U.S. Food and Drug Administration (FDA) on Monday authorized the emergency use of Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 for the prevention of COVID-19 vaccine caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the emergency use authorization (EUA), and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, FDA said in a news released posted on its website on Monday.
According to the available safety data uploaded by FDA, 2,260 participants aged 12 through 15 years old enrolled in an ongoing randomized, placebo-controlled clinical trial in the United States. Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo. More than half of the participants were followed for safety for at least two months following the second dose.
The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose. The side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older.
FDA further noted that while some individuals experience side effects following any vaccination, not every individual's experience will be the same and some people may not experience side effects.
The Pfizer-BioNTech COVID-19 Vaccine should not be given to anyone with a known history of a severe allergic reaction, including anaphylaxis to any component of the vaccine, FDA stressed.
The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The issuance of an EUA is not an FDA approval (licensure) of a vaccine. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated, and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance or to protect public health or safety, the news release said.
