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‘Show Us The Data': Plan To Speed Pfizer COVID Vaccine OK In Kids Under Five Draws Questions

 
• By Sarah Karlin-Smith

Experts express cautious optimism that FDA and Pfizer have some data signaling potential efficacy for a vaccine in children under 5 despite an initial trial flop but raise concerns about the absence of public communication amid the apparent rush to an EUA. An advisory committee is scheduled for 15 February.

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FDA and Pfizer Have Offered Little Clarity On What New Data May Justify Earlier Than Expected Vax OK In Under 5 • Source: Alamy

Pfizer Inc. and BioNTech SE initiated a rolling submission of an emergency use authorization on 1 February for a two-shot version of the sponsors' COVID-19 vaccine in children under 6 months through 4 years of age following reports that the US Food and Drug Administration and other government officials had said there may be a way to move forward with an authorization in this age group despite a failed immunobridging study in the 2 to 4 cohort.

The FDA simultaneously announced it will convene its Vaccines and Related Biologics Advisory Committee

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