FDA authorizes Pfizer-BioNTech COVID-19 vaccine booster for children 5 to 11 years old

The United States Food and Drug Administration has authorized booster shots for children aged five to 11, deeming them safe and effective for those in the age group who received their original dose at least five months prior.

“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,” said FDA Commissioner Robert M. Califf, M.D. in a  . “Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe.”

The emergency use authorization (EUA) came after the FDA authorized a single dose of the Pfizer-BioNTech COVID-19 vaccine for children 12 through 15 in January of 2022.

The FDA’s decision came after researchers studied results from a Centers for Disease Control and Prevention (CDC) randomized placebo-controlled trial of children who received a Pfizer-BioNTech COVID-19 booster. When researchers analyzed a subset of children who were aged 5 to 11, they found that 67 participants had elevated antibody responses against COVID-19 and 31 percent of children had a reduced risk of infection from the highly infectious COVID-19 variant, Omicron.

In addition, the safety of the booster in children of this age group were assessed in 400 children who received the booster at least five months after their original doses. Results showed that the most common side effects were redness, pain, and swelling at the injection site, in addition to, fatigue, muscle and joint pain, headache, chills, and fever.

“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.