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The US Food and Drug Administration expanded the emergency use authorization of the 2-dose vaccine to include children aged 12 to 15 years.
The US Food and Drug Administration (FDA) expanded the emergency use authorization for the 2-dose Pfizer/BioNTech COVID-19 vaccine to allow administration of the vaccine to children aged 12 to 15 years.1
The expanded authorization was based on data released by the company in March that showed the vaccine to be highly effective in the population. In the trials, the most common side effects were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain, and typically lasted for 1 to 3 days. Additionally, more side effects were reported after the second dose than the first dose. If a child has a known history of severe allergic reaction, including anaphylaxis, to any vaccine component, they should not receive the Pfizer/BioNTech vaccine due to the rare severe allergic reactions that have been reported in the past several months.
In the press release for the expansion, Acting FDA Commissioner Janet Woodcock, MD, said, “The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic. 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.”
States will be announcing their roll-out plans in the coming days and weeks.
1. US Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic. Published May 10, 2021. Accessed May 11, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use