COVID vaccination reboot coming this fall to add tweaks for new omicron subvariants

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

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Lalain Reyeg administers a COVID-19 booster shot to Army veteran Gary Nasakaitis last September at the Edward Hines Jr. VA Hospital in the west suburbs.

Lalain Reyeg administers a COVID-19 booster shot to Army veteran Gary Nasakaitis last September at the Edward Hines Jr. VA Hospital in the west suburbs.

Scott Olson / Getty Images

At least some adults in the United States might be getting updated COVID-19 shots this fall after advisers to the federal Food and Drug Administration voted that it’s time to tweak booster doses to better match the most recent omicron subvariants.

They made that recommendation after wrestling over exactly how to modify doses now when there’s no way to know how the rapidly mutating virus will evolve by fall — especially given that people who get today’s recommended boosters remain strongly protected against the worst outcomes of coronavirus infections.

The FDA panel voted 19-2 that the boosters should contain some version of the super-contagious omicron variant to be ready for an anticipated fall booster campaign.

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

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

“None of us has a crystal ball” to know the next threatening variant, said FDA vaccine chief Dr. Peter Marks. “We may at least bring the immune system closer to being able to respond to what’s circulating” rather than just to older strains of the virus.

It’s not clear who would be offered a tweaked booster — they might be urged only for older adults or those at high risk from the virus.

But after the FDA decides on the recipe change, Pfizer and Moderna will have to seek authorization for the appropriately updated doses, which should give health authorities time to settle on a fall strategy regarding who should get the new booster shots.

Current COVID-19 vaccines have saved millions of lives globally. With a booster dose, those vaccines that have been distributed 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 last winter’s surge has been replaced by its genetically distinct relatives. The two newest omicron cousins, called BA.4 and BA.5, together now make up half of U.S. cases, according to the federal Centers for Disease Control and Prevention.

Pfizer and Moderna already were brewing boosters that add protection to the first omicron mutant. Their combination shots — what scientists call bivalent vaccines — substantially boosted levels of antibodies capable of fighting that variant, more so than just giving another dose of today’s vaccine. Both companies found the tweaked shots also offered some cross-protection against those worrisome BA.4 and BA.5 mutants, though not nearly as much.

Many scientists favor the combination approach because it preserves the original vaccines’ proven benefits, which include some cross-protection against mutations that have cropped up during the pandemic.

Pfizer and Moderna said they’d have plenty of omicron-targeted combo shots by October, but Moderna said switching to target omicron’s newest relatives might delay its version another month.

Complicating the decision is that only half of vaccinated Americans have received that all-important first booster. And while the CDC says protection against hospitalization has slipped some for older adults, a second booster — recommended for people 50 and older — seems to restore it, but only a quarter of those eligible for the additional booster have gotten one.

Marks said that, by tweaking the shots, “We’re hoping we can convince people to go get that booster to strengthen their immune response and help prevent another wave.”

Many Americans haven’t had their first vaccinations yet, including young children who just became eligible — and it’s not clear whether tweaked boosters eventually might lead to a change in the primary vaccine. But the FDA’s advisers said it’s important to go ahead and study updated vaccine recipes in children, too.

A third company, Novavax, is awaiting FDA authorization of a more traditional kind of COVID-19 vaccine, protein-based shots. Novavax says a booster of its regular vaccine promises a good immune response against the new omicron mutants without a recipe change.

Advisers to the World Health Organization recently said omicron-tweaked shots would be most beneficial as a booster because they should increase the breadth of people’s cross-protection against multiple variants.

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

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