FDA Vaccine Rules Challenged as Weak at Advisory Panel Meeting
- Panel made up of health specialists who aren’t federal workers
- FDA says those on placebo shouldn’t be told if shot works
The U.S. Food and Drug Administration headquarters in Maryland, U.S., on Aug. 25.
Photographer: Stefani Reynolds/BloombergThis article is for subscribers only.
U.S. vaccine advisers questioned whether safety and efficacy standards set by Food and Drug Administration officials were high enough to warrant emergency authorization of a shot.
About two dozen outside advisers to the FDA with expertise in infectious diseases met Thursday to weigh in on agency standards that require a vaccine to work in at least 50% of people and for drugmakers to collect two months of safety data on at least half of clinical trial volunteers.