Pfizer says its COVID-19 vaccine works for kids ages 5 to 11

Pfizer said Monday its COVID-19 vaccine works for children ages 5 to 11 and that it will seek U.S. authorization for this age group soon.

The vaccine made by Pfizer and its German partner BioNTech already is available for anyone 12 and older. But with kids now back in school and the extra-contagious delta variant causing a huge jump in pediatric infections, many parents are anxiously awaiting vaccinations for their younger children.

"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children," said Pfizer CEO Albert Bourla.

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For elementary school-aged kids, Pfizer tested a much lower dose -- a third of the amount that’s in each shot given now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press.

"The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose," said Dr. Ugur Sahin, CEO and co-founder of BioNTech.

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While kids are at lower risk of severe illness or death than older people, more than 5 million children in the U.S. have tested positive for COVID-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics. Cases in children have risen dramatically as the delta variant swept through the country.

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Pfizer said it studied the lower dose in 2,268 kindergartners and elementary school-aged kids. The FDA required what is called an immune "bridging" study: evidence that the younger children developed antibody levels already proven to be protective in teens and adults. That's what Pfizer reported Monday in a press release, not a scientific publication. The study still is ongoing, and there haven't yet been enough COVID-19 cases to compare rates between the vaccinated and those given a placebo — something that might offer additional evidence.

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The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. The FDA’s Marks said the pediatric studies should be large enough to rule out any higher risk to young children. Pfizer’s Gruber said once the vaccine is authorized for younger children, they’ll be carefully monitored for rare risks just like everyone else.

A second U.S. vaccine maker, Moderna, also is studying its shots in elementary school-aged children. Pfizer and Moderna are studying even younger tots as well, down to 6-month-olds. Results are expected later in the year.

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The news comes days after a U.S. Food and Drug Administration (FDA) advisory panel on Friday endorsed emergency approval for the Pfizer-BioNTech COVID-19 vaccine booster shot at least six months following the second dose among people ages 65 and older and those at high risk of occupational exposure and severe COVID-19.

The vote was 18-0. The vote will now go before the FDA to issue a final decision.

The panel earlier Friday afternoon voted to reject licensure of Pfizer's booster vaccine in people ages 16 and older, at a vote of 2-16.

Fox News' Kayla Rivas and The Associated Press contributed to this report