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CDC’s Walensky Suggests Higher Bar May Be Needed For Fourth COVID Vaccine Shots

 
• By Sarah Karlin-Smith

Pfizer and Moderna have both indicated a fourth mRNA COVID vaccine may be needed. Companies may need to show waning protection against severe disease first.

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Vaccine makers might need to do more work to get a fourth COVID shot cleared than they did for their initial boosters. • Source: Alamy

COVID-19 vaccine sponsors may be held to higher data standards if they hope to get a fourth or additional booster shot cleared for use in the US than the companies were for the initial booster doses, Centers for Disease Control and Prevention Director Rochelle Walensky hinted 7 January. This may include showing how another shot provides added protection against severe disease.

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Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.

Updated: US FDA Commissioner Makary Was Sworn In, Knew Of Plan to Push Out Marks, Sources Say

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.

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