FDA review of Johnson & Johnson booster finds potential benefit in second dose, with limited data

Seattle Times

Food and Drug Administration scientists found potential benefit to a second dose of the Johnson & Johnson coronavirus vaccine in a data review that was released Wednesday and that depended heavily on the company’s analysis, suggesting a booster of that shot was perhaps more warranted than additional doses of other coronavirus inoculations.

From the dawn of the vaccine campaign, many experts said they believed the one-shot Johnson & Johnson regimen would ultimately require a second shot, and the documents pave the way for a panel of experts who advise the FDA to discuss Friday the timing, necessity and safety of a booster dose.

“Although not independently confirmed by FDA from datasets, summaries of the data suggest there may be a benefit in a second dose administered approximately 2 months after the primary dose,” FDA staff wrote. Typically, the agency does its own independent review of data, but much of the data was not submitted in time, meaning large parts of the review depend on the company’s analysis.

Johnson & Johnson is seeking authorization of a booster dose at 6 months or later after the initial shot, or as early as 2 months, for people 18 and older.

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Wednesday, October 13, 2021 - 11:47am