- President Donald Trump on Wednesday said the White House "may or may not" sign off on the Food and Drug Administration's plans to spell out specific standards for granting an emergency authorization of a coronavirus vaccine, suggesting without basis that the agency's efforts to do so are politically motivated.
- Trump has repeatedly hinted a vaccine could be authorized by the agency before the presidential election, even as some government officials, including the head of the U.S.' vaccine program, say that's unlikely. The FDA's forthcoming guidance reportedly contains criteria that would be difficult for a drugmaker to meet by Nov. 3.
- Emergency authorizations, or EUAs, typically require less clinical data than a standard drug approval. Given the potential significance of a coronavirus vaccine and the potential for widespread use among healthy individuals, however, the FDA has signaled any authorization for a vaccine would be an "EUA plus," with stricter requirements.
Trump's comments came hours after FDA Commissioner Stephen Hahn pledged to lawmakers in a Senate hearing that politics would not "play any part" in any agency decision to authorize or approve a coronavirus vaccine.
The FDA has already set out its standards for granting a full vaccine approval, issuing guidance to developers in late June. Concerns have grown, however, that an EUA for an experimental shot might be granted before there's enough data from the large Phase 3 trials now ongoing. FDA authorizations for the malaria pill hydroxychloroquine and, more recently, convalescent plasma were both controversial and spurred questions of political interference in the agency's review process.
The forthcoming guidance on vaccine authorizations is therefore meant to bolster confidence in the FDA's standards and decision making. According to reports by The Washington Post and The Wall Street Journal, the draft guidance would require a median of two months of follow-up after trial participants' final shot, and hold developers to a similar standard of 50% vaccine effectiveness that was set out in the June guidelines for approvals.
The guidance would also reportedly require several cases of severe COVID-19, as well as cases in older adults, to more fully judge a vaccine's potential before a full approval review is conducted.
Asked about the reports on Wednesday, Trump said the guidance "sounds like a political move," adding that the White House would weigh in on the FDA's plans.
"We're looking at that, and that has to be approved by the White House. We may or may not approve it," he said.
The FDA submitted the guidance to the U.S. Department of Health and Human Services, its parent agency, last week. The White House Office of Management and Budget is also reviewing the document, according to The Wall Street Journal.
"[T]he agency intends to issue additional guidance shortly to provide sponsors of requests for Emergency Use Authorization for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA," an FDA spokesperson said to BioPharma Dive in a statement.
Pfizer and Moderna are currently the closest to obtaining early data from a late-stage vaccine trial. Pfizer CEO Albert Bourla has said the company expects to have results from its study by late October, while Moderna's chief executive indicated its trial would take a little longer to yield data, likely not until November.
Pfizer's study has enrolled faster, and its design means investigators count COVID-19 cases among trial volunteers sooner than researchers running Moderna's study.
Both trials include provisions for early data checks, potentially enabling either company to declare success or failure before their study reaches the point when the principal analysis would be conducted. For each, roughly 150 cases among the expected 30,000 participants would be needed to determine vaccine efficacy.
The FDA plans to convene an advisory panel of outside experts on Oct. 22 to help it evaluate the leading vaccine candidates.
Recently, as concerns of political interference have intensified, the FDA has received support from former agency heads, who have publicly backed Hahn and the career scientists who would be making decisions on a vaccine authorization or approval.
"The standards FDA is reportedly considering for a Covid vaccine EUA represent appropriate balance between speed and safety in a crisis," wrote Scott Gottlieb, Trump's first FDA Commissioner, in a tweet on Thursday.
"Any political effort to shortcut process or degrade reasonable standards will be Pyrrhic victory if people lack confidence in a vaccine," he added.