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.
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Califf Previews US FDA’s Authorization Rationale For COVID Bivalent Boosters
FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’
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.
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.