Pfizer COVID-19 Vaccine Can be Used in Adolescents, FDA Says

May 11, 2021 - FDA recently expanded the emergency use authorization for the Pfizer COVID-19 vaccine to include adolescents 12 through 15 years of age.

The agency amended the original emergency use authorization from December, which was intended for individuals 16 years of age and older.

“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,” Acting FDA Commissioner Janet Woodcock, MD, said in the announcement. 

“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,” Woodcock continued. 

FDA based its decision on data from a Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. 

Results trial, which were announced at the end of March, showed a vaccine efficacy of 100 percent in participants with or without prior COVID-19  infection and robust antibody responses. 

Additionally, the vaccine was also generally well tolerated.

Overall, FDA determined that the COVID-19 vaccine met statutory criteria to amend the emergency use authorization and that the known and potential benefits of the vaccine in individuals 12 years of age and older outweigh the known and potential risks.

From March 2020 to April 2021, nearly 1.5 million COVID-19 cases in individuals 11 to 17 years of age were reported to the CDC. 

Generally, children and adolescents have milder COVID-19 cases compared to adults. A March JAMA Network Open study found that there are distinct COVID-19 antibody response profiles that vary based on age. 

The cross-sectional study used 31,426 COVID-19 antibody test results from pediatric and adult patients between April and August 2020. The data was taken from New York-Presbyterian Hospital/Weill Cornell Medical Center.

Immunoglobulin G (IgG) levels, total antibody levels, and surrogate antibody activity were compared between children between 1 and 10 years old, adolescents 11 to 18 years old, and young adults 19 to 24 years old.

Overall, researchers found that younger children exhibited higher levels of IgG, total antibody level, and surrogate antibody activity than adolescents and young adults.

Specifically, COVID-19 IgG level showed a negative correlation with individuals in the pediatric population and a moderate but positive correlation in adult patients. Young adults showed the lowest IgG levels. 

Following the emergency use authorization expansion, FDA updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers to reflect the use of the vaccine in the adolescent population.

The information includes the benefits and risks of the Pfizer-BioNTech COVID-19 vaccine.

“Today’s expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents before the start of the next school year,” Albert Bourla, chairman and chief executive officer at Pfizer, said in a statement following the expanded authorization.

“We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world,” Bourla continued.