The U.S. Food and Drug Administration authorized a pair of COVID-19 booster vaccines Wednesday that are specifically formulated to target the omicron variant of the virus and two of its most common subvariants. Rollout could be as early as Monday pending CDC clearance.
The U.S. Centers for Disease Control and Prevention is expected to give its approval of the omicron-specific boosters within the next week.
The FDA amended its emergency use authorizations for the Moderna and Pfizer vaccines to allow for the omicron-specific booster, which targets the BA.4 and BA.5 subvariants while still protecting against the original COVID virus strain as well.
The Moderna booster will be available to adults while the Pfizer booster will be available to people ages 12 and older.
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"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," FDA Commissioner Dr. Robert Califf said in a statement.
According to the FDA, the new booster vaccines will be used for all future booster vaccinations and the original mRNA vaccines will only be authorized for an initial vaccine series going forward.
People will be eligible for one dose of the omicron-specific boosters if it has been at least two months since completing their initial vaccination series.
"The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "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."
