Tuesday, November 29, 2022

FDA authorizes updated COVID-19 boosters for children as young as 5

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The US on Wednesday approved updated COVID-19 boosters for children ages 5 and older to expand protection against an expected winter wave.

Optimized boosters were introduced last month for Americans 12 and older, with doses altered to target today’s most common and contagious omicron relative. Though there wasn’t a major rush, federal health officials are urging people to seek the extra protection ahead of holiday gatherings.

Now the Food and Drug Administration has given the green light for elementary school-age kids to also get the updated booster doses — one from Pfizer for 5- to 11-year-olds and a version of rival Moderna for those young as 6.

There is one more step before parents can bring their children for the new vaccination: the Centers for Disease Control and Prevention, which recommend vaccine use, must opt ​​out.

Americans may be tired of repeated calls to get fortified against COVID-19, but experts say the updated shots have an advantage: they contain half the prescription that targeted the original coronavirus strain and half Protection against the dominant BA.4 and BA.5 Omicron versions.

These combination or “bivalent” boosters are designed to augment immune defenses so people are better protected against serious illnesses, regardless of whether they encounter an Omicron relative — or another mutant more closely resembling the original virus — in the coming months .

“We want to have the best of both worlds,” said Dr. Bill Gruber, a Pfizer pediatrician, told The Associated Press. He hopes the updated footage will “rekindle interest in protecting children for the winter.”

The updated boosters are “extremely important” for keeping children healthy and in school, said Dr. Jason Newland, a pediatric infectious disease specialist at Washington University in St. Louis.

Parents should know that “there are no safety concerns about the bivalent vaccines, whether Moderna or Pfizer,” Newland added.

Only people who received their first vaccinations – with one of the original formula versions – qualify for an updated booster. That means about three-quarters of Americans ages 12 and older are eligible. As of this past weekend, only at least 13 million had received an updated refresher, estimated White House COVID-19 coordinator Dr. Ashish Jha, on Tuesday.

Unfortunately for paediatricians, it was more difficult to give children their first vaccinations. Less than a third of 5- to 11-year-olds have received their two primary series of vaccinations and would therefore qualify for the new booster.

That age group gets child-sized doses of the updated booster — and they can get it at least two months after their last dose, whether it was a primary immunization or a previous booster, the FDA said.

Pfizer said it could ship up to 6 million child-size doses within a week of approval, in addition to ongoing shipments of adult doses.

Previously, Moderna’s updated booster was only released for adults. Wednesday’s FDA action approved the booster shot for teens and children as young as 6 years old.

For even younger toddlers, the first shots for the under-5 age group didn’t open up until mid-June – and it will be a few months before regulators decide if they also need a booster with the updated prescription.

Exactly how much protection does an updated COVID-19 booster shot offer? That’s hard to know. Pfizer and Moderna begin trials in young children.

But the FDA has approved the COVID-19 booster shot adjustments without requiring human test results — just like it approves annual changes to flu vaccines. That’s partly because both companies had already examined experimental recordings optimized for previous COVID-19 variants, including an earlier Omicron version, and found that they safely revved virus-fighting antibodies.

“It’s clearly a better vaccine, a major upgrade over what we had before,” Jha said earlier this week.

Jha urged adults to get their updated vaccination in October – like they get flu shots – or at least well before holiday gatherings with high-risk family and friends. People who recently had COVID-19 still need the booster but can wait about three months, he added.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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