The US Food and Drug Administration has authorized the use of the Pfizer-BioNTech vaccine for emergency use on children between the age of 12 to 15 years.
After a long wait, the FDA has finally approved the vaccine for its use in adolescents. This makes the vaccine first among the COVID vaccines to get approved for the people of that age group.
The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the emergency use authorization (EUA).
In a news release posted on its website Monday, FDA said that the potential benefits of the Pfizer vaccine outweigh its risks.
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.
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. Except for 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.