FDA clears updated COVID booster vaccines targeting newest omicron variant strain; shots could begin within days

The US on Wednesday approved its first update to COVID-19 vaccines, booster doses targeting today’s most common Omicron strain. Gunshots could begin within days.

The Food and Drug Administration’s move streamlines the recipe of shots from Pfizer and rival Moderna, which have already saved millions of lives. The hope is that the modified boosters will dampen another winter surge.

“These vaccine formulations will contain against the original strain of the virus as well as the latest Omicron strains,” said Dr. Benjamin Singer of Northwestern Medicine.

“You’ll see me at the head of the line,” said Dr. FDA vaccine chief Peter Marks told The Associated Press just before his agency approved the new doses.

Until now, COVID-19 vaccines have targeted the original strain of coronavirus, even as entirely different mutants have emerged. The new US boosters are combination or “bivalent” shots. They contain half the original vaccine recipe and half protection against the latest Omicron versions called BA.4 and BA.5, believed to be the most contagious yet.

The combo aims to increase cross protection against multiple variants.

“It really offers the broadest opportunity for protection,” Pfizer vaccine chief Annaliesa Anderson told the AP.

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The updated booster shot replaces the current booster shot and is only for people who have already taken their primary dose. The federal agency said the modified vaccine should be taken two months after your last vaccination. However, the FDA hasn’t made a recommendation on a time frame if you’ve recently had COVID, although doctors are predicting it could be similar.

Manufactured by Pfizer and its partner BioNTech, the doses are intended for anyone aged 12 and over who needs a booster shot, while Moderna’s updated shots are intended for adults. They must not be used for primary vaccinations.

“I suppose if you’ve recently had COVID infection, you should get the flare-up as long as it’s more than two months after infection,” said Dr. Max Brito, a UIC infectious disease specialist.

The FDA has high hopes that the new booster shot will be better at preventing infections and lasting longer.

Similar to the flu, the aim is to switch to an annually adjusted vaccination.

“MRNA technology is very versatile, so you can tweak some things with the vaccine to make it effective against a new strain,” Brito said.

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

The US has bought more than 170 million cans from the two companies. Pfizer said it could ship up to 15 million of those doses by the end of next week.

The big question is whether vaccine-weary people will roll up their sleeves again. Only half of vaccinated Americans received the first recommended booster dose, and only a third of those over the age of 50 who were recommended a second booster dose did.

It’s time US authorities better explained that the public should expect an updated COVID-19 shot from time to time, just like a fall flu shot or a tetanus booster shot after stepping on a rusty nail is, said immunologist E. John Wherry of the University of Pennsylvania.

“We need to rebrand it in a socially normal-looking way,” rather than a panicked response to new mutants, Wherry said. “Give clear, forward-looking expectations.”

“In my opinion, a full vaccination includes a booster shot,” said Dr. Singer. “You really need the refresher to have the best possible protection against Omicron.”

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Here’s the rub: The original vaccines still offer strong protection against serious illness and death from COVID-19 for most generally healthy people, especially if they’ve had that important first booster shot. It’s not clear how much more benefit an updated booster shot will bring—aside from a temporary surge in antibodies that can fight off Omicron infection.

One reason: The FDA approved the changes ahead of human trials, a move to eventually treat COVID-19 vaccine updates more like annual flu shots.

First, the FDA reviewed human studies of previous Pfizer and Moderna attempts to update their vaccines — shots consistent with the Omicron strain that struck last winter. This recipe change was safe and significantly boosted the antibodies targeting the earlier variant – better than another dose of the original vaccine – while adding a little protection against today’s genetically different BA.4 and BA.5 omicron versions added.

But the FDA ordered companies to brew even more topical doses that target these latest omicron mutants instead, sparking a race to launch shots in less than three months. Rather than waiting a few more months for additional human studies on this recipe change, Marks said animal studies showed the latest update spurs “a very good immune response.”

The hope, he said, is that a vaccine matched to the variants currently in circulation could be better at fighting infections, not just serious illnesses, at least for a while.

What’s next? Even as modified shots hit the market, Moderna and Pfizer are conducting human studies to assess their worth, including how they’ll hold up if a new mutant emerges.

And for children, Pfizer plans to ask the FDA to allow updated booster shots for 5- to 11-year-olds in early October.

It’s the first U.S. update of the COVID-19 vaccine prescription, an important but expected next step — just as flu vaccines are updated every year.

And the US is not alone. The UK recently decided to offer adults over 50 a different booster option than Moderna, a combination shot targeting this original BA.1 Omicron strain. European regulators are considering approving one or both of the updated formulas.

ABC7 Chicago and Associated Press contributed to this post.

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https://6abc.com/omicron-booster-covid-vaccine-fda-us/12182998/ FDA clears updated COVID booster vaccines targeting newest omicron variant strain; shots could begin within days

Alley Einstein

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