FDA expands EUA for Pfizer-BioNTech COVID-19 vaccine to include booster for 16- and 17-year-olds
The U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, authorizing the use of a single booster dose for adolescents 16-17 years of age.
The booster should be given at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 vaccine, the FDA said.
The Centers for Disease Control and Prevention (CDC) also recommended the booster dose for 16- and 17-year-olds after at least six months have passed since the initial two-dose series, clearing the way for teens in this age group to get the third shot, according to news reports.
On Nov. 19, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for everyone 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.
The FDA said the EUA for a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for individuals 16 and 17 years of age is based on the FDA’s previous analysis of immune response data that supported use of a booster dose in individuals 18 years of age and older.
The FDA had analyzed the immune response data from approximately 200 participants who were between 18-55 years of age and received a single booster dose approximately six months after their second dose. The antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine, when compared to the response one month after the two-dose primary series in the same study participants, demonstrated a booster response.
In reaching their decision to expand the EUA, FDA officials considered real-world data 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. The FDA said it has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age.
Pfizer is conducting post-authorization/post-marketing studies to assess known serious risks of myocarditis and pericarditis. In addition, the FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety concerns, the FDA said.
