The Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for the administration of a single booster dose to individuals 16 and 17 of age at least 6 months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 vaccine.

As the Pfizer-BioNTech COVID-19 vaccine is the only COVID-19 vaccine authorized for use in 16- and 17- year-olds, individuals in this age group should only receive this vaccine as their booster.

“Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “A single booster dose of the vaccine for those vaccinated at least 6 months prior will help provide continued protection against COVID-19 in this and older age groups.”

Evidence supporting the effectiveness of the booster dose in individuals 16 and 17 years of age was based on available data in adults 18 years of age and older. Data demonstrating waning neutralizing antibody titers approximately 6 months after completion of the primary series, particularly against variants of concern, have indicated a need for a booster dose to maintain a high level of protection.

As for safety, the FDA has determined that the benefits of the booster outweigh the potential risks of myocarditis and pericarditis in this patient population. This determination was based on additional real-world data. Pfizer is also conducting post-authorization studies to assess these risks.

“The Pfizer-BioNTech COVID-19 vaccine has been available to individuals 16 years of age and older for nearly a year, and its benefits have been shown to clearly outweigh potential risks,” added Marks.

Updated fact sheets are available here.

Reference

US Food and Drug Administration. FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16- and 17-year-olds. Accessed December 9, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-pfizer-biontech-covid-19-booster-dose-16-and-17.