Late last month, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for administration to all individuals 18 years of age and older.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” said Acting FDA Commissioner Janet Woodcock.
“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.”
The FDA noted that it didn’t hold a separate study for 16- and 17-year-olds. However, it did base its approval on an earlier study that analyzed the immune responses from some 200 participants aged 18 to 55.
Risks and rewards
In its new labeling of the vaccine, Pfizer added myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) to the list of potential risks. The company said those effects have “occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males.”
However, Pfizer is playing it safe and conducting post-authorization/post-marketing studies to assess the risks of those conditions. The FDA and the Centers for Disease Control and Prevention (CDC) have also put systems in place to monitor the vaccine's safety. The agencies stated that they are ready to detect and investigate any potential safety concerns quickly.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the Pfizer vaccine has proved that its rewards clearly outweigh any potential risks.
“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 six months prior will help provide continued protection against COVID-19 in this and older age groups,” Marks said.