Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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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.
Agency questions clinical significance of change in primary efficacy endpoint measured in one study and raises doubts about numerous exploratory analyses for a second study aimed at explaining why Alzheimer’s patient subgroup appeared to derive less benefit than other types of dementia patients.
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.