‘Show Us The Data': Plan To Speed Pfizer COVID Vaccine OK In Kids Under Five Draws Questions
Experts express cautious optimism that FDA and Pfizer have some data signaling potential efficacy for a vaccine in children under 5 despite an initial trial flop but raise concerns about the absence of public communication amid the apparent rush to an EUA. An advisory committee is scheduled for 15 February.
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But CBER Director Peter Marks reiterated to Senators that EUAs cannot be granted for those children until applications are completed and submitted.
FDA praised for pulling back on plans to host 15 February advisory committee review of Pfizer’s COVID-19 vaccine in children but faulted, along with other parts of US government, for raising expectations this month that the vaccine might be available for this population imminently.
Unlike the current EUA fact sheet, Spikevax’s approved labeling does not state that the vaccine may pose an increased risk of myocarditis ‘relative to other authorized or approved mRNA COVID-19 vaccines.’ Approval brings Moderna a priority review voucher, as did Comirnaty’s approval for BLA sponsor BioNTech.