COVID Vaccines For 5 and Under: Pfizer Pivot To 3 Shots Leaves Meager Data Package Compared To Moderna
Pfizer’s decision to add a third shot to the primary vaccination series for children under five means it didn’t hit FDA’s goal of a median follow-up of two months post-vaccination – at least with blinded data – and the sponsor could only do a preliminary descriptive efficacy analysis since the study had not hit the protocol-specified number of COVID cases.
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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.
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.
US FDA advisory committee members debate how a third dose, or booster, of the COVID vaccine should fit into the mix of an EUA expansion for the 12-17 and 6-11 groups; Moderna expects to have immunogenicity and safety data on booster doses in both of age groups by mid-July.