COVID bivalent booster for kids under 12 authorized by FDA – USA TODAY

Children ages 5 to 11 are now eligible to receive a COVID-19 booster aimed at both the original virus that causes COVID-19 and the omicron BA.4 and BA.5 variants.
The Food and Drug Administration authorized the boosters Wednesday morning from both Pfizer-BioNTech and Moderna, and the director of the Centers for Disease Control and Prevention gave a thumbs up on the shots several hours later.
The vaccines should soon become available at area pharmacies and pediatricians’ offices.
Children are less likely than adults to become severely ill and die of COVID-19 infections or to suffer from long COVID-19.
But that risk isn’t zero. Because COVID-19 vaccines have been found to be extremely safe, pediatricians strongly recommend that nearly all children receive the two-dose primary series as well as a booster.
“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19,” said Dr. Peter Marks, who heads the FDA’s vaccine division, in a statement. “We encourage parents to consider primary vaccination for children and follow up with an updated booster dose when eligible.” 
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White House COVID-19 coordinator Dr. Ashish Jha has urged everyone to get a bivalent booster shot by Oct. 31, ahead of the holidays and an expected winter surge in cases.
It takes about two weeks for vaccines to become fully effective after a shot.
“Don’t wait,” Jha said in a White House briefing Tuesday. “Get your new flu shot and get your new COVID shot today. If Americans did that, we could save hundreds of lives each day this winter.”
Adults are told to wait three months after an infection before getting a booster. Children are to wait at least two months after a previous infection or COVID-19 vaccine to get the booster, the FDA said.
While the first two vaccine doses were protective early in the pandemic, studies showed a third shot was needed to provide strong protection against severe disease from the omicron variant, which first appeared around last Thanksgiving.  
Officials have said it’s OK to get a COVID-19 booster at the same time as an annual flu shot.
Although a previous infection with COVID-19 is believed to be protective against re-infection, as with vaccines, that protection isn’t perfect and fades over time, particularly in the face of new variants. 
The new shot is considered a “bivalent” vaccine, because it targets both the original virus and the variants that have been most common since early summer.
BA.4 and BA.5 now account for about 80% of the variants seen in the United States, a figure that has fallen in recent weeks. BA.4.6 is now the second-most common variant (BA.5 is first), and BA.7 is gaining ground as well. It’s not clear whether vaccines and treatments will respond differently to those newer variants.
Pfizer and its partner, BioNTech, said they are prepared to immediately ship the boosters, following final quality control checks. 
“Pfizer has the capacity to ship up to 6 million pediatric doses in the first seven calendar days,” company spokesperson Steve Danehy said in a statement, “without any impact to distribution output of the doses for individuals 12 years and older.”
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The new Pfizer-BioNTech booster is the same as the one available for older children and adults, just at a lower dose: 10 micrograms instead of the adult 30 microgram dose. The Moderna booster dose for children ages 6 to 11 is 25 micrograms. 
The Pfizer-BioNTech and Moderna boosters are considered equivalent, with no proven difference in terms of effectiveness or side effects for either one or for mixing vaccines. The Pfizer-BioNTech vaccine is available for children as young as 5, while Moderna’s is only available for kids as young as 6.
The companies have not yet completed clinical trials of the booster in younger children. The FDA decided the change to a bivalent vaccine is not likely to have a different effect or risk profile than the earlier shots. Flu vaccines are similarly altered annually to adjust to circulating variants without being tested in people.
Both the FDA and CDC decided the new boosters were not different enough from earlier vaccines to require input from their expert advisory panels.
They are the only two COVID-19 vaccines available for children ages 5 to 12 in the United States, although Novavax, whose vaccine is based on a different technology, has asked for permission to provide its vaccine as a primary series in that age group.
Pediatric experts reacted positively to the authorization.
“As a pediatrician, this is welcome news. It is essential that children remain up-to-date with their COVID-19 vaccinations for their own health and potentially to protect more vulnerable adults around them, especially as we head towards a potential surge of cases this winter,” said Dr. Julie Morita, executive vice president of the Robert Wood Johnson Foundation, via email. “The next steps are to ensure that all families – in particular, those with low incomes or without health insurance – have access to these updated vaccines and can get their questions answered from trusted sources.”
It’s not clear when or whether the booster will become available for even younger children. With Pfizer-BioNTech’s vaccine, they are already recommended to get three doses as their primary course, although Moderna’s vaccine is authorized for just two shots for children as young as 6 months.
Moderna said it expects to submit an application for a booster dose for the youngest children before the end of the year.
The organization Protect Their Future, which lobbies on behalf of young children’s health, is concerned about the lack of bivalent boosters for under-5s.
“Omicron continues to ravage our communities NOW, and just as adults and children over 5 are deemed worthy of receiving access to a safe vaccine that could help them through another winter surge, our youngest childrens’ health should be treated with the same care and value,” the organization wrote in an email.
Contributing: Adrianna Rodriguez
Contact Karen Weintraub at kweintraub@usatoday.com.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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