On May 10, 2021, FDA authorized the emergency use of the Pfizer vaccine for children after having conducted clinical trials on it since October 2020.
The Centre for Disease Control and Prevention (CDC) reported around 1.5 million COVID-19 cases in adolescents of 11 to 17 years of age in the last year. The U.S. Food and Drug Administration (FDA) amended the Emergency Use Approval (EUA) granted on December 11, 2020, for administration in people over 16. On May 10, 2021, Pfizer and the FDA published a press release that authorized the use of the vaccine in adolescents (12-15 years).
The clinical data supporting the EUA in adolescents included 2,260 participants ages 12 to 15 years old who were enrolled in a randomized, placebo-controlled clinical trial in the United States. The vaccine was administered to 1,131 adolescent participants, while 1,129 received a saline placebo. Participants who remained in the study were monitored for safety for at least two months after the second dose.
In the press release, FDA Commissioner Janet Woodcock said that the extension to adolescents from 12-15 years for the Pfizer-BioNTech vaccine is an important step forward against COVID-19.
Pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain were the most commonly reported side effects in adolescent clinical trial participants, typically lasting 1-3 days. According to the Pfizer press release, CDC and Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommendations for using the vaccine in adolescents 12 to 15 years of age based on the amended EUA.
The COVID-19 pandemic has given rise to a lot of potentially dangerous misinformation. For reliable advice on COVID-19 including symptoms, prevention and available treatment, please refer to the World Health Organisation or your national healthcare authority.