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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.

The U.S. Food and Drug Administration headquarters in Maryland, U.S., on Aug. 25.

Photographer: Stefani Reynolds/Bloomberg

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.