The U.S. Food and Drug Administration (FDA) announced the expansion of the Emergency Use Authorization (EUA) for the mRNA Phizer-BioNTech COVID-19 Vaccine (Comrinaty) to include adolescents 12 through 15 years of age. This EUA was originally issued on December 11, 2020, for administration in individuals 16 years of age and older.
Acting FDA Commissioner Janet Woodcock, M.D., said in a press statement issued on May 10, 2021, “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
From March 1, 2020, through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the US Centers for Disease Control and Prevention.
However, children and adolescents generally have very mild COVID-19 disease course as compared to adults.
The available safety data to support the EUA in adolescents down to 12 years of age, including 2,260 participants ages 12 through 15, 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, so vaccination providers and recipients need to expect that there may be some side effects after either dose, but even more so after the second dose. The side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older.
It is important to note that as a general matter, 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 EUA amendment was issued to Pfizer Inc. The issuance of an EUA is not an FDA Approval (licensure) of a vaccine.