1 of 4| This photo provided by Pfizer in September 2023 shows single-dose vials of the company’s updated COVID vaccine for adults. U.S. regulators have approved updated COVID-19 vaccines from Pfizer and Moderna, shots aimed at revving up protection this fall and winter. The Food and Drug Administration’s decision Monday, Sept. 11, 2023 is part of a shift to treat fall COVID-19 vaccine updates much like getting a yearly flu shot. (Pfizer via AP)
2 of 4| This photo provided by Pfizer in September 2023 shows a single-dose vial of the company’s updated COVID vaccine for adults. U.S. regulators have approved updated COVID-19 vaccines from Pfizer and Moderna, shots aimed at revving up protection this fall and winter. The Food and Drug Administration’s decision Monday, Sept. 11, 2023 is part of a shift to treat fall COVID-19 vaccine updates much like getting a yearly flu shot. (Pfizer via AP)
3 of 4| This photo provided by Pfizer in September 2023 shows a multi-dose vial of the company’s updated COVID vaccine for children under 5. The U.S. approved updated COVID-19 vaccines Monday, Sept. 11, 2023 hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter. (Pfizer via AP)
4 of 4| This photo provided by Pfizer in September 2023 shows a single-dose vial of the company’s updated COVID vaccine for ages 5 to 11. The U.S. approved updated COVID-19 vaccines Monday, Sept. 11, 2023 hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter. (Pfizer via AP)
US approves updated COVID vaccines to rev up protection this fall
1 of 4| This photo provided by Pfizer in September 2023 shows single-dose vials of the company’s updated COVID vaccine for adults. U.S. regulators have approved updated COVID-19 vaccines from Pfizer and Moderna, shots aimed at revving up protection this fall and winter. The Food and Drug Administration’s decision Monday, Sept. 11, 2023 is part of a shift to treat fall COVID-19 vaccine updates much like getting a yearly flu shot. (Pfizer via AP)
1 of 4
This photo provided by Pfizer in September 2023 shows single-dose vials of the company’s updated COVID vaccine for adults. U.S. regulators have approved updated COVID-19 vaccines from Pfizer and Moderna, shots aimed at revving up protection this fall and winter. The Food and Drug Administration’s decision Monday, Sept. 11, 2023 is part of a shift to treat fall COVID-19 vaccine updates much like getting a yearly flu shot. (Pfizer via AP)
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2 of 4| This photo provided by Pfizer in September 2023 shows a single-dose vial of the company’s updated COVID vaccine for adults. U.S. regulators have approved updated COVID-19 vaccines from Pfizer and Moderna, shots aimed at revving up protection this fall and winter. The Food and Drug Administration’s decision Monday, Sept. 11, 2023 is part of a shift to treat fall COVID-19 vaccine updates much like getting a yearly flu shot. (Pfizer via AP)
2 of 4
This photo provided by Pfizer in September 2023 shows a single-dose vial of the company’s updated COVID vaccine for adults. U.S. regulators have approved updated COVID-19 vaccines from Pfizer and Moderna, shots aimed at revving up protection this fall and winter. The Food and Drug Administration’s decision Monday, Sept. 11, 2023 is part of a shift to treat fall COVID-19 vaccine updates much like getting a yearly flu shot. (Pfizer via AP)
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3 of 4| This photo provided by Pfizer in September 2023 shows a multi-dose vial of the company’s updated COVID vaccine for children under 5. The U.S. approved updated COVID-19 vaccines Monday, Sept. 11, 2023 hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter. (Pfizer via AP)
3 of 4
This photo provided by Pfizer in September 2023 shows a multi-dose vial of the company’s updated COVID vaccine for children under 5. The U.S. approved updated COVID-19 vaccines Monday, Sept. 11, 2023 hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter. (Pfizer via AP)
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4 of 4| This photo provided by Pfizer in September 2023 shows a single-dose vial of the company’s updated COVID vaccine for ages 5 to 11. The U.S. approved updated COVID-19 vaccines Monday, Sept. 11, 2023 hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter. (Pfizer via AP)
4 of 4
This photo provided by Pfizer in September 2023 shows a single-dose vial of the company’s updated COVID vaccine for ages 5 to 11. The U.S. approved updated COVID-19 vaccines Monday, Sept. 11, 2023 hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter. (Pfizer via AP)
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ByLAURAN NEERGAARD
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WASHINGTON (AP) — The U.S. approved updated COVID-19 vaccines Monday, hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter.
The Food and Drug Administration decision opens the newest shots from Moderna and Pfizer and its partner BioNTech to most Americans even if they’ve never had a coronavirus vaccination. It’s part of a shift to treat fall updates of the COVID-19 vaccine much like getting a yearly flu shot.
