FDA clears updated COVID boosters for kids as young as 5
By LAURAN NEERGAARD, AP Medical Writer
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The U.S. on Wednesday authorized updated COVID-19 boosters for children as young as 5, seeking to expand protection ahead of an expected winter wave.
Tweaked boosters rolled out for Americans 12 and older last month, doses modified to target today’s most common and contagious omicron relative. While there wasn’t a big rush, federal health officials are urging that people seek the extra protection ahead of holiday gatherings.
Now the Food and Drug Administration has given a green light for elementary school-age kids to get the updated booster doses, too — one made by Pfizer for 5- to 11-year-olds, and a version from rival Moderna for those as young as 6.
There’s one more step before parents can bring their kids in for the new shot: The Centers for Disease Control and Prevention, which recommends how vaccines are used, must sign off.
Americans may be tired of repeated calls to get boosted against COVID-19 but experts say the updated shots have an advantage: They contain half the recipe 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 broaden immune defenses so that people are better protected against serious illness whether they encounter an omicron relative in the coming months — or a different mutant that’s more like the original virus.
“We want to have the best of both worlds,” Pfizer’s Dr. Bill Gruber, a pediatrician, told The Associated Press. He hopes the updated shots will “re-energize interest in protecting children for the winter.”
The updated boosters are “extremely important” for keeping kids healthy and in school, said Dr. Jason Newland, a pediatric infectious disease specialist at Washington University in St. Louis.
Parents should know “there is no concern from the safety perspective with the bivalent vaccines, whether Moderna or Pfizer,” Newland added.
Only people who’ve gotten their initial vaccinations — with any of the original-formula versions — qualify for an updated booster. That means about three-fourths of Americans 12 and older are eligible. As of last weekend, only at least 13 million had gotten an updated booster, White House COVID-19 coordinator Dr. Ashish Jha estimated Tuesday.
To pediatricians’ chagrin, getting children their first vaccinations has been tougher. Less than a third of 5- to 11-year-olds have had their two primary doses and thus would qualify for the new booster.
This age group will get kid-size doses of the updated booster — and they can receive it at least two months after their last dose, whether that was a primary vaccination or an earlier booster, the FDA said.
Pfizer said it could ship up to 6 million kid-sized doses within a week of authorization, in addition to ongoing adult-dose shipments.
Until now, Moderna’s updated booster was cleared only for adults. Wednesday’s FDA action authorized the booster for teens as well as children as young as age 6.
As for even younger tots, first vaccinations didn’t open for the under-5 age group until mid-June — and it will be several more months before regulators decide if they’ll also need a booster using the updated recipe.
Exactly how much protection does an updated COVID-19 booster shot offer? That’s hard to know. Pfizer and Moderna are starting studies in young children.
But the FDA cleared the COVID-19 booster tweaks without requiring human test results — just like it approves yearly changes to flu vaccines. That’s partly because both companies already had studied experimental shots tweaked to target prior COVID-19 variants, including an earlier omicron version, and found they safely revved up virus-fighting antibodies.
“It’s clearly a better vaccine, an important upgrade from what we had before,” Jha said earlier this week.
Jha urged adults to get their updated shot in October — like they get flu vaccinations — or at least well before holiday gatherings with high-risk family and friends. People who’ve recently had COVID-19 still need the booster but can wait about three months, he added.
Pfizer via AP
Answer: They're combination or "bivalent" shots that contain half the original vaccine that's been used since December 2020 and half protection against today's dominant omicron versions, BA.4 and BA.5. It's the first update to COVID-19 vaccines ever cleared by the Food and Drug Administration.
AP file
Answer: Updated shots made by Pfizer and its partner BioNTech are authorized for anyone 12 and older, and rival Moderna's version is for adults. They're to be used as a booster for anyone who's already had their primary vaccination series -- using shots from any U.S.-cleared company -- and regardless of how many boosters they've already gotten.
Pfizer via AP
Answer: No. The FDA set the minimum wait time at two months. But advisers to the Centers for Disease Control and Prevention said it's better to wait longer. Some advise at least three months, another said someone who's not at high risk might wait as long as six months.
"If you wait a little more time, you get a better immunologic response," said CDC adviser Dr. Sarah Long of Drexel University.
That's because someone who recently got a booster already has more virus-fighting antibodies in their bloodstream. Antibodies gradually wane over time, and another shot too soon won't offer much extra benefit, explained Wherry, who wasn't involved with the government's decision-making.
Pfizer via AP
Answer: It's still important to get vaccinated even if you've already been infected -- but timing matters here, too.
The CDC has long told people to defer vaccination until they've recovered but also that people may consider waiting for three months after recovering to get a vaccination. And several CDC advisers say waiting the three months is important, both for potentially more benefit from the shot and to reduce chances of a rare side effect, heart inflammation, that sometimes affects teen boys and young men.
Pfizer via AP
Answer: That's not clear, because tests of this exact recipe have only just begun in people.
The FDA cleared the new boosters based in large part on human studies of a similarly tweaked vaccine that's just been recommended by regulators in Europe. Those tweaked shots target an earlier omicron strain, BA.1, that circulated last winter, and studies found they revved up people's virus-fighting antibodies.
With that earlier omicron version now replaced by BA.4 and BA.5, the FDA ordered an additional tweak to the shots — and tests in mice showed they spark an equally good immune response.
There's no way to know if antibodies produced by an omicron-matched booster might last longer than a few months. But a booster also is supposed to strengthen immune system memory, adding to protection against serious illness from the ever-mutating virus.
AP file
Answer: The basic ingredients used in both omicron-targeting updated vaccines are the same. Testing by Pfizer and Moderna of their BA.1-targeted versions proved safe in human studies and CDC's advisers concluded the additional small recipe change should be no different.
Flu vaccines are updated every year without human trials.
AP file
Answer: Yes, one in each arm.
AP file
Answer: People at high risk from COVID-19 are encouraged to get the new booster when they're due. After all, BA.5 still is spreading widely and hospitalization rates in older adults have increased since spring.
Most Americans eligible for an updated booster have gone at least six months since their last shot, according to the CDC — plenty of time that another shot should trigger a good immune response.
But the original formula still offers good protection against severe illness and death, especially after that all-important first booster. So it's not uncommon for younger and healthier people to time boosters to take advantage of a shot's temporary jump in protection against even a mild infection.
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.
AP Photo/Jae C. Hong, File
FILE - In this Aug. 28, 2021, file photo, Mayra Navarrete, 13, receives the Pfizer COVID-19 vaccine from registered nurse, Noleen Nobleza at a clinic set up in the parking lot of CalOptima in Orange, Calif.
