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U.S. approves Pfizer-BioNTech COVID-19 for adolescents

Christian Fernsby |
The U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age.

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The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.

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 Centers for Disease Control and Prevention (CDC).

Children and adolescents generally have a milder COVID-19 disease course as compared to adults. The Pfizer-BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older.

The available safety data to support the EUA in adolescents down to 12 years of age, include 2,260 participants ages 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, so it is important for vaccination providers and recipients 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 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. Since its authorization for emergency use, rare severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine in some recipients.


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