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:
- 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."
- 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.
- 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.
- 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.
- 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.