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WASHINGTON — Another round of updated COVID-19 booster shots for older and medically vulnerable Americans was authorized Tuesday by the Food and Drug Administration.
The federal agency also announced that the updated bivalent booster shots, targeting recent versions of the omicron variant as well as the original strain of the virus, will replace all doses administered to those 6 months and older.
Now, most unvaccinated people can get a single shot of the bivalent vaccine, rather than multiple doses of the original shots, the FDA said in a news release, noting the original Pfizer and Moderna vaccines are no longer authorized for use in the United States.
The decision is part of the federal government's effort to simplify COVID-19 vaccinations.
The FDA "believes that this approach will help encourage future vaccination," Dr. Peter Marks, director of the agency's Center for Biologics Evaluation and Research, said in a statement.
"At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines," Marks said. The FDA said there's evidence that "almost all" of the U.S. population 5 and older now have antibodies, either from vaccination or infection.
Those antibodies "can serve as a foundation for the protection provided by the bivalent vaccines. COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination," he said.
"The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death," the FDA official said.
The additional updated COVID-19 booster shot is available to those 65 and older at least four months after receiving the first updated booster dose. Those with immune deficiencies can get another shot two months after an updated booster dose.
The FDA is also giving health care providers the discretion to administer additional doses to immunocompromised individuals, although for children 6 months to 4 years old, eligibility for more shots will depend on what vaccine they previously received.
More detailed recommendations for additional booster doses for immunocompromised individuals is expected to be discussed at a Centers for Disease Control and Prevention advisory committee meeting Wednesday, Medpage Today reported.
The updated vaccine has been offered since last fall, but fewer than 17% of Americans — and just over 15% of Utahns — have gotten the shot. Most are not currently eligible for another dose, the FDA said.
The shots will come from the Biden administration's "substantial stockpile" and are anticipated to be free of charge, even as the U.S. is ending the national emergency associated with the COVID-19 pandemic, according to the New York Times.
A new bivalent booster dose is set to be developed later this year to go after more current versions of the coronavirus. The intent is to make the newest COVID-19 booster update available to everyone in late summer or early fall annually, just like a flu shot.
The FDA said in its news release that it "intends to make decisions about future vaccination after receiving recommendations on the fall strain composition at an FDA advisory committee in June."
Offering an extra dose of the current bivalent vaccine sooner for those who are older and immunocompromised has been discussed for some time, and has already been recommended in the United Kingdom and Canada.
But Dr. Leisha Nolen, state epidemiologist with the Utah Department of Health and Human Services, questioned the benefit of offering an additional shot before the fall. That's the reason the FDA is taking so long to decide, she said before the agency released its announcement.
"People do have waning immunity. There's no question older people wane faster," Nolen said. "But the data really isn't showing strong evidence that it's going to have a huge impact right now."
More shots could also lead to more confusion among the public, the epidemiologist said.
"I think we are also trying to balance that fine line of telling people to go get vaccine and getting them to listen to us now and making sure they listen again to us in the fall," Nolen said, when the newer updated booster doses are anticipated.
"I think everybody expects this infection to become more of a seasonal infection, where we get waves during the wintertime," she said. "So getting people that fall booster I think is going to be our big push."
