FDA expands use of Pfizer COVID-19 vaccine booster to include 12-15 year olds

The US Food and Drug Administration amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine today to expand the use of a single booster dose to include use in individuals 12 through 15 years of age.

The agency has determined that the protective health benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine outweigh the potential risks in individuals in this age group.

The FDA based its determination in part on a review of real-world data from Israel, including safety data from more than 6,300 individuals between ages 12 and 15, who received a booster dose at least 5 months following completion of the primary two-dose vaccination series. 

The FDA also amended the EUA to shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.

The amended EUA also allows for a third primary series dose for certain immunocompromised children 5 through 11 years of age.

“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” said Acting FDA Commissioner Janet Woodcock, M.D. in a press release update. “With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing to in order to effectively fight COVID-19.”

The fact sheets for recipients and caregivers and for healthcare providers contain information about the potential side effects, as well as the risks of myocarditis and pericarditis.

The FDA reports that the most commonly reported side effects by individuals who received a booster dose or an additional dose as part of a primary series were “pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills.” Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the second dose of a two-dose primary series, according to the FDA.

The amendment to the EUA was granted to Pfizer Inc.