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.
You may also be interested in...
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 director Peter Marks also wants to work on rare disease gene therapy issues and increase hiring before the end of the year.
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.