(RxWiki News) The US Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for Pfizer-BioNTech's COVID-19 vaccine to include adolescents between the ages of 12 and 15.
Until this expanded approval, Pfizer-BioNTech's COVID-19 vaccine was only available for those who were 16 and older.
Now, young teens across the nation are being vaccinated.
According to the Centers for Disease Control and Prevention (CDC), about 1.5 million cases of COVID-19 were reported in 11- to 17-year-olds over the course of 13 months. The fact that a vaccine is now available to those under the age of 16 years old is a huge step in the fight against COVID-19, the agency noted.
This action allows for a younger population to be protected from COVID-19, bringing the 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,” said Acting FDA Commissioner Dr. Janet Woodcock in a press release.
In 12- to 15-year-olds, the vaccine will follow the same dosage approved for those who are 16 and older. The dose is two shots given three weeks apart.
An EUA is different from an FDA approval. In order to issue an EUA, the FDA evaluates the product for effectiveness and assesses whether the known and potential benefits of this vaccine outweigh the risks.
The vaccine was studied in 2,260 adolescents, according to the FDA. The most commonly reported side effects in clinical trials were pain at the injection site, tiredness, headache, chills, muscle and joint pain and fever, all of which typically lasted one to three days.
More individuals reported these side effects after getting the second dose than after the first dose (with the exception of pain at the injection site), the FDA noted.
If you have any questions about vaccine availability, speak with your pharmacist.