FDA Authorizes Pfizer-BioNTech Vaccine for Emergency Use in Adolescents

WASHINGTON – The U.S. Food and Drug Administration announced Monday the Pfizer-BioNTech vaccine has been approved for emergency use for adolescents ages 12 to 15 years of age. 

“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,” said Acting FDA Commissioner Janet Woodcock, M.D. 

The FDA has determined that Pfizer-BioNTech COVID-19 vaccine has met the statutory criteria to amend the emergency use authorization, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population. 

The emergency use authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated and may be revised or revoked if it is determined the emergency use authorization no longer meets the statutory criteria for issuance or to protect public health or safety. 

The available safety data to support the emergency use authorization in adolescents down to 12 years of age, includes 2,260 participants ages 12 through 15 years old enrolled in an ongoing randomized, placebo-controlled clinical trial in the U.S. 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 immune response of adolescents was at least as good as the immune response of the older participants. An analysis of cases of COVID-19 occurring among participants, 12 through 15 years of age, seven days after the second dose was also conducted. 

The vaccine was 100% effective in preventing COVID-19, as 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. 

From March 1, 2020, through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention.  

Children and adolescents generally have a milder COVID-19 disease course as compared to adults. 

“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,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. 

The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers)  and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine. 

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. 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. 

Since its authorization for emergency use, rare severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 vaccine in some recipients, as such the vaccine should not be given to anyone with known history of severe allergic reaction, including anaphylaxis.