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# FDA Questions J&J Covid Vaccine Booster Data
- URL: https://www.fdaweb.com/fda-questions-j-j-covid-vaccine-booster-data/
- Published: 2021-10-13T12:00:00.000Z
- Updated: 2026-09-14T17:18:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150356

Although not taking a position on whether FDA should approve a booster shot for the Johnson & Johnson Covid-19 vaccine, agency reviewers are raising questions about the company’s evidence for such boosters. In a [briefing document](https://www.fda.gov/media/153037/download?ref=fdaweb.com) released in advance of a 10/15 meeting of the Vaccine and Related Biological Products Advisory Committee to consider the company’s request for booster shot authorization, agency reviewers say a test used by the company was likely not sensitive enough to accurately determine the benefit of a booster shot. They also said they didn’t have enough time to independently review much of the trial data submitted by J&J in support of its application to expand the vaccine’s emergency use authorization to include a booster shot six months after the primary shot.

Members of the advisory committee are being asked to discuss: 

- whether the J&J data support the safety and effectiveness of its Covid-19 vaccine for a booster dose at least two months after a single-dose primary vaccination; and
- whether the data support that an interval of at least six months between the primary vaccination and booster dose may result in a more robust booster response.