FDA Updates Pfizer-BioNTech COVID-19 Vaccine EUA for Children Ages 12 and Older

Officials with the FDA have updated the emergency use authorization for Pfizer and BioNTech’s COVID-19 vaccine, allowing it to be used in children 12 to 15 years of age. The vaccine was previously approved for children and adults 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,” said acting FDA Commissioner Janet Woodcock, MD, in a press release. “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.”

The approval is supported by a phase 3 trial of 2260 Americans between 12 and 15 years of age. Investigators found that the vaccine showed 100% efficacy and robust antibody responses in this population, with the levels of efficacy exceeding those recorded in earlier studies of participants aged 16 to 25 years.

“Across the globe, we are longing for a normal life. This is especially true for our children,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in a press release. “The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the B.1.1.7 UK variant. It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones.”

Among the 1129 study participants, researchers observed 18 cases of COVID-19 among the placebo group compared to no cases among the vaccinated group. Furthermore, in those who were vaccinated, the vaccine induced SARS-CoV-2-neutralizing antibody geometric mean titers (GMTs) of 1239.5, demonstrating a strong level of immunogenicity in a subset of adolescents 1 month following the second dose.

An earlier analysis in participants aged 16 to 25 years found GMTs of 705.1, meaning the adolescent population GMTs were non-inferior in comparison to this older population. Adverse effects in the younger population were also consistent with those observed in older participants.

Research is also ongoing in children ages 6 months to 11 years, with first doses administered in March 2021 in a global phase 1/2/3 seamless study. This study is evaluating the safety, tolerability, and immunogenicity of the vaccine on a 2-dose schedule in 3 age groups: children aged 5 to 11 years, 2 to 5 years, and 6 months to 2 years. Vaccinating these younger groups could be key to achieving herd immunity in the United States, with a significant proportion of the population in these age groups.

Albert Bourla, DVM, PhD, chairman and chief executive officer of Pfizer, said they hope to begin vaccinating adolescents between 11 and 15 years of age by the beginning of the next school year.

“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Bourla said in the press release.

REFERENCE

Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents [news release]. Pfizer; March 31, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal. Accessed May 7, 2021.