By Alice Seeley

The U.S. Food and Drug Administration (FDA) announced on May 17 that it amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, authorizing the use of a single booster dose for administration to children 5 through 11 years of age. Children will be eligible for booster shots five months after completing a primary series with the Pfizer-BioNTech COVID-19 vaccine.

The FDA’s decision is intended to help provide continued protection against COVID-19 among children. The booster shot is 10 micrograms, the same dosage as the primary series for the age group and a third of the dosage given to people ages 12 and up.

FDA Commissioner Robert M. Califf acknowledged that COVID-19 is not as severe in children but stated, “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.”

The FDA made its decision by analyzing immune response data in a subset of children from an ongoing randomized placebo-controlled trial that supported the Oct. 2021 authorization of the Pfizer-BioNTech primary series in children from 5 through 11 years old. The safety of a single booster dose of the vaccine in children ages 5 through 11 was assessed in 400 children, with side effects including redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stated that the FDA has determined that the positive results of a booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years “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.”

The FDA’s decision will now go to the Centers for Disease Control and Prevention, which will make a recommendation about how the boosters should be used for the age group. The CDC’s Advisory Committee on Immunization Practices will discuss the booster during its scheduled meeting on Thursday, May 19. CDC Director Dr. Rochelle Walensky is expected to issue a final recommendation following that meeting, which means shots could begin as early as Friday, May 20. According to data from the CDC, less than a third of the 28 million 5 -to-11-year-old children in the United States have received two doses of a COVID vaccine.