- The new vaccine for children targets both the original virus that causes COVID-19 and the omicron BA.4 and BA.5 variants.
- Vaccines should quickly be available in pharmacies and pediatricians’ offices in the region.
- White House COVID-19 coordinator Dr Ashish Jha has urged everyone to get a bivalent shot by October 31, ahead of the holidays and an expected winter surge.
Children ages 5-11 can now receive a COVID-19 booster for both the original virus that causes COVID-19 and the omicron BA.4 and BA.5 variants.
The Food and Drug Administration allowed boosters On Wednesday morning, both Pfizer-BioNTech and Moderna, and the director of the Centers for Disease Control and Prevention gave the thumbs up to the snaps several hours later.
Vaccines should soon be available in pharmacies and pediatricians’ offices in the region.
Children are less likely than adults to become seriously ill and die from COVID-19 infections or to suffer from long COVID-19.
But this risk is not zero. Because COVID-19 vaccines have been shown to be extremely safe, pediatricians strongly recommend that almost all children receive the two-dose primary series as well as a booster.
“Since children have returned to in-person school and people are resuming their pre-pandemic behaviors and activities, there is an increased risk of exposure to the virus that causes COVID-19,” said Dr Peter Marks , which heads the FDA. vaccines division, in a statement. “We encourage parents to consider the primary vaccination for children and to 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 vaccine by October 31, ahead of the holidays and an expected spike in winter cases.
It takes about two weeks for vaccines to become fully effective after an injection.
“Don’t wait,” Jha said during a White House briefing on Tuesday. “Get your flu shot and get your COVID shot today. If Americans did, we could save hundreds of lives every day this winter.”
Adults are told to wait three months after an infection before getting a booster. Children must wait at least two months after a previous infection or a COVID-19 vaccine to receive the booster, the FDA said.
While the first two doses of the vaccine provided protection early in the pandemic, studies have shown that a third injection was needed to provide strong protection against the severe omicron variant disease, which first emerged around last Thanksgiving.
Officials said it was OK to get a COVID-19 reminder along with an annual flu shot.
Although prior infection with COVID-19 is believed to protect against reinfection, as with vaccines, this protection is not perfect and fades over time, especially in the face of new variants.
The new vaccine is considered a “bivalent” vaccine, since it targets both the original virus and the most common variants since the beginning of the summer.
BA.4 and BA.5 now represent about 80% of the variants seen in the United States, a figure that has been declining in recent weeks. BA.4.6 is now the second most common variant (BA.5 is the first), and BA.7 is also gaining ground. It is not clear whether vaccines and treatments will react differently to these new variants.
Pfizer and its partner, BioNTech, said they were ready to ship the boosters immediately after final quality checks.
“Pfizer has the capacity to ship up to 6 million pediatric doses in the first seven calendar days,” company spokesman Steve Danehy said in a statement, “with no impact on the distribution of doses for persons 12 years of age and older”.
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The new Pfizer-BioNTech booster is the same one available for older children and adults, but at a lower dose: 10 micrograms instead of the adult dose of 30 micrograms. The Moderna booster dose for children 6 to 11 years old is 25 micrograms.
Pfizer-BioNTech and Moderna boosters are considered equivalent, with no proven difference in efficacy or side effects for either or the combination of vaccines. The Pfizer-BioNTech vaccine is available for children as young as 5 years old, while Moderna’s vaccine is only available for children as young as 6 years old.
The companies have not yet completed clinical trials of the booster in young children. The FDA has decided that switching to a bivalent vaccine is unlikely to have a different effect or risk profile than previous injections. Flu vaccines are modified in the same way every year to adapt to the variants in circulation without being tested on humans.
The FDA and CDC both decided that the new boosters were not different enough from previous vaccines to warrant input from their expert advisory groups.
These are the only two COVID-19 vaccines available for children aged 5 to 12 in the United States, although Novavax, whose vaccine is based on a different technology, has requested permission to provide its vaccine as a primary series in this age group.
Pediatric experts reacted positively to the clearance.
“As a pediatrician, this is good news. Keeping children up to date on their COVID-19 vaccinations is essential for their own health and potentially to protect the more vulnerable adults around them, especially that we are heading for a possible increase in 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 – especially 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 unclear when or if the booster will be available for even younger children. With Pfizer-BioNTech’s vaccine, they are already recommended to receive three doses as their primary treatment, although Moderna’s vaccine is only licensed for two shots for children as young as 6 months.
Moderna said it plans to submit a request for a booster dose for younger children before the end of the year.
The Protect Their Future association, which campaigns for the health of young children, is concerned about the lack of bivalent boosters for children under 5 years old.
“Omicron continues to ravage our communities NOW, and just as adults and children over the age of 5 are deemed worthy of access to a safe vaccine that could help them through another winter surge, the health of our youngest children should be treated with the same care and value,” the organization wrote in an email.
Contributor: Adrianna Rodriguez
Contact Karen Weintraub at kweintraub@usatoday.com.
Coverage of patient health and safety 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.