There’s still another step: The Centers for Disease Control and Prevention must sign off. A CDC advisory panel is set to issue recommendations Tuesday on who most needs the updated shots. Vaccinations could begin later this week, and both the COVID-19 and flu shot can be given at the same visit.
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A third vaccine maker, Novavax, said its updated shot is still being reviewed by the FDA.
COVID-19 hospitalizations have been rising since late summer although –- thanks to lasting immunity from prior vaccinations and infections –- not nearly as much as this time last year.
But protection wanes over time and the coronavirus continually churns out new variants that can dodge prior immunity. It’s been a year since the last time the vaccines were tweaked, and only about 20% of adults ever received that earlier update.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” FDA vaccine chief Dr. Peter Marks said in a statement. “We very much encourage those who are eligible to consider getting vaccinated.”
Just like earlier vaccinations, the fall round is cleared for adults and children as young as age 6 months. FDA said starting at age 5, most people can get a single dose even if they’ve never had a prior COVID-19 shot. Younger children might need additional doses depending on their history of COVID-19 infections and vaccinations.
The FDA pointedly isn’t calling this latest round a “booster” but instead a vaccine updated to better match the currently circulating virus. The new recipe targets an omicron variant named XBB.1.5 — replacing outdated combination vaccines that mixed protection against the original coronavirus strain and an older version of omicron.
And while even the XBB.1.5 variant is no longer dominant, FDA determined that it’s close enough to coronavirus strains causing most COVID-19 illnesses today to offer good cross-protection. Like earlier versions, they’re expected to be most protective against COVID-19’s worst consequences rather than mild infection.
But while the FDA’s decision allows for wide use of the updated shots, the CDC will decide how strongly different groups are urged to get them.
Federal officials have said the shots still will be free to most Americans through private insurance or Medicare. But for the uninsured or underinsured, the CDC is working with health departments, clinics and certain pharmacies to temporarily provide free shots.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
FAQs
US approves updated COVID vaccines to rev up protection this fall? ›
The Food and Drug Administration decision opens the newest shots from Moderna and Pfizer and its partner BioNTech to most Americans even if they've never had a coronavirus vaccination. It's part of a shift to treat fall updates of the COVID-19 vaccine much like getting a yearly flu shot.
What does the new vaccine protect against? ›The new vaccines are designed specifically to protect against one of the newer strains of the virus: the XBB.1.5 version of Omicron, which was the dominant subvariant in June, when the FDA selected a strain to target this fall.
Will the COVID vaccine update cause herd immunity? ›While there are now vaccines to protect against COVID-19, It may be months before enough people can receive them. It is hoped, that the vaccines will eventually help bring the spread under control. Researchers estimate that 75-80% of the population would need to be vaccinated before we can have herd immunity.
What is the waning effectiveness of COVID vaccine booster? ›Nonetheless, pooled estimates show that the VE against symptomatic disease wanes at a rate comparable to that of the primary cycle, with VE decreasing from 60.4% (95% CI, 55.5%-65.4%) at 1 month after the administration of the booster dose to 13.3% (95% CI, 7.2%-19.4%) at 9 months.
What is the newest COVID booster? ›The new boosters are a much closer match to currently circulating variants than prior vaccines, say federal health officials. They're updated versions of the existing Moderna and Pfizer-BioNTech vaccines and have been formulated to target a relatively recent omicron subvariant called XBB. 1.5.
What are the disadvantages of the vaccine? ›Vaccines do have some risk for adverse reaction, the most common being redness and soreness at the injection site or fever and allergic reactions.
How long does natural immunity to COVID last? ›Other studies, including a meta-analysis of the effectiveness of COVID-19 vaccines and natural immunity, showed similar results to the PiratePACT study, with natural immunity waning after about 140 days in that cluster of studies.
Can you achieve herd immunity without a vaccine? ›To safely achieve herd immunity against COVID-19, a substantial proportion of a population would need to be vaccinated, lowering the overall amount of virus able to spread in the whole population.
What percentage of people have not had COVID? ›Nearly 1 in 4 U.S. adults and older teens had still not caught COVID-19 by the end of last year, according to new estimates from the Centers for Disease Control and Prevention, while 77.5% had antibodies from at least one prior infection.
Is the booster different than the second shot? ›An additional dose is different from a booster dose. Some people, those who are immunocompromised, may not develop the same immune response level after vaccination as others, so they made need an additional dose before their booster. A booster dose is recommended as protection from the vaccine may wane over time.
What is the difference between COVID booster and regular shot? ›
A COVID booster shot is an additional dose or doses of a vaccine given after the protection provided by the original shot(s) has begun to decrease over time.
How long between booster vaccines is effective? ›The systematic review, published in The Lancet Respiratory Medicine, analyzed 68 studies that reported vaccine effectiveness immediately and at least 112 days after a primary vaccine series and at least 84 days after a booster dose.