publication date: Feb. 12, 2021

Peter Marks: How FDA crunched COVID-19 vaccine review timelines without compromising safety or efficacy

By Alexandria Carolan

This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage is available here.

Faced with a pandemic that kills thousands of Americans each day, FDA leadership had to get therapeutics and vaccines for SARS-CoV-2 onto the market with unprecedented speed without sacrificing standards.

Rapid response and expedited regulatory science was key to stemming the tide of infections and deaths, and that approach has been successful, officials said—the COVID-19 vaccines authorized to date are both safe and efficacious and are now widely deployed, less than two months after being greenlighted.

“We noted that we had to see clear and compelling efficacy from a large and well-designed phase III clinical trial in order to consider issuing an Emergency Use Authorization,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a Feb. 4 keynote address at the American Association for Cancer Research’s virtual meeting on COVID-19 and Cancer.

“We would look carefully at the quality, safety and efficacy of those vaccines, we’d take them to the advisory committee meeting, and that we would have enhanced post-deployment surveillance.”

Marks affirmed that COVID-19 vaccines authorized via the agency’s Emergency Use Authorization pathway are safe and efficacious—and said that other vaccines are in the pipeline.

Two mRNA vaccines, sponsored by Pfizer/BioNTech and Moderna, received EUA designation in December.

“Obviously, we want to see Biologics License Applications for these vaccines, and in fact, we are requiring the sponsors of these vaccines to do so. But to get … Continue reading Peter Marks: How FDA crunched COVID-19 vaccine review timelines without compromising safety or efficacy

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