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.”
