FDA Clears Updated Covid Boosters Targeting Newest Variants

WASHINGTON — The U.S. on Wednesday authorized its first update to COVID-19 vaccines, booster doses that target today’s most common omicron strain. In a matter of days, shots may begin.

Food and Drug Administration changes the formulation of Pfizer and Moderna’s shots, which have helped save millions of people. It is hoped that modified boosters will stop another winter surge.

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

COVID-19 has been targeting the coronavirus original strain until now. However, there have also been many new mutants. The new U.S. boosters are combination, or “bivalent,” shots. These boosters contain 50% of the original vaccine and provide protection against new omicron varieties, known as BA.4 or BA.5, which are the most contagious.

Combining the two will increase cross protection against different variants.

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

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Only people with the updated boosters can use them if they have had their original primary 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.

“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants,” FDA Commissioner Dr. Robert Califf said in a statement.

Over 170 million doses of the drug have been bought by the U.S. Pfizer stated that it may ship as many as 15 million doses of these drugs by next week.

It is not clear whether those who are tired of getting vaccinated will get up and go again. Half of Americans who had been vaccinated received the second recommended booster dose. Only a third, or one in three of Americans over 50 were encouraged to obtain a second booster.

It’s time for U.S. authorities to better explain that the public should expect an updated COVID-19 vaccination every so often, just like getting a fall flu shot or a tetanus booster after stepping on a rusty nail, said University of Pennsylvania immunologist E. John Wherry.

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

Here’s the rub: The original vaccines still offer strong protection against severe disease and death from COVID-19 for most 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.

One reason was that FDA had approved the modification before any studies were conducted in human subjects. This is a significant step towards eventually managing COVID-19 vaccination updates like annual flu shots.

First, FDA checked human studies of earlier Pfizer and Moderna attempts to update their vaccines — shots matching the omicron strain that struck last winter. That recipe change was safe, and substantially boosted antibodies targeting the earlier variant — better than another dose of the original vaccine — while adding a little protection against today’s genetically distinct BA.4 and BA.5 omicron versions.

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FDA directed the FDA to order companies to make more current doses to target these newest mutants. This sparked a rush to produce shots within three months. Rather than waiting a few more months for additional human studies of that recipe tweak, Marks said animal tests showed the latest update spurs “a very good immune response.”

His hope was that vaccines that are more closely matched with the currently spread variants would do a better job of fighting infection.

What’s next? Moderna and Pfizer continue to conduct human studies in order to assess the value of modified shots, as well as how they would hold up to a new mutation.

Pfizer will ask FDA in October to approve boosters that are updated for children aged 5-11 years old.

It’s the first U.S. update to the COVID-19 vaccine recipe, an important but expected next step — like how flu vaccines get updated every year.

And the U.S. isn’t alone. Britain has recently offered adults over 50 an alternative booster to Moderna. This combo shot targets the initial BA.1 micron strain. European regulators will decide whether or not to approve one of these updated formulas.

AP Health Writer Matthew PerroneContributed to the report.

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