FDA simplifies use of Moderna and Pfizer/BioNTech’s bivalent COVID-19 vaccines

FDA simplifies use of Moderna and Pfizer

The vaccines are now authorised for all doses in individuals aged six months and older.

Emergency use authorisations for both Moderna and Pfizer/BioNTech’s bivalent mRNA COVID-19 vaccines have been amended by the US Food and Drug Administration (FDA) to simplify the vaccination schedule for most individuals.

The current bivalent vaccines, targeting the original and omicron BA.4/BA.5 strains, can now be used for all doses administered to individuals aged six months and older, including for an additional dose or doses for certain populations.

Each vaccine now has one fact sheet for healthcare providers and one for recipients and caregivers, rather than different fact sheets for the various authorised age groups.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: “At this stage of the pandemic, data supports simplifying the use of the authorised mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination.