FDA authorizes updated COVID-19 booster shots targeting omicron variant

The U.S. Food and Drug Administration (FDA) announced Wednesday that it has authorized updated coronavirus booster shots targeting the highly-contagious omicron variant.

“Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination,” it said in a statement.

The new shots, which the FDA is referring to as “updated boosters,” contain “two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.”

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“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” FDA Commissioner Robert Califf said in a statement. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”

The FDA says the updated Moderna single dosage boosters are authorized for individuals 18 years or older, while the Pfizer-BioNTech one is for individuals 12 years or older.

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Both kinds of booster shots will provide “better protection against COVID-19 caused by the omicron variant,” it added.

“The BA.4 and BA.5 lineages of the omicron variant are currently causing most cases of COVID-19 in the U.S. and are predicted to circulate this fall and winter,” the FDA said.

The FDA also announced that it “will work quickly to evaluate future data and submissions to support authorization of bivalent COVID-19 boosters for additional age groups as we receive them.”

“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,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “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.”