Moderna, Pfizer Nab Unanimous Votes For Pediatric COVID Vaccines But Advisors Hint At Moderna Dosing Advantage
US FDA advisory committee members raised some concerns regarding Pfizer’s three-dose schedule for children under five, suggesting Moderna’s two-dose primary series may be preferred.
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COVID Vaccines In Young Children: FDA, Sponsors Estimated Benefits Against Unclear Myocarditis Risk
US FDA estimated the three-dose primary series of Pfizer/BioNTech’s vaccine would prevent 364 hospitalizations, while Moderna estimated that a two-dose primary series of mRNA-1273 would prevent 248 hospitalizations and 60 ICU stays.
CBER’s Goal To Reach Normal Ops In 2023 Includes Clearing IND, Meeting Backlogs In 2022
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Pfizer/BioNTech Vaccine Trial In Young Kids Marked By High Level Of Unblinding
The unblinding process began months before a third dose was added to the study in the 6 months-4 years group. Consequently, only about one-third of vaccine recipients in each age cohort received three doses of BNT162b2.