COVID-19 Vaccine Boosters Targeting Omicron BA.4/BA.5 To Launch As Clinical Trials Continue

Pfizer/BioNtech’s and Moderna’s updated bivalent Omicron booster doses will be available in coming days. Pfizer/BioNtech has an ongoing study in individuals 12 and older and are preparing EUA application for those 6 months and older. Moderna completed enrollment of 512 participants in a Phase 2/3 trial.

COVID-19 vaccine booster
US FDA authorizes COVID-19 vaccine boosters targeting Omicron variants • Source: Shutterstock

The US Food and Drug Administration initiated a new phase in the battle against COVID-19 with the emergency use authorization of Pfizer Inc./BioNTech SE and Moderna, Inc. Omicron BA.4/BA.5 bivalent booster vaccines. At the same time, the agency ended authorization of the monovalent mRNA COVID-19 vaccines as booster doses for individuals 12 years of age and older.

Pfizer/BioNTech said its updated, bivalent vaccine, authorized for individuals 12 years of age and older, will be shipped immediately, following...

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