US FDA Leaves Pfizer’s Efficacy Data Out Of Under 5 EUA Due To ‘Data Maturity,’ Lack of ‘Confidence’
Moderna’s ‘more mature’ vaccine efficacy data in children under 6 get agency highlight due to what Peter Marks called a ‘confidence’ difference in the numbers, the but CBER chief also said differences between Moderna’s and Pfizer’s vaccines are ‘subtle’ in this age group.
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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
CBER director Peter Marks also wants to work on rare disease gene therapy issues and increase hiring before the end of the year.
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.