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Same Data, Broader Use: COVID-19 mRNA Vaccine Booster Authorizations Expanded In US

Executive Summary

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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