The emergency use authorization is based on the agency’s previous analysis of immune response data that supported use of a dose for individuals aged 18 years and older.
The FDA has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include the use of a single booster dose for individuals aged 16 and 17 years, at least 6 months after the completion of primary vaccinations with the Pfizer vaccine.
“As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19,” Janet Woodcock, MD, acting commissioner for the FDA, said in a statement.
The new action makes the FDA-authorized Pfizer vaccine and the FDA-approved Comirnaty vaccine, both of which are mRNA vaccines, the only vaccines that are available for 16- and 17-year-olds.
This age group should only receive the Comirnaty or Pfizer booster doses, according to the FDA.
“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 center for biologics evaluation and research at the FDA, said in the statement.
“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. 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 said.
The EUA is based on the FDA’s previous analysis of immune response data that supported the use of a booster dose for individuals aged 18 years and older.
The analysis included about 200 individuals, aged 18 through 55 years, who received a booster dose about 6 months after their second doses. The antibody response against the SARS-CoV-2 virus 1 month after a booster dose of the vaccine, when compared to the response 1 month after the 2-dose primary series in the same individuals, demonstrated a booster response.
On November 19, the FDA announced the authorization of a single booster dose of the Pfizer vaccine for administration to all individuals who are aged 18 years or older after the completion of their primary vaccinations with any FDA-authorized or approved COVID-19 vaccine.
Pfizer is conducting post-authorization/post marketing studies to assess the known risks of myocarditis, inflammation of heart muscles, and pericarditis, inflammation of the outer lining of the heart, from previously submitted effectiveness and safety data on a single booster dose after the 2-dose series to the FDA.
In addition, real-world data have become available about these risks.
The FDA did not hold a meeting of the Vaccines and Related Biological Products Advisory Committee for this decision, but the agency previously convened the committee for extensive discussions regarding the use of all COVID-19 booster doses.
The FDA will be publicly posting documents regarding the agency’s decision on its website.
Coronavirus (COVID-19) update: FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16- and 17-year-olds. FDA. News release. December 9, 2021. 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