FDA Expands Pfizer-BioNTech COVID-19 Vaccine for Adolescents 12-15 Years Old

The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) granted to Pfizer-BioNTech, allowing the companies’ COVID-19 vaccine for administration in persons aged 12-15 years old.

The expanded EUA granted to the two-dose mRNA vaccine BNT162b2 comes 6 months after it had become the first authorized COVID-19 vaccine for adults in the US in December 2020.

It also comes just days after news that Pfizer-BioNTech would pursue a Biologics License Application (BLA) for the vaccine, which would expand its availability and marketability in the US healthcare system.

Since March 2020 through April of this year, approximately 1.5 million COVID-19 cases have been reported to the Centers for Disease Control and Prevention (CDC), the FDA noted in its statement today. Though children and adolescents are generally subjected to milder forms of COVID-19 compared to adults, the EUA expansion marks a new threshold for immunization rate opportunity and likelihood of pandemic mitigation.

“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,” acting FDA commissioner Janet Woodcock, MD, said in a statement. “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.”

The EUA expansion was OKed on the basis of determination that BNT162b2 met statutory criteria indicating the vaccine’s benefits outweighed known and potential risks in the younger population.

Effectiveness data in patients aged 12-15 years old showed the vaccine provided a noninferior immune response among 190 participants of the age group, when compared to 170 participants aged 16-25 years old, 7 days following the second mRNA dose.

An analysis of cases among COVID-19-naïve, vaccinated participants aged 12-15 years old showed no cases of COVID-19 occurred among 1005 recipients, versus 16 cases among 978 placebo recipients.

Available safety data supporting the new EUA showed the most commonly reported adverse events among 1131 vaccinated adolescents included injection site, tiredness, headache, chills, muscle pain, fever and joint pain, 1-3 days following administration.

According to the FDA, the adverse events reported in adolescents were consistent with those reported in clinical trial participants aged 16 years of age and older.

As of Monday evening, 262 million total vaccine doses had been administered in the US, according to the CDC. Breaking ground on availability for a younger population is a “critical step” in the continued fight against the pandemic, Peter Marks, MD, PhD, 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,” Marks said.