FDA authorizes use of Pfizer-BioNTech COVID vaccine for kids 12-15 years old
The U.S. Food and Drug Administration (FDA) has authorized the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12 to 15.
The FDA's Monday afternoon announcement opens the door for millions more Americans to become vaccinated, at a time when many states - including Minnesota - are eyeing a return to normalcy in the weeks ahead.
"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," Acting FDA Commissioner Janet Woodcock, M.D., said in a news release.
Before these teenagers start receiving the vaccine, a Centers for Disease Control and Prevention (CDC) committee must officially recommend the measure, which the CDC would then adopt, NBC Chicago explains. That committee is slated to have an emergency meeting Wednesday.
The FDA's emergency authorization of the Pfizer-BioNTech vaccine for young teens has been expected. During the clinical trial, none of the participants that received the vaccine were diagnosed with the virus.
The FDA notes that more than half of the participants were monitored for at least two months after received the second dose. The most common side effects were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. And just as with adults, participants reported side effects more after the second dose than the first.
The Moderna vaccine, meanwhile, recently announced its Phase 2 trial results showed 96% efficacy for those aged 12 to 17. That company is also seeking emergency authorization from the FDA for young teens.
Sixty (60) percent of Minnesotans aged 16-plus have received at least one shot, as of Monday, while 88% of the age-65-plus population has had at least one dose of a vaccine. Overall, 48% of the state's population has had at least one dose.