J&J's booster data: 5 takeaways

Johnson & Johnson submitted data from four clinical trials to the FDA to demonstrate the safety and efficacy of its COVID-19 booster shot, but the agency was unable to verify most of it, according to briefing documents published Oct. 13.

Five details:

  1. The FDA said Johnson & Johnson's datasets were not submitted in sufficient time for the agency to conduct an independent review. The agency said its assessment "is based on a review of sponsor-generated analyses that FDA determined to be most relevant to the request for use of a booster dose."

  2. The agency said summaries of Johnson & Johnson's data suggest people who received its single-shot vaccine could benefit from a second dose administered about two months after the first dose.

  3. The sample size Johnson & Johnson provided for people ages 60 and older "limits the ability to conclude about an increase in efficacy after the second dose in this group," according to the documents.

  4. The small number of cases confirmed to be caused by the delta variant also prevented the FDA from coming to a conclusion about the booster's efficacy against the variant, according to the documents.

  5. The documents are meant to brief the FDA's Vaccines and Related Biological Products Advisory Committee, which will meet Oct. 15 to discuss amending the emergency use authorization of Johnson & Johnson’s COVID-19 vaccine for the administration of a booster dose in people ages 18 and older.

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