People 65 and older and those who are immunocompromised are now eligible for another COVID-19 booster shot.
In an amendment issued Tuesday, the Food and Drug Administration changed the authorization for boosters from Moderna and Pfizer/BioNTech to allow them to be given a second time to people whose protection against COVID-19 likely fades quickly.
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For healthy, younger people, new boosters are not yet needed, the agency said, promising to make a recommendation for them early this summer.
The new ruling allows:
- People over 65 to get another booster at least four months after their previous one.
- People with some immunocompromising conditions to get boosters as often as every two months, at their doctor’s recommendation.
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COVID-19 vaccines have been very effective at preventing severe disease and death, but protection against mild disease fades after a few months, studies show.
For healthy, younger people, an infection is not likely to be serious. But for people whose protection is already limited by age or immune status, every infection could be dangerous, which is why the FDA wants them to have access to more frequent shots.
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FDA to decide which variants the fall COVID vaccines should address
All Moderna and Pfizer-BioNTech shots are now considered “bivalent” because they take aim at both the original virus and the BA.4/BA.5 variants. None of those remains in the U.S., according to the Centers for Disease Control and Prevention, but protection against them seems to cover the known variants.
XBB.1.5 remains the dominant variant in the U.S., as it has been since January, though it’s prevalence is beginning to slip slightly, replaced by other XBB variants. The XBB variants are descendants of the original omicron variant, which swept across the world in late 2021 and early 2022.
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In June, an FDA advisory committee will meet to discuss which variants COVID vaccines should address this fall, an approach typically used for flu vaccines.
Novavax prepping COVID booster for this fall
Novavax, which uses a traditional protein-based technology for its COVID vaccine, also plans to have its shots available for the fall, though it takes longer to manufacture than the two mRNA vaccines.
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Silvia Taylor, the company’s chief corporate affairs and advocacy officer, said Novavax is working closely with the FDA and is currently manufacturing several options “at risk,” only making available whichever one the FDA chooses to pursue.
What is now considered fully vaccinated?
The FDA’s moves also aim to simplify the vaccine regimen, now that the vast majority of Americans have had at least one shot or infection, or likely both.
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Because they have likely been infected already, anyone who has not yet been vaccinated can now get one shot, rather than three, to be considered protected, the FDA said.
Here’s how it breaks down for young children:
•Unvaccinated children ages 6 months through 5 years of age may receive a two-dose series of the Moderna vaccine or a three-dose series of the Pfizer-BioNTech bivalent vaccine (although that one is aimed at children 6 months to age 4).
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•Unvaccinated children who are 5 may receive two doses of the Moderna vaccine or a single dose of the Pfizer-BioNTech vaccine.
•Vaccinated children 6 months through 5 years – who have already received one, two or three vaccine doses – may get a booster, but the number of doses they receive will depend on the vaccine and their vaccination history, the FDA said.
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‘Vaccines prevent the most serious outcomes’
In a statement Tuesday, Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, explained the move:
“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination.
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“COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”
