FDA authorizes Pfizer’s COVID-19 booster shot for 5- to 11-year-olds

The U.S. Food and Drug Administration on Tuesday authorized a booster shot of the Pfizer-BioNTech vaccine for children ages 5-11.

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The booster will increase the level of neutralizing antibodies against the original version of the virus and the omicron variant, the company told the FDA last month.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” FDA Commissioner Dr. Robert M. Califf, said in a statement.

“The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19. Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death,” Califf added.

The agency authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 last October. A Pfizer booster shot for those ages 12 and above was authorized by the FDA on Jan. 3.

According to the Centers for Disease Control and Prevention, only 28.8% of children ages 5-11 have received two doses of the vaccine. Around 6% have received one shot.

Anyone age 12 and older in the U.S. is eligible for a booster shot at least five months after their second COVID-19 vaccination. So far, a vaccine for infants through age 5 has not been approved for use.

According to the CDC, a meeting of external vaccine experts on the Advisory Committee on Vaccine Practices has been scheduled for Thursday.

Following that meeting, CDC Director Dr. Rochelle Walensky is expected to issue her recommendation on the shot.