US clears updated COVID boosters targeting newest variants

WASHINGTON — The U.S. on Wednesday licensed its first replace to COVID-19 vaccines, booster doses that concentrate on as we speak’s commonest omicron pressure. Shots might start inside days.

The transfer by the Food and Drug Administration tweaks the recipe of pictures made by Pfizer and rival Moderna that have already got saved hundreds of thousands of lives. The hope is that the modified boosters will blunt yet one more winter surge — and assist tamp down the BA.5 omicron relative that continues to unfold broadly.

“These updated boosters current us with a chance to get forward” of the next COVID-19 wave, said FDA Commissioner Dr. Robert Califf.

Until now, COVID-19 vaccines have targeted the original coronavirus strain, even as wildly different mutants emerged. The new U.S. boosters are combination, or “bivalent,” shots. They contain half that original vaccine recipe and half protection against the newest omicron versions, BA.4 and BA.5, that are considered the most contagious yet.

The combination aims to increase cross-protection against multiple variants.

“It really provides the broadest opportunity for protection,” Pfizer vaccine chief Annaliesa Anderson told The Associated Press.

The updated boosters are only for people who have already had their primary vaccinations, using the original vaccines. Doses made by Pfizer and its partner BioNTech are for anyone 12 and older while Moderna’s updated shots are for adults — if it has been at least two months since their last primary vaccination or their latest booster. They’re not to be used for initial vaccinations.

There’s one more step before a fall booster campaign begins: The Centers for Disease Control and Prevention must recommend who should get the additional shot. An influential CDC advisory panel will debate the evidence Thursday — including whether people at high risk from COVID-19 should go first.

The U.S. has purchased more than 170 million doses from the two companies. Pfizer said it could ship up to 15 million of those doses by the end of next week. Moderna didn’t immediately say how many doses are ready to ship but that some will be available “in the coming days.”

The big question is whether people weary of vaccinations will roll up their sleeves again. Just half of vaccinated Americans got the first recommended booster dose, and only a third of those 50 and older who were urged to get a second booster did so.

Here’s the rub: The original vaccines still offer strong protection against severe disease and death from COVID-19 for generally healthy people, especially if they got that important first booster dose. It’s not clear just how much more benefit an updated booster will bring — beyond a temporary jump in antibodies capable of fending off an omicron infection.

Still, “people have to realize this is a different kind of booster than was previously available. It will work better at protecting against omicron,” said virologist Andrew Pekosz of the Johns Hopkins Bloomberg School of Public Health.

Even individuals who had an earlier omicron model nonetheless can get reinfected so “you should definitely go for the booster even if you’ve been infected in the last year,” added Pekosz. He thinks “if we can get good buy-in to use this, we might really be able to make a dent” in COVID-19 cases.

The FDA cleared the modifications ahead of studies in people, a step toward eventually handling COVID-19 vaccine updates more like yearly changes to flu shots.

FDA vaccine chief Dr. Peter Marks stressed the agency considered “the totality” of proof. Pfizer and Moderna have beforehand brewed vaccine doses updated to match earlier mutants — together with the omicron pressure named BA.1 that struck final winter — and examined them in individuals. Those earlier recipe modifications had been secure, and the BA.1 model considerably boosted virus-fighting antibodies — greater than one other dose of the unique vaccine — though fewer that acknowledged as we speak’s genetically distinct BA.4 and BA.5 strains.

But as a substitute of utilizing these BA.1 pictures, FDA ordered the businesses to brew much more up-to-date doses that concentrate on these newest omicron mutants, sparking a race to roll them out. Rather than ready just a few extra months for extra human research of that very related recipe tweak, Marks stated animal exams confirmed the most recent replace spurs “a very good immune response.”

“One needs to refresh the immune system with what is actually circulating,” Marks stated. That’s why FDA is also not authorizing boosters made with the unique recipe for these 12 and older.

The hope, Marks stated, is {that a} vaccine matched to at present spreading variants may do a greater job preventing an infection, not simply critical sickness, not less than for some time.

What’s subsequent? Even as modified pictures roll out, Moderna and Pfizer are conducting human research to assist assess their worth, together with how they maintain up if a brand new mutant comes alongside.

And for kids, Pfizer plans to ask FDA to permit updated boosters for 5- to 11-year-olds in early October.

It’s the primary U.S. replace to the COVID-19 vaccine recipe, an essential however anticipated subsequent step — like how flu vaccines get updated each year.

And the U.S. isn’t alone. Britain not too long ago determined to supply adults over 50 a special booster possibility from Moderna, a combo shot targeting that preliminary BA.1 omicron pressure. European regulators are contemplating whether or not to authorize one or each of the updated formulation.


AP Health Writer Matthew Perrone contributed to this report.


The Associated Press Health and Science Department receives help from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely chargeable for all content material.

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