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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."

The Scan

UK Moves to Allow Sale of Gene-Edited Food

The UK is moving ahead to allow the sale of gene-edited food in England, Scotland, and Wales, according to New Scientist.

Questions for the Field

Stat News writes that the alleged Buffalo shooter's citation of genetics research raises questions about what the field can do.

Cell Studies on Tumor Evolution in Mouse Model of Lung Cancer, Stereo-seq, Bacteriophage Responses

In Cell this week: tumor evolution tracked in mouse model of lung cancer, organogenesis mapped using Stereo-seq, and more.

Taking Stock of the Stockpile

The US and European countries are evaluating their smallpox vaccine stockpiles as the number of monkeypox cases increases, the Washington Post reports.