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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...

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Double Duty At US FDA: Tidmarsh Will Temporarily Lead Both CDER And CBER

 
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UK Initiative Steps Up Efforts To Tackle Recruitment Bottlenecks In Dementia Trials

 
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Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
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