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Janssen Booster Evidence Draws Questions From US FDA, But Also A Nod Towards Benefits

 
• By Derrick Gingery

Agency assessors couldn’t independently verify several Janssen analyses of booster shot data and raised concerns about small samples sizes and an unvalidated immunogenicity assay.

US COVID-19 vaccination card with Janssen
The FDA's Vaccines and Related Biological Products Advisory Committee will consider whether a Janssen COVID-19 vaccine booster should be recommended. • Source: Alamy

US Food and Drug Administration assessors do not seem opposed to authorizing a Janssen Biotech Inc. COVID-19 booster shot, but were unenthusiastic about the request and raised several questions about the data submitted.

Janssen is seeking an emergency use authorization amendment to recommend a vaccine booster to those 18 and older six months after the original shot or later, but the second shot could be given as early as two months after the first

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