The U.S. Food and Drug Administration (FDA) this week authorized updated COVID boosters from Pfizer
The new vaccines protect against both the original SARS-CoV-2 strain of the coronavirus and the highly transmissible mutant Omicron BA. 4 and BA.5 subvariants that are the current dominant strains circulating globally. This dual-virus targeting shot is called a bivalent vaccine.
This is the first time the FDA has authorized an updated vaccine formula to combat COVID-19 since the original shots were granted emergency use authorizations in late 2020. Public health officials are hoping the updated vaccines will help protect against another potential wave of infections this fall and winter.
"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. ... We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a statement. "the FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations."
The updated Moderna vaccine is authorized for use as a single booster dose in adults, while the PFizer-BioNTech shot is cleared for use in people 12 years and older. Individuals are eligible for the new boosters at least two months after completing their initial two-dose primary series or their last booster shot.
The U.S. Centers for Disease Control and Prevention (CDC) still needs to sign off on the shots before nationwide pharmacies can begin distribution. The CDC's independent advisory committee met on Thursday and Friday to review the data and is expected to issue a recommendation early this weekend.
Under the new authorization, the U.S. will no long use original vaccines as booster doses for individuals ages 12 and older.
Nearly 76% of Americans ages 12 and older have received their primary series of vaccines, according to CDC data. About 50% of those in that same age range have also received at least one booster dose.
