The following article originally appeared in FiercePharma and was written by Eric Sagonowsky
A weeks-long feud between the White House and FDA over COVID-19 vaccine guidelines took another turn Tuesday as the agency released vaccine recommendations despite efforts by the White House to keep them under wraps. The FDA advises two months of monitoring after patients’ final doses, which could thwart President Donald Trump’s desire for a shot before the election.
As COVID-19 vaccines move closer to potential reviews at the FDA, experts with the agency last month prepared to publish a stricter set of guidelines calling for two months of data monitoring after patients received their final vaccine doses.
After the FDA released its new guidelines Tuesday, the White House agreed, meaning a shot likely won’t be available until after the election, the Wall Street Journal reports.
President Trump has repeatedly said vaccines could be available within weeks—an assessment the stricter guidelines would contradict—and the White House had sought to block the agency’s publishing them, according to reports from Politico and the New York Times.
In pushing back against the FDA, White House officials cited concerns raised by vaccine developers, Politico reports. But former FDA commissioner Scott Gottlieb, who’s now a board member at frontrunner Pfizer, said he’s not aware of any such objections.
In recent months, Trump has said a COVID-19 vaccine could be available by Election Day. But as the weeks have passed, only Pfizer could possibly be in a position to pursue an emergency use authorization by then. The company has said it expects initial efficacy results from its phase 3 trial in late October.
A spokeswoman for the company told Politico that Pfizer speaks regularly with Trump and other officials, but that the drugmaker hasn’t objected to the FDA’s stricter guidelines. Only two considerations—safety and efficacy—are guiding the company’s work, she said. Pfizer CEO Albert Bourla has written that he’s “disappointed” about politics entering the research process.
The central issue in the FDA’s tougher guidelines is whether the agency will require two months of safety data after patients receive their final vaccine doses. Moderna has agreed to wait until late November at the earliest to follow that standard, its CEO told Financial Times last week. If Pfizer were to do the same, the company wouldn’t be able to submit data until after the November 3 election, according to the reports.
Separately, an outside group of experts has urged Pfizer to hold off on its vaccine until later in November so the company can review two months of data.
On Tuesday, instead of publishing the guidelines through the White House’s process, the FDA went another route. In briefing materials for the agency’s October 22 meeting of independent experts, an appendix describes a summary of advice the FDA has given individual vaccine developers. For emergency authorizations, the agency has recommended phase 3 data with “a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the document says.
The FDA also plans to convene a separate committee meeting to review data for for each potential emergency vaccine authorization, according to the document.
The regulator submitted its tougher guidelines to the White House more than two weeks ago, but they were held up by concerns of Chief of Staff Mark Meadows, NYT reports. Meadows questioned the need for two months of safety data and argued the new guidelines would change the rules late in the game, a source told the newspaper. Further, Meadows asserted that FDA commissioner Stephen Hahn was being overly influenced by the agency’s career scientists.
On Sept. 23, Trump said the White House “may or may not approve” the guidelines, telling reporters they were “a political move more than anything else.”
For his part, Hahn sought to alleviate concerns about politics affecting vaccine reviews Monday. At a virtual interview for a medtech conference, he said career scientists at the Center for Biologics Evaluation and Research, the organization within the FDA that regulates vaccines, will have the authority to “make the assessment around safety, effectiveness, [and] quality manufacturing.”
The FDA has “processes in place to make sure that the centers are protected from any outside pressure, and that they’re focused solely on looking at the science and the data,” he said during the interview, adding, “I have absolute faith and confidence in those decisions.”
But Hahn’s ability to resist political pressure has come under scrutiny at times during the pandemic. When the FDA issued an emergency authorization for convalescent plasma, he falsely said the treatment was associated with a “35% improvement in survival.” He later walked the claim back. When Trump accused the FDA of harboring “deep state” employees, Hahn “remained silent,” lawmakers wrote in an August letter to the commissioner.
A recent Axios-Ipsos poll found that 57% of Americans have some degree of trust in the FDA.