Referencing waning immunity of the 2-dose mRNA series and availability of the vaccine to youth in this age group for more than a year, FDA determined that benefits outweigh risks.
The FDA on Thursday announced it has amended the Pfizer-BioNTech COVID-19 vaccine emergency use authorization (EUA) to expand eligibility of a single booster dose to adolescents aged 16 or 17 years at least 6 months after completion of their primary vaccine series.
“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research in an FDA press release. “Since we first authorized the vaccine, new evidence indicates that the 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.”
“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,” Marks added.
Leading up to the EUA amendment, the FDA had analyzed immune response data from 200 adults, aged 18 to 55 years, who received a single booster dose of the Pfizer-BioNTech vaccine approximately 6 months after completing the original 2-dose series and confirmed a “booster response” compared to the response seen 1 month following the primary series. The agency, therefore, has concluded that these data “support extending the eligible booster age population to 16- and 17-year-olds.”
Pfizer-BioNTech previously announced data from a phase 3 randomized trial of a booster dose administered to more than 10 000 individuals aged ≥16 years 6 months after completion of the original series that showed a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster.
The FDA also noted that the benefits of a single booster dose outweighed any risk of myocarditis or pericarditis in this age group.
Pfizer continues to conduct postauthorization/postmarketing studies to assess the “known serious risks” of both myocarditis and pericarditis.
“As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures we have been taking during the pandemic,” said Acting FDA Commissioner Janet Woodcock, MD. “With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”