On Wednesday, the United States authorized the first update of COVID-19 vaccines, booster doses targeting the most popular Omicron strain today. Shots can begin in a matter of days.
The move by the Food and Drug Administration amends the prescription for shots made by Pfizer and rival Moderna that has already saved millions of lives. The hope is that the modified boosters will ease the winter rush again.
“You’ll see me at the front of the line,” FDA Vaccines Chief Dr. Peter Marks told the Associated Press shortly before his agency cleared the new doses.
So far, COVID-19 vaccines have targeted the original strain of coronavirus, even with entirely different mutations. The new American reinforcements are combined or “bivalent” shots. Contains half the original vaccine prescription and half the protection against the newest omicron versionscalled BA.4 and BA.5, are considered the most infectious to date.
The group aims to increase cross-protection against multiple variants.
“It really does provide the broadest opportunity for protection,” Pfizer’s head of vaccines, Annalisa Anderson, told the Associated Press.
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Updated boosters are only for people who have already received their initial vaccinations, using original vaccines. doses Made by Pfizer And its partner BioNTech is for anyone 12 or older, while Moderna’s updated shots are for adults — if it’s been at least two months since their last primary vaccination or last booster dose. It should not be used for primary vaccinations.
One more step before the fall-boosting campaign begins: The Centers for Disease Control and Prevention should recommend who should get the extra shot. An influential CDC advisory panel will discuss the evidence Thursday — including whether people in High risk of COVID-19 He must go first.
“As we get closer to the fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose of the bivalent COVID-19 vaccine to better protect against currently circulating variants,” FDA Commissioner Dr. Robert Califf said. In a statement.
The United States has purchased more than 170 million doses from the two companies. Pfizer said it may ship up to 15 million of those doses by the end of next week.
The big question is whether people who are sick of vaccinations will ever roll up their sleeves again. Only half of Americans who were vaccinated got First recommended booster doseand only a third of those 50 years of age or older who were urged to get a second booster dose did so.
John Wehrey, an immunologist at the University of Pennsylvania, said it’s time for US authorities to better explain that the public should expect an updated COVID-19 vaccination now and then, just like getting a fall flu shot or a tetanus booster after they Step in a rusty nail. .
“We need to rename it in a social, natural-looking way,” Wehrey said, rather than in a panicked response to new mutations. “Give a set of clear and future expectations.”
Here’s the catch: The original vaccines still provide powerful protection against severe illness and death from COVID-19 for most generally healthy people, especially if they get that important first booster dose. It’s not clear just how much of a benefit the updated booster will bring — beyond the temporary jump in antibodies able to fend off omicron infection.
One reason: The FDA cleared the edits before the studies were done in people, a step toward eventually treating COVID-19 vaccine updates more like Annual flu vaccinations.
First, the FDA examined human studies of previous attempts by Pfizer and Moderna to update their vaccines — shots matching the omicron strain that hit last winter. The prescription change was safe, and it significantly boosted antibodies targeting the previous variant–better than another dose of the original vaccine–while adding little protection against today’s genetically distinct Omicron BA.4 and BA.5 versions.
But the FDA has ordered companies to prepare more modern doses targeting the latest omicron spikes instead, sparking a race to release the shots in less than three months. Rather than wait a few more months for additional human studies for this recipe, Marks said animal tests have shown that the latest update stimulates a “very good immune response.”
The hope, he said, is that a vaccine matching the variants currently circulating might do a better job of fighting infection, not just serious disease, at least for a while.
What’s Next? Even as the modified shots are released, Moderna and Pfizer are conducting human studies to help assess its value, including how it holds up in the event of a new mutation.
For children, Pfizer plans to ask the U.S. Food and Drug Administration to allow the use of the updated boosters for children ages 5 to 11 in early October.
It’s the first US update of the COVID-19 vaccine prescription, and it’s an important but predictable next step — like how flu vaccines are updated each year.
And the United States is not alone. Britain recently decided to offer adults over 50 years of age a different booster option than Moderna, a combination shot targeting the primary BA.1 omicron strain. European regulators are considering whether one or both of the updated versions will be authorized.
Health writer AP Matthew Peroni Contribute to this report.
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