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Advisors Push for More Data

Some experts pushed during a meeting of the US Food and Drug Administration vaccine advisory board yesterday for the agency to require more safety data from SARS-CoV-2 vaccine trials, the New York Times reports.

The meeting, which included infectious disease, vaccine, and biostatistics experts, focused on how the agency should evaluate candidate vaccines, the Times says. Through the meeting FDA hoped, in part, to quell worries that the agency was being pushed to approve a vaccine too quickly as well as boost the agency's credibility, as the Wall Street Journal notes.

While FDA recently adopted stricter guidelines for seeking emergency authorization for a coronavirus vaccine, some experts expressed concerns that even that two-month requirement would not provide enough data on how long the vaccine provides protection or its potential side effects.

The committee also floated the possibility of, rather than providing emergency approval of a vaccine, they might instead consider allowing expanded access to a vaccine. As the Times notes, some vaccine developers have noted that if a vaccine receives emergency approval, they would be ethically bound to provide that vaccine to everyone in their trial, even those in the placebo arm. But that, the Times says, could endanger the broader trial results.

"We are concerned about the risk that use of a vaccine under an EUA would interfere with long-term assessment of safety and efficacy in ongoing trials and potentially even jeopardize product approval," Marion Gruber, director of the FDA's office of vaccines research and review said during the meeting, according to Stat News. "And not only the first vaccine, but maybe even follow-on vaccines."