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.
“Evidence is now available that most of the US population five years of age and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines.”
The safety and effectiveness of both vaccines are based on the FDA’s previous analyses of clinical trial data on the companies’ respective monovalent and investigational BA.1 bivalent vaccines.
This data is relevant to the current bivalent vaccines, the agency said, because they are manufactured using the same process.
“COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine,” Marks said. “The available data continues to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalisation, and death.”
The authorisations follow discussions that took place during the meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) in January. During that meeting, the committee unanimously recommended “harmonising the strain composition of COVID-19 vaccines” in the US and supported simplifying the vaccine dosing schedule.
The VRBPAC is set to meet in June to discuss the strain composition of the COVID-19 vaccines for autumn 2023, much like the FDA does yearly with influenza vaccines.