FDA advisers recommend updating COVID booster shots for fall

At least some U.S. adults could receive updated COVID-19 vaccines this fall, as government advisers voted on Tuesday that it was time to adjust booster doses to better match the newer virus variants.

Food and Drug Administration advisers have wondered how to change doses now when there’s no way to know how the rapidly mutating virus will evolve in the fall – especially since people who get the Today’s recommended boosters remain strongly protected against the worst outcomes of COVID-19.

In the end, the FDA panel voted 19 to 2 for the COVID-19 boosters to contain a version of the super contagious omicron variant, to be ready for a recall campaign expected in the fall.

“We’re going to be behind the eight ball if we wait any longer,” said adviser Dr. Mark Sawyer of the University of California, San Diego.

The FDA will have to decide on the exact recipe, but expect a combination shot that adds protection against omicron or some of its new relatives to the original vaccine.

“None of us have a crystal ball” to know the next threatening variant, said FDA vaccine chief Dr. Peter Marks. But “we can at least bring the immune system closer to its ability to respond to what’s circulating” now rather than much older virus strains.

It’s unclear who would be offered a modified booster – they might only be recommended for the elderly or those at high risk of contracting the virus. But the FDA should decide on the recipe change in a few days, and then Pfizer and Moderna will have to seek authorization for the properly updated doses, while health authorities agree on a fall strategy.

Current COVID-19 vaccines have saved millions of lives globally. With a booster dose, those used in the United States retain strong protection against hospitalization and death, but their ability to block infection dropped markedly when omicron appeared. And the omicron mutant that caused the Winter Wave has been replaced by its genetically distinct relatives.. The two new omicron cousins, called BA.4 and BA.5, together now account for half of the cases in the United States, according to the Centers for Disease Control and Prevention.

Pfizer and Moderna were already preparing boosters that add protection to the first omicron mutant. Their combined injections, what scientists call “bivalent” vaccines, dramatically increased the levels of antibodies capable of fighting this variant, more than just giving another dose of the current vaccine.

The two companies found that the modified blueprints also offered cross-protection against these disturbing BA.4 and BA.5 mutants, but not as much.

Many scientists favor the combination approach because it preserves the proven benefits of the original vaccines, which include some cross-protection against other mutants that emerged during the pandemic.

The question facing the FDA is the correct recipe change. The two companies said they would have plenty of combined hits targeted at omicron by October, but Moderna said targeting new omicron parents could delay its release by a month.

To further complicate the decision, only half of vaccinated Americans received that all-important first booster. And while the CDC says protection from hospitalization has diminished somewhat for older adults, a second booster recommended for people age 50 and older appears to restore it. But only a quarter of those eligible for the extra booster got one.

Marks said that by adjusting the injections, “we hope we can convince people to go for this booster to boost their immune response and help prevent another wave.”

The logistics will be difficult. Many Americans have not yet received their first vaccines, including young children who have just become eligible – and it is unclear whether modified reminders could eventually lead to a change in the primary vaccine. But FDA advisers said it was important to move forward and also study updated vaccine recipes in children.

And another complexity: A third company, Novavax, is awaiting FDA clearance for a more traditional type of COVID-19 vaccine, protein-based vaccines. Novavax argued on Tuesday that a booster of its regular vaccine promises a good immune response against new omicron mutants with no change in recipe.

World Health Organization advisers recently said that modified omicron injections would be most beneficial as a booster only, as they are expected to increase the extent of people’s cross-protection against multiple variants.

“We don’t want the world to lose faith in the vaccines currently available,” said Dr Kanta Subbarao, a virologist who chairs this WHO committee.

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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.

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