FDA Expands EUA for Pfizer/BioNTech COVID-19 Booster to Children 5 to 11 Years

The FDA has amended the emergency use authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age. The booster is given at least five months after completion of a primary series and is the same dose of the Pfizer-BioNTech COVID-19 vaccine.

To date, more than 8 million 5- to 11-year-olds in the United States have completed a primary series, and 4,500 children this age have participated in the companies’ COVID-19 vaccine clinical trial, according to a press release issued by Pfizer.

Robert M. Califf, M.D.

“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,” FDA Commissioner Robert M. Califf, M.D., said in a press release.

The expanded EUA is based on data from the phase 2/3 clinical trial, which showed that a booster dose of the Pfizer-BioNTech COVID-19 vaccine elicited a strong immune response in this age group, generating neutralizing antibodies against both the omicron variant and wild-type SARS-CoV-2 virus regardless of prior SARS-CoV-2 infection. No new safety signals were observed.

The safety of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine in this age group was assessed in about 400 children who received a booster dose at least five months (range 5 to 9 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.

The companies have already submitted an application to the European Medicines Agency for a booster dose in this age group and are planning to file with other regulatory agencies around the world.

The vaccine is authorized for use as a two-dose primary series for those 5 years and older, and a three dose primary series for those with certain kinds of immunocompromise. The vaccine is also authorized as a single booster for those 5 years and older, and as a second booster for those 50 years and older and as a second booster for those 12 years and older with certain immunocompromise.