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Omicron-Specific Covid Boosters for Children Ages 5 to 11 Are ‘Only a Matter of Weeks Away,' Says FDA Vaccine Chief

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New omicron-specific Covid boosters for children ages 5 to 11 are "only a matter of weeks away," according to the U.S. Food and Drug Administration's vaccine chief. 

On Tuesday, Dr. Peter Marks said during an event with the Covid-19 Vaccine Education and Equity Project that he's "confident" the FDA will authorize the new shots for that age group soon, noting that vaccine manufacturers Pfizer and Moderna are in the process of submitting necessary data.

Marks added that an authorization for the youngest age group — kids under 5 — is still "a few months away." 

If the FDA does authorize the new boosters in the coming weeks, the Centers for Disease Control and Prevention said in a vaccination planning guide released Tuesday it expects to recommend the shots for some children in early to mid-October.

The CDC expects Pfizer's redesigned booster to be for children ages 5 to 11, and Moderna's to be for children ages 6 to 17.

The new boosters are bivalent, meaning they target the original Covid strain and omicron's BA.4 and BA.5 subvariants. 

Federal health officials say the shots will serve as an extra layer of protection that is badly needed during the fall and winter months, when immunity from previous vaccines wanes and people spend more time indoors where the virus can spread more easily.

Currently, children ages 5 to 11 are only eligible to receive Covid vaccines for their primary series, and a single monovalent booster dose from Pfizer. If the new bivalent boosters receive approval from the FDA and CDC, the monovalent boosters may no longer be authorized for the age group, according to the CDC's planning guide.

Here's what else you should know

Marks notes that many children ages 5 to 11 are still in the process of completing their primary Covid vaccination series — and will likely need to do so to be eligible for the updated boosters.

That's the case for adults: You're only eligible for the new shots if you've completed your primary vaccination series, and are at least two months out from your last dose of any Covid vaccine, according to the CDC.

Only about 31% of U.S. children — or  8.7 million —  in that age group have completed their two-dose primary vaccination series, according to data released last week from the American Academy of Pediatrics. 

Children under 5 have a similar low uptake: Only 8% of children 6 months to 4-years-old have received at least one dose of a primary series vaccine, AAP data showed. 

That's why "it's a good idea to think about getting your child vaccinated against Covid-19," according to Marks. "Enough children have received these vaccines now to know that these are safe, they are effective."

Dr. Sarah Meyer, chief medical officer of CDC's Immunization Services Division, also spoke at the Tuesday event alongside Marks. She emphasized that parents shouldn't wait to get their kids boosted: If a child is eligible for the existing booster shots authorized for their age group, they should get it now.

"We want to encourage everybody to stay up to date on their vaccines, including children, because you just never know when ... you might be exposed or when you might get sick," Meyer said shortly after Marks spoke. "We know that children are getting sick. They're going to the hospital and there are sadly children who have died from Covid."

Just over 60,000 Covid cases in children were reported during the week that ended on Sept. 15, which represents about 18.5% of the weekly cases reported in the U.S., according to the AAP.

From 2020 to 2022, 1,282 children ages 17 and under have died from Covid, according to the latest CDC data.

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