucial to its credibility, even if it means inviting yet another showdown with Trump and his top aides.
In recent days, FDA officials went as far as to discuss how they could effectively publicize the standards without official approval from the White House, a senior administration official said, through a combination of direct conversations with vaccine developers and information posted strategically to the FDA’s website.
“The goal is to get all the information out in its totality,” the official said. “So what remains to be seen is whether that’s going to infuriate the White House.”