FDA Authorizes BNT162b2 Covid Boosters for Kids Ages 5-11

The FDA moved to amend the emergency use authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine, BNT162b2, to allow for a single booster dose in kids ages 5-11 years old.

The 10-μg booster dose is now authorized for administration in this age group at least 5 months after completing a primary two-dose vaccination series with the BNT162b2 vaccine, the agency explained. The FDA opted to skip convening its Vaccines and Related Biological Products Advisory Committee to discuss this decision, after concluding that the manufacturer’s request "did not raise questions that would benefit from additional discussion by committee members."

"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 M. Califf, MD, in a statement. "…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."

This EUA amendment was based on immune response data on a subset of pediatric patients from an ongoing randomized, placebo-controlled, phase II/III trial evaluating the efficacy of a 10-μg booster in the 5-11 year age group, findings from which were reported by the manufacturer in April of this year.

"Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech Covid-19 Vaccine," the FDA wrote. "The antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose."

The agency also examined safety data on the booster dose in approximately 400 patients ages 5-11 who got the additional shot at 5-9 months after their initial vaccine series. Side effects were consistent with those seen in previous trials, including pain, redness, and swelling at the injection site, fatigue, headache, muscle or joint pain, and chills/fever.

The FDA previously authorized a single booster dose of BNT162b2 for adolescents ages 12-15 in January 2022. The fully approved version of the BNT162b2 vaccine, currently indicated for use in patients ages 16 years and older, is marketed by Pfizer-BioNTech as Comirnaty.