Pfizer’s COVID-19 Vaccine Data In Young Children Could Place US FDA In Awkward Position Again
The agency is considering how to move forward as Pfizer studies a third shot after missing an efficacy endpoint in children age 2 to 5.
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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.
The company could reach $100bn in revenues in 2022 for the first time, powered by Comirnaty and Paxlovid; actual sales for the COVID-19 products are likely to go higher based on supply contracts.
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.