FDA scientists' analysis of J&J COVID-19 booster data raises red flags
The Peninsula
U.S. Food and Drug Administration scientists said on Wednesday they did not receive enough data in time to do their own analysis of Johnson & Johnson's application for a booster dose of its COVID-19 vaccine, but the agency's review of company studies raised some red flags.
Advisers to the FDA will meet on Oct. 15 to assess the risks and benefits of a booster shot of J&J's vaccine, which is currently given as a single dose.
In its review, FDA scientists repeatedly noted the limitation of small sample sizes of many of the company's studies.
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