In an announcement made late Monday afternoon, the Food and Drug Administration announced it was including those aged 12 to 15 in the emergency use authorization for the Pfizer-BioNTech COVID vaccine.
Acting FDA Commissioner Janet Woodcock called the expanded clearance "a significant step in the fight against the COVID-19 pandemic," adding Monday's announcement is "bringing us closer to returning to a sense of normalcy and to ending the pandemic" and that "parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data" in making their decision.
Today, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of #COVID19 to include adolescents 12-15 years of age. FDA amended the EUA issued on Dec. 11, 2020 for administration in individuals 16 years of age and older. https://t.co/3ROLW8WXwL pic.twitter.com/d9zwg7BS4q— U.S. FDA (@US_FDA) May 10, 2021
Under the amended emergency use authorization, adolescents 12 to 15 years old will be eligible to receive the same dosage as those 16 and up following the same two-dose regimen given three weeks apart.
Data and findings from the clinical trials that preceded the FDA's decision were also released Monday afternoon:
"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."
Analysis of the Effectiveness of the vaccine in 12 to 15 year-olds found the immune response to be "at least as good as" seen in those 16 to 25 years old. The FDA also reported that "among participants without evidence of prior infection with SARS-CoV-2, no cases of COVID-19 occurred among 1,005 vaccine recipients and 16 cases of COVID-19 occurred among 978 placebo recipients," meaning the vaccine was 100% effective in preventing COVID-19."
In its announcement of the expanded authorization for the Pfizer vaccine the FDA notes "children and adolescents generally have a milder COVID-19 disease course as compared to adults" following months of forced distance learning due to unscientific school closures even though data showed little risk to students or educators.
As Katie noted back in February, the science has been settled for some time:
In July 2020, the Centers for Disease Control and Prevention (CDC) released data-based guidance showing the virus has an extremely low spread rate in schools and stated with mitigation efforts, schools could be reopened for in-person learning. In January 2021, the American Academy of Pediatrics produced a similar study showing the same results: schools are safe for teachers and students.