WASHINGTON — The United States authorized its first COVID-19 vaccine updates on Wednesday, booster doses that target the most common omicron strain to date. The shooting could start in a few days.
The Food and Drug Administration’s decision changes the recipe for injections made by Pfizer and rival Moderna that have already saved millions of lives. The hope is that the modified boosters will mitigate another winter surge – and help mitigate the BA.5 omicron parent that continues to spread widely.
“These updated boosters provide us with an opportunity to get ahead of” the next wave of COVID-19, FDA Commissioner Dr. Robert Califf said.
Until now, COVID-19 vaccines have targeted the original coronavirus strain, although wildly different mutants have emerged. The new American boosters are combined or “bivalent” shots. They contain half of the original vaccine recipe and half of the protection against the latest versions of omicron, BA.4 and BA.5, which are considered the most contagious to date.
The combination aims to increase cross-protection against multiple variants.
“It really offers the broadest opportunity for protection,” Annaliesa Anderson, head of vaccines at Pfizer, told The Associated Press.
The updated reminders are only for people who have already received their primary vaccinations, using the original vaccines. The doses made by Pfizer and its partner BioNTech are for anyone 12 and older, while Moderna’s updated vaccines are for adults — if it’s been at least two months since their last primo- vaccination or their last booster. They should not be used for the first vaccinations.
One step remains before a fall booster campaign begins: The Centers for Disease Control and Prevention must recommend who should receive the additional vaccine. An influential CDC advisory panel will debate the evidence on Thursday — including whether people at high risk for COVID-19 should come first.
The United States has purchased more than 170 million doses from the two companies. Pfizer said it could ship up to 15 million of these 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 tired of vaccinations will roll up their sleeves again. Only half of vaccinated Americans received the recommended first booster dose, and only one-third of people 50 and older who were asked for a second booster did so.
It’s time for US authorities to better explain that the public should expect a COVID-19 vaccination update from time to time, just like getting a flu shot in the fall or a booster. against tetanus after stepping on a rusty fingernail, said University of Pennsylvania immunologist E. John Wherry. .
“We need to rebrand it in a socially normal way,” rather than a panicked response to New Mutants, Wherry said. “Give a clear and forward-looking set of expectations.”
Here’s the catch: The original vaccines still offer strong protection against serious illness and death from COVID-19 for generally healthy people, especially if they’ve received that first important booster dose. It’s unclear how much more benefit an updated booster will bring — beyond a temporary jump in antibodies capable of fending off an omicron infection.
One reason: The FDA cleared the changes before the human studies, a step toward eventually managing COVID-19 vaccine updates more like annual flu shot changes.
The FDA’s vaccine chief, Dr. Peter Marks, stressed that the agency considers “the totality” of the evidence. Pfizer and Moderna have already prepared updated vaccine doses to match earlier mutants — including the omicron strain named BA.1 that hit last winter — and tested them in humans. These earlier recipe changes were safe and the BA.1 version significantly increased anti-virus antibodies – more than another dose of the original vaccine – although less than those that recognized the genetically distinct BA.4 and BA.5 strains of today.
But instead of using these BA.1 injections, the FDA has ordered companies to prepare even more up-to-date doses that target these new omicron mutants, sparking a race to roll them out. Rather than wait a few more months for additional human studies of this very similar recipe modification, Marks said animal testing has shown the latest update stimulates “a very good immune response.”
“You have to refresh the immune system with what’s actually going around,” Marks said. This is why the FDA no longer allows boosters made with the original recipe for ages 12 and older.
The hope, Marks said, is that a vaccine tailored to the variants now spreading can better fight infection, not just serious illnesses, at least for a while.
And after? Even as modified plans unfold, Moderna and Pfizer are conducting human studies to help gauge their worth, including their resilience if a new mutant arises.
And for kids, Pfizer plans to ask the FDA to clear the updated boosters for ages 5 to 11 in early October.
This is the first U.S. COVID-19 vaccine recipe update, an important but long-awaited next step — like how flu shots are updated every year.
And the United States is not alone. Britain recently decided to offer adults over 50 a different booster option from Moderna, a combo shot targeting that initial BA.1 omicron strain. European regulators are considering whether to allow one or both updated formulas.
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AP Health Writer Matthew Perrone contributed to this report.
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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.
