The U.S. Food and Drug Administration Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-olds
On 12 December, the U.S. Food and Drug Administration (FDA) expanded eligibility for use of a single booster dose of the Pfizer-BioNTech or Comirnaty vaccine for individuals 16 and 17 years of age at least six months after completion of a primary vaccination series with one of these vaccines.
In the time since Pfizer initially submitted safety and effectiveness data to the FDA on a single booster dose following the two-dose primary series, additional real-world data have become available on the increasing number of cases of
COVID-19, in the U.S., and on the risk of myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the outer lining of the heart) following vaccination with the Pfizer-BioNTech COVID-19 Vaccine.
These additional data enabled the FDA to reassess the benefits and risks of the use of the vaccine in a wider population. The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech or Comirnaty COVID-19 vaccine, in terms of providing protection against COVID-19 and the associated serious consequences that can occur, including hospitalization and death, outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age.