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 final quality control checks. It said it has the capacity to ship up to 15 million doses by 9 September

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