Janssen Biotech Inc.
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Latest From Janssen Biotech Inc.
J&J CEO Gorsky says the agency is working with sponsors to ensure the proper data is gathered to make the vaccine available in children.
Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.
FDA and CDC advisory committee members wonder how to use the single-shot J&J vaccine if an ongoing study shows two doses are better than one.
The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.
- Drug Delivery