Pfizer and BioNTech request authorization for COVID-19 boosters for children aged 5-11

Pfizer and BioNTech have requested authorization from the Food and Drug Administration to give booster doses of their COVID-19 vaccine to children ages 5 to 11, the companies jointly announced on Tuesday.

The announcement comes about two weeks after the companies reported a third shot sparked a strong immune response in children in that age group. The phase 2/3 clinical trial found that the booster raised antibodies against the omicron variant thirty-sixfold compared to levels seen after two shots.

“Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine with no new safety signals,” the companies said.

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The Pfizer-BioNTech vaccine was determined by New York public health officials in February to be vastly less effective against infection from the coronavirus during the omicron surge. They reported that protection from infection in children ages 5 through 11 fell sharply from 68% to just 12% between Dec. 13, 2021, and Jan. 31, 2022, the height of the omicron wave.

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While a third 10-microgram dose of the vaccine was shown to produce immune responses in children 5 to 11, all children under five remain ineligible for any COVID-19 vaccine, frustrating some parents. Children, though, have proven less vulnerable to severe illness due to COVID-19, and hospitalizations among young children have remained far lower compared to older adults.

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