FDA releases high coronavirus vaccine standards despite White House resistance
Agency asks drugmakers to monitor patients for two months after final dose
The Food and Drug Administration issued long-awaited guidance Tuesday on the data it expects from drug companies seeking emergency authorization of COVID-19 vaccines, overcoming White House pressure for lower standards intended to push out vaccines quickly.
The 18-page guidance was released a day after reports suggested the White House had blocked the agency from issuing the guidelines, which are meant to engender public confidence.
One of the issues was whether the FDA would stick with its plan to require drugmakers to follow patients for two months after their final dose of a vaccine. The nonbinding FDA guidance and another agency document quietly released earlier Tuesday maintained that standard.
That would likely interfere with the White House’s push to issue an emergency authorization before Election Day on Nov. 3.
That did not sit well with President Donald Trump, who tweeted late Tuesday night: “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”
The earlier document includes a summary of advice provided to vaccine developers about an emergency use authorization. That details in an appendix the information drugmakers should include to demonstrate safety and effectiveness. Studies should include “a median follow-up duration of at least two months after completion of the full vaccination regimen,” the FDA says, among other data.
Trump has repeatedly predicted that a vaccine would be available much more rapidly than his top health officials and drug company executives have estimated. At the presidential debate in Cleveland last week, Trump said it’s possible there would be results before Nov. 1 and that “we’re going to deliver it right away.”
But Trump’s rhetoric, according to recent polls, has inspired a majority of wary Americans to predict that Trump will compel the FDA to authorize a vaccine without enough evidence that it’s safe and effective.
Top FDA officials have said they were working on guidelines for emergency authorization that would represent a higher standard than they normally would apply, given the sheer number of people who will eventually be vaccinated and the hesitancy over getting a COVID-19 vaccine.
“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement Tuesday.
The release of the guidance memo and standards follows reports in Politico and The New York Times that the White House was scuttling their public release. The FDA has said the guidelines were made clear to vaccine makers, but the public had not had a chance to view them before publication Tuesday.
Last week, the Biotechnology Innovation Organization, which represents vaccine makers, sent a letter to the administration requesting the public release of the new guidance, in part to “strengthen public confidence.”
Of the four vaccines currently in the final phase of human testing, phase 3, just one company, Pfizer, has suggested it would have enough data to submit an emergency use request to the FDA by the end of October.
At the debate, Trump cited conversations with Pfizer and other drugmakers as reasons for his confidence that a vaccine would be delivered sooner than experts expect.
Pfizer CEO Albert Bourla pushed back in a series of tweets late Tuesday morning, after Politico reported that the drug industry was working with the White House to push back on the stricter FDA requirements.
“Pfizer has never discussed [FDA’s COVID-19] vaccine guidelines with the White House and will never do so as it could undermine the agency’s independence,” he said.
Pfizer’s phase 3 trial began in late July. Participants are to take a second dose of the vaccine a month after getting the first. The trial was originally planned to enroll 30,000 participants but in September was expanded to 44,000 participants. The company estimated that 30,000 participants were enrolled by the third week of September.
It’s unclear whether Pfizer’s late October timeline for results was based on one month of patient follow-up or two. If it was two, then only participants who had enrolled by late July would have enough evaluation to be considered.
Johnson & Johnson, whose COVID-19 vaccine candidate entered phase 3 clinical trials in September, also appears to be working under the assumption that the FDA will want two months of follow-up safety data for an emergency use authorization. Unlike the other potential vaccines in phase 3, Johnson & Johnson’s product requires only one dose, meaning results might be available more quickly. But a company spokesman pointed to previous statements indicating that the company doesn’t expect to have an emergency use authorization until early 2021.
Checks on political influence
The FDA briefing document that included the new guidelines also was supplied to the Vaccines and Related Biological Products Advisory Committee, an independent group of academics that will guide FDA decisions.
Many experts concerned about political interference at FDA view the advisory committee, which conducts its meetings in public, as an important guardrail. It would be difficult to rush a vaccine for political expediency without the advisory committee sounding an alarm, these experts say.
They say the move shows the importance of the advisory committee for building public trust in a vaccine.
“The release of this information by FDA is an encouraging signal regarding its commitment to transparency and independence as it evaluates COVID vaccine candidates,” said Jason Schwartz, an expert in vaccination at the Yale School of Medicine. “VRBPAC can play an important role in supporting those efforts this fall and beyond, as today’s release of EUA guidelines demonstrates.”
In addition to the two-month follow-up period, the guidelines suggest any drugmaker seeking the authorization of vaccine should expect a public VRBPAC meeting “to discuss whether the available safety and effectiveness data support authorization of an EUA.”
The document makes clear that there should be a separate public meeting for each vaccine under consideration.
FDA Commissioner Stephen Hahn for several weeks has tried to reverse the politicization of the vaccine review process, saying any decision would be made by the agency’s career scientists without any outside influence.
“We certainly want new products to come to the market as quickly as possible to help prevent additional illnesses and deaths, but if a national vaccine campaign is going to be successful, the American public must have full trust in the FDA’s review process,” he said Tuesday in a prerecorded speech at the Food and Drug Law Institute’s annual conference.
Hahn did not address any new FDA guidance, but he said the agency “will not authorize or approve any COVID-19 vaccine before it has met the agency’s rigorous expectations for safety or effectiveness.”
“In this effort, science will guide our decisions. FDA will not permit any pressure, from anybody, to change that,” Hahn added.