FDA regulators seek advice on thorny issues as vaccines near

WASHINGTON (AP) — Scientific advisers told U.S. regulators Thursday they’re concerned that allowing emergency use of a COVID-19 vaccine could damage confidence in the shots and make it harder to ever find out how well they really work.

The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the coronavirus. Facing growing public fears that politics may override science, the FDA took the unusual step of assembling more than a dozen independent scientists to review if its standards are high enough to judge the shots.

The panelists generally supported guidelines for the vaccines that the FDA recently issued, over White House objections. Those guidelines define exact safety and effectiveness criteria that will be required if companies seek special permission to use their vaccines before massive final studies are complete.

While they were divided on some of the details, the advisers said it’s critical those tests are finished — especially since a vaccine offered early by definition is still experimental and may come with little evidence of how well it protects some of the people at highest risk, including older adults and minorities...

FDA’s Dr. Doran Fink agreed the agency’s approach will be a balancing act between gathering the strongest data to tell if the shots are safe and effective for at least some Americans while also “being able to make an impact on the pandemic in as reasonable an amount of time as possible.” ...

Also see: FDA advisory committee debates safety and efficacy standards for a coronavirus vaccine

https://www.washingtonpost.com/health/2020/10/22/covid-vaccine-safety-effectiveness-guidelines/