Relying on J&J's analyses to assess vaccine booster dose data -U.S. FDA staff

FILE PHOTO: A vial of Johnson & Johnson’s Janssen coronavirus disease (COVID-19) vaccine is seen during a vaccination event hosted by Miami – Dade County and Miami Heat, at FTX Arena in Miami, Florida, U.S., August 5, 2021. REUTERS/Marco Bello

(Reuters) – U.S. Food and Drug Administration scientists said on Wednesday they did not have time to analyze data submitted by Johnson & Johnson on a booster dose of its single-dose COVID-19 vaccine, in a rare case where the agency relied on a company’s analyses to brief its advisory panel.

An outside panel of experts will meet on Friday to discuss whether a booster dose of J&J’s vaccine is safe and effective anywhere between two months and six months after taking the original dose.

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