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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Influenza vaccine strain change process could provide framework to update composition of COVID-19 vaccines, agency says. Advisory committee to discuss when changes could be supported by manufacturing information alone, and timing and populations for use of additional boosters.
US FDA advisory committee will meet in April to discuss whether and when boosters may be needed and for whom; Moderna seeks authorization for second booster dose in everyone ≥18 years, while Pfizer/BioNTech have limited their request to individuals ≥65 years.
Confirmation hearing comment suggests FDA Commissioner nominee Robert Califf thinks an overwhelming advisory committee vote should give agency officials pause.