Monovalent mRNA shots no longer authorized as boosters in people 12 and up
The FDA on Wednesday authorized bivalent COVID-19 booster shots from Pfizer/BioNTech and Moderna that target the original strain along with the Omicron BA.4/BA.5 subvariants.
In an amendment to the emergency use authorizations (EUAs), both shots can be administered starting 2 months following a primary vaccination series or prior booster — in people 12 and up for Pfizer’s shot and in people 18 and up for Moderna’s vaccine.
“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants,” Peter Marks, MD, PhD, of FDA’s Center for Biologics Evaluation and Research, said in a statement. “We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently.”
Of note, clinical data supporting the EUA amendment were derived from studies on bivalent vaccines that targeted the original Omicron strain, but the agency said it considers such data as “relevant and supportive” of the newer BA.4/BA.5-targeted vaccines.
“The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” Marks said. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness, and manufacturing quality standards for emergency use authorization.”
Monovalent mRNA vaccines that target the original SARS-CoV-2 strain will no longer be authorized as boosters in people 12 and up, the agency said.
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