FDA approves COVID-19 vaccine booster for children ages 5 through 11

Pfizer-BioNTech gets emergency use authorization “and it is safe,” FDA chief says.

The U.S. Food and Drug Administration (FDA) has authorized the Pfizer-BioNTech COVID-19 vaccine booster dose for children ages 5 through 11.

The vaccine should come at least five months after completion of the primary series with the same vaccine, according to FDA’s amended emergency use authorization (EUA).

FDA is authorizing booster shots to provide continued protection against the COVID-19 pandemic, FDA Commissioner Robert M. Califf, MD, said in a news release.

“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,” Califf said.

“Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe,” Califf said. “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.”

Review process

The May 17 authorization for vaccines for children follows the Jan. 3 FDA authorization of using a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for individuals 12 through 15 years of age after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine.

The FDA did not hold a meeting of its Vaccines and Related Biological Products Advisory Committee on the May 17 action because the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines. After review of Pfizer’s EUA request, FDA leaders concluded that the request did not raise questions that would benefit from additional discussion by committee members.

Relevant documents will be available on the FDA website, the agency said.

Immune response data

The EUA for a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age was based on FDA’s analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial that supported the October 2021 authorization of the Pfizer-BioNTech COVID-19 vaccine primary series in that age group. Antibody responses were evaluated in 67 study participants who received a booster dose seven to nine months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The antibody level against the SARS-CoV-2 virus one month after the booster dose was increased, compared to before the booster dose.

Vaccine safety

The safety of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine in the 5 to 11 age group was assessed in about 400 children who received a booster dose at least five months, and up to nine months, after completing a two-dose primary series. The most commonly reported side effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills and fever, according to FDA.

“The Pfizer-BioNTech COVID-19 Vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the press release. “Since authorizing the vaccine for children down to 5 years of age 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 has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” Marks said.