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

 
• By Sue Sutter

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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The mRNA vaccines are now authorized for use as a booster dose in all adults in the US. • Source: Alamy

The US Food and Drug Administration’s emergency use authorization of the Pfizer Inc./BioNTech SE and Moderna, Inc. COVID-19 vaccine boosters for use in everyone ages 18 years and older was not based on new clinical efficacy or immunogenicity data. Instead, the authorizations relied on the same immune response data that supported the vaccines’ previous EUAs for booster doses in certain high-risk populations.

However, the FDA also took into account additional real-world data that have become available on the recently increasing number of cases of COVID-19 in the US and on the risk...

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