Same Data, Broader Use: COVID-19 mRNA Vaccine Booster Authorizations Expanded In US
Emergency use authorization for Pfizer/BioNTech, Moderna vaccine boosters for everyone ≥18 years was based on the same immune response data that supported previous clearance in certain high-risk groups, although FDA said it also considered additional real-world data on myocarditis risk and the recent increase in COVID-19 cases.
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In expanding authorization of booster doses for both mRNA vaccines, the agency updated Moderna’s fact sheet to state the vaccine appears to pose a higher risk of myocarditis/pericarditis in males under age 40 years after the second dose, although data are ‘not yet dispositive.’
Despite initial concerns among FDA staff and its advisory committee about unblinding the Comirnaty pivotal trial after emergency authorization, agency’s review of the first COVID vaccine to receive full licensure suggests its safety conclusions were not adversely affected.
With an EUA submission for its Paxlovid treatment pill and expected authorization for universal adult vaccine boosters, Pfizer is establishing a portfolio of COVID products that could be used well after the eventual lifting of the public health emergency.