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Reuters
FDA scientists’ analysis of J&J COVID-19 booster data raises red flags
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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