Late Monday, the U.S. Food and Drug Administration (FDA) announced that the COVID-19 vaccine from Pfizer-BioNTech could be used on children ages 12 to 15, making yet another crucial demographic eligible for the shot and taking another step toward ending the coronavirus pandemic.
In a statement the FDA shared about the expansion of the Emergency Use Authorization (EUA), acting FDA Commissioner Janet Woodcock, M.D. 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.”
Per the agency, there have been approximately 1.5 million cases of COVID-19 in individuals 11 to 17 and, while children and teens generally have milder experiences with COVID019 than adults, they believe the benefits of giving kids 12 and up the vaccine are made it worth giving it EUA. The vaccines are set to be administered the same way they have been for adults: in a series of two doses, three weeks apart.
“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said in a statement. “With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”
COVID-19 vaccine safety, so far — here’s what we know
As SheKnows has previously reported, the Pfizer/Biotech vaccine is an mRNA vaccine (like the one from Moderna — both entirely different from the Johnson & Johnson vaccine) and thus far been cleared for and recommended for adults (including elderly, pregnant and breastfeeding adults). Per the CDC, mRNA vaccines “teach our cells how to make a protein—or even just a piece of a protein—that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies” instead of other vaccines that put weakened or inactive germs into our bodies to trigger an immune response.
In the available data on the safety of the vaccine, the FDA reported that they studied 2,260 participants in the age group in a randomized, placebo-controlled clinical trial with 1,131 adolescents receiving the vaccine. Of that number, more than half were followed for safety for at least two months after their second dose and the most common side effect reported were comparable to those experienced by adults: pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain lasting for one to three days, most often experienced after the second dose. They note that the Pfizer-BioNTech vaccine shouldn’t be given to anyone with a known history of a severe allergic reaction (including anaphylaxis) to any component of the vaccine.
“The side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older,” Per the FDA. “It is important to note that as a general matter, while some individuals experience side effects following any vaccination, not every individual’s experience will be the same and some people may not experience side effects.”
Looking for child-friendly face masks? This kids face mask gallery is a good place to start shopping!