Today the FDA expanded authorization for the Pfizer Vaccine to include youth ages 12 through 15. The previous emergency order only approved adults 16 and older.
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 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.”
The FDA concluded that the Pfizer COVID-19 vaccine met all criteria to amend the Emergency Use Authorization. The benefits of this vaccine in youth 12 and up outweigh the potential risks. While COVID-19 cases among younger adolescents typically have been milder, there have been more severe cases and even death reported from COVID-19 in this age group.
The most common side effects in the adolescent clinical trial were similar to those over 16. Pain at the injection site, tiredness, headache, chills, muscle pain, and fever were the most common side effects lasting 1-3 days. In the clinical trials, the Pfizer COVID-19 vaccine was proven 100% effective in preventing COVID.
The Pfizer COVID-19 vaccine is the first vaccine approved for teens and adolescents. President Biden has said it will quickly mobilize to vaccinate teens through the federal pharmacy program and family doctors. States ultimately decide on who gives out the vaccine and the period that happens.
Dr. Allison Arwardy, head of the City’s health department, said that in Chicago, communities with the lowest vaccination rates continue to have high case counts and rates of hospitalization and death—even in teens and young adults. Help us increase vaccine uptake and get past COVID by bringing your whole family to get vaccinated together.”
Vaccination sites plan to begin vaccinating adolescents and teens this Thursday. A parent or guardian must accompany the child to obtain the vaccine. COVID-19 vaccines are free regardless of insurance or immigration status.
Danielle Sanders is a writer and journalist living in Chicago. Find her on social media @DanieSandersOfficial.