FDA’s vaccines and biologics chief talks Covid-19, 2022 priorities, and getting back to gene, cell therapy review

WASHINGTON — No part of the Food and Drug Administration has been challenged by the pandemic quite like the Center for Biologics Evaluation and Research and its Office of Vaccines Research and Review.

Now that center, which put some of its work on hold to review Covid-19 vaccine applications at record speed, is facing a new challenge: getting back to normal.

“[2022] will have to be a year where we transition to working alongside the pandemic, as opposed to being dominated by the pandemic,” Peter Marks, the director of CBER, told STAT in a wide-ranging interview.

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