US approves Pfizer, Moderna updated COVID-19 boosters targeting Omicron
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E-mail Xinhua, September 1, 2022
The U.S. Food and Drug Administration (FDA) on Wednesday authorized updated COVID-19 vaccine booster shots from Moderna and Pfizer-BioNTech that target Omicron subvariants.
The 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, according to the FDA.
The BA.4 and BA.5 Omicron subvariants are currently causing most cases of COVID-19 in the United States, and are predicted to circulate this fall and winter, according to the U.S. Centers for Disease Control and Prevention (CDC).
The Moderna updated booster is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech booster is authorized for use as a single booster dose in individuals 12 years of age and older, according to the FDA.
"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," said FDA Commissioner Robert Califf in a statement.
"We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
"The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations," Marks said.
It is the first time the FDA has authorized an updated vaccine formula since the original COVID-19 shots rolled out in the country in December 2020.
In the future, health experts expect the vaccines could be updated periodically to match current strains.
Before the shots are available to the public, an independent CDC advisors panel will meet on Thursday to review the data on the updated booster shots.
If the panel votes in favor of recommending the shots, CDC Director Rochelle Walensky would give the final sign-off and then shots could be ready for the public to administer within a few days.
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