Pfizer Submits Application for Emergency Use Authorization of COVID Booster for Kids 5 to 11

Getty A child getting a COVID-19 vaccine dose

Pfizer and BioNTech announced on Tuesday they have submitted an application to the U.S. Food and Drug Administration for emergency use authorization of a booster dose of their coronavirus vaccine for children ages 5 to 11.

The companies said in a press release that data showed that children under 12 had a "strong immune response" from a booster dose. A third booster shot after six months is believed to raise Omicron-fighting antibodies by 36 times.

Earlier this month, Pfizer released data from their lab study of a third dose.

In the study, 140 subjects between the ages of 5 and 11, with no evidence of prior COVID-19 infection, were given a third 10-microgram dose of the Pfizer-BioNTech vaccine at least six months after their second dose of the shot.

One month later, a subset of 30 test subjects showed that the Omicron-fighting antibodies had increased 36-fold. Pfizer and BioNTech noted that "a robust response was observed regardless of prior SARS-CoV-2 infection."

In general, antibody levels against the original COVID-19 strain were six times higher one month after a booster was administered compared to the month after a second vaccine dose to the 140 test subjects.

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Pfizer and BioNTech's first two doses of the COVID-19 vaccine received emergency approval from the U.S. Food and Drug Administration for children ages 5 to 11 years old in November 2021.

Tuesday's application to the FDA comes just as a new study from the Centers for Disease Control found that most Americans had been infected with COVID at least once.

Using data from blood tests taken around the country, the CDC determined that 33.5% of Americans had COVID-19 antibodies that developed from infection, and not vaccination, in Dec. 2021. By Feb. 2022, that percentage had jumped significantly, up to 58%.

The biggest increase was in kids under 18 — by February, 75%, or 3 in 4 kids, had COVID-19 antibodies in their system.

"By February 2022, evidence of previous Covid-19 infections substantially increased among every age group," Dr. Kristie Clarke, a CDC researcher who led the study, said at a press briefing.

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