Watch: FDA approves updated COVID booster shots targeting Omicron

WASHINGTON (AP) — The US approved the first renewal of its COVID-19 vaccine on Wednesday. Omicron strainShots could start in the next few days.

Watch the event in the player above.

The FDA’s move tweaks recipes for shots made by Pfizer and rival Moderna that have already saved millions of lives. mod booster will help blunt yet another winter surge and curb the BA.5 omicron relatives that continue to spread widely.

“These updated boosters give us an opportunity to stay ahead of the next wave of COVID-19,” said FDA Commissioner Dr. Robert Calif.

So far, COVID-19 vaccines have targeted the original coronavirus strain, but very different variants have emerged. The new US booster is a combination, or “bivalent” shot. They contain half the original vaccine recipe and half protection against the latest Omicron versions, BA.4 and BA.5, considered the most contagious to date.

This combination is intended to enhance cross-protection against multiple variants.

Annalisa Anderson, vaccine director at Pfizer, told The Associated Press.

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The updated booster is only intended for people who have already had their primary vaccination, using the original vaccine. Whereas the dose produced by Pfizer and his partner BioNTech is aimed at people 12 and older, Moderna’s updated shot is aimed at adults. Not for first vaccination.

There is one more step before the fall booster campaign kicks off. The Centers for Disease Control and Prevention should recommend who should get additional shots. An influential CDC advisory panel will discuss evidence on Thursday, including whether those at higher risk of COVID-19 should go first.

The US has purchased over 170 million doses from two companies. Pfizer said it could ship up to 15 million doses by the end of next week. Moderna didn’t immediately say how many doses it has ready to ship, but says some will be available “in the coming days.”

The big question is whether those sick of vaccinations will roll up their sleeves again. Only one-third of those over 50 who were prompted to take a booster did so.

Immunologist E. John Werry of the University of Pennsylvania says vaccination for COVID-19 is similar to getting a flu shot in the fall or a tetanus booster after stepping on a rusty nail. It says it’s time for U.S. officials to better explain the need for regular updates. .

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Rather than a panic reaction to the new mutants, Welley said, “We need to rebrand them in ways that appear socially normal. Give them a clear and positive set of expectations.”

Here’s the problem: The original vaccine offers strong protection against severe illness and death from COVID-19 in generally healthy people, especially if they receive the all-important first booster dose. It’s not clear how much benefit the updated booster will provide beyond a temporary increase in antibodies that can fend off Omicron infection.

One reason is that the FDA approved the change prior to human studies. This is a step towards finally handling her COVID-19 vaccine renewal, like the annual change in her flu shot.

The FDA’s vaccine director, Dr. Peter Marks, emphasized that the agency is considering the “whole” of the evidence. We created updated vaccine doses to match the previous mutants, including and tested them in people. greatly enhanced antibodies. This was more than another dose of the original vaccine, but fewer recognized today’s genetically distinct BA.4 and BA.5 strains.

But instead of using these BA.1 shots, the FDA has ordered companies to brew even more modern doses that target them. Latest Omicron Mutants, causing competition to deploy them. Rather than wait a few more months for additional human studies on tweaking that very similar recipe, Marks believes the latest updates in animal testing promote “very good immune responses.” said to have shown

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“You need to refresh your immune system with something that’s actually circulating,” Marks said. .

The hope, Marks said, is that a vaccine adapted to the currently circulating subspecies might, at least for some time, do a better job of fighting not just serious illnesses, but infectious diseases.

what’s next? Moderna and Pfizer are conducting human studies to assess its value, including how it will hold up if new variants emerge.

And for children, Pfizer plans to ask the FDA to allow its newest booster for ages 5 to 11 in early October.

This is the first update in the United States to the COVID-19 vaccine recipe and is an important but expected next step, just as flu vaccines are updated annually.

And it’s not just the United States. The UK recently decided to offer adults over 50 a different booster option than Moderna. This is the first combo shot targeting his BA.1 Omicron strain. European regulators are considering whether to approve one or both of the updated formulas.

AP Health Writer Matthew Perrone contributed to this report.