FDA OKs Booster of Pfizer-BioNTech COVID-19 Vaccine for Kids Five to 11

The FDA has authorized a single booster of the Pfizer-BioNTech COVID-19 vaccine for children age five through 11 years.

On Tuesday, the agency expanded the vaccine’s emergency use authorization (EUA) to children in the five- to 11-year age group who are at least five months past completion of their primary series of the Pfizer-BioNTech COVID-19 jab(s). This gives access to the booster to about 28 million children.

“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,” said FDA Commissioner Robert Califf, in a statement.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), added that since authorizing the vaccine for children down to age five in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations.

The FDA said this expansion of the booster’s EUA is based on the agency’s analysis of immune response data in a subset of children from Pfizer and BioNTech’s ongoing trial that supported the October 2021 authorization of the vaccine in this age group.

Antibody responses were evaluated in 67 study participants who got a booster dose seven to nine months after finishing a two-dose primary series. The antibody level against COVID-19 one month after the booster dose was increased compared to before the booster dose, said the FDA.

The safety of a single booster dose was assessed in approximately 400 children. The most commonly reported side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain and chills and fever.

The FDA said it didn’t hold a meeting of its Vaccines and Related Biological Products Advisory Committee on the expansion of the vaccine’s EUA as it “concluded that the request did not raise questions that would benefit from additional discussion by committee members.”

If approved by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices following its Thursday meeting, the booster would be the same 10-microgram dose as the two-shot series the children got initially. That dosage is one-third the amount children age 12 and older get.

On Jan. 3, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children age 12 to 15. The agency authorized the Pfizer-BioNTech vaccine in children age five and older in October when studies showed it to be 90.7 percent effective at preventing symptomatic COVID-19.

The companies say they have already submitted an application to the European Medicines Agency for a booster dose in the five- to 11-year-old age group and are planning to file with other regulatory agencies around the world. — Suz Redfearn