On Thursday the U.S. Food and Drug Administration (FDA) will meet to discuss Pfizer and BioNTech’s emergency use authorization application for its coronavirus vaccine candidate.
The companies were the first to submit their application for EUA to the FDA, with Moderna following suit shortly after.
The meeting will include members of the FDA’s Center for Biologics Evaluation and Research advisory committee, outside vaccine experts and Pfizer representatives and will begin at approximately 9 a.m., with opening remarks and introductions, according to a draft agenda published by the regulatory agency. Next will be a presentation on emergency use authorization, followed by an update on epidemiology and a question-and-answer session.
Dr. Nancy Messonnier, director for the National Center for Immunization and Respiratory Disease and a senior official on the Centers for Disease Control and Prevention (CDC) task force, will then lead a discussion on vaccine safety and effectiveness monitoring, which will precede a presentation on operational distribution plans. Messonnier played a pivotal role in the CDC’s early coronavirus response press conferences.
Before breaking for lunch, the committee will discuss “considerations for placebo-controlled trial design if an unlicensed vaccine becomes available,” and will return for an open public hearing. There will then be a sponsor presentation led by Pfizer representatives before an FDA presentation and voting questions.
The committee then will take a short break before reconvening for more discussion before holding a vote on the EUA application. Based on documents published ahead of tomorrow’s all-day data review, it appears as though the panel is poised to approve the vaccine for EUA. In documents that were published on Tuesday, the FDA said it found no new concerns regarding the vaccine, and that it had met all EUA requirements.
However, even if the committee votes in favor of EUA, the decision is not final, as it will still have to be reviewed by the Center for Biologics Evaluation and Research officials. The same was true when a CDC panel voted to distribute the eventual vaccine candidate to health care workers and long-term care residents first. That decision also faced a final decision, which was later made by CDC Director Dr. Robert Redfield.
It is not clear when the FDA officials will issue their decision. FDA Commissioner Stephen Hahn previously told NPR that the final decision will depend on how Thursday’s review goes.
“A lot of what this depends upon is what the discussion is like [with] these outside experts from the vaccine advisory committee,” he told the news outlet. “If they have substantial questions or additional analyses that they think are relevant to our decision-making, we will judge whether that’s important to do. That may need to be done and that may contribute to some additional time needed. But again, I can’t prejudge what that conversation is going to be like.”