1. Pink Sheet

COVID-19 Vaccines In Five And Younger Could Get Earlier FDA Advisory Committee Review

 
• By Brenda Sandburg

Peter Marks says agency will proceed to meeting once Pfizer and/or Moderna complete their submissions and that the two may be considered at the same VRBPAC panel. FDA's effectiveness standard has not changed, CBER director says, but acknowledges that vaccines might be a little less effective than 50% in subpopulations.

pediatric vaccine
FDA may complete review of mRNA vaccines for children five years and younger by June • Source: Shutterstock

Amidst cries from Congress and the public to act more quickly to authorize COVID-19 vaccines in children under the age of five, the US Food and Drug Administration is ready to move up tentatively scheduled dates for its Vaccines and Related Biological Products Advisory Committee to consider authorization of Pfizer Inc./BioNTech SE and Moderna, Inc.’s vaccines in the youngest populations as soon as it receives their complete submissions.

“I fully expect that we’ll have the data in June or by June ready for review” and whichever of these...

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