The U.S. Food and Drug Administration (FDA) extended the emergency use authorization (EAU) for Pfizer-BioNTech’s COVID-19 booster shots to include 16 and 17-year-olds. The agency’s decision came after evaluating the immune response data of about 200 individuals, ages 18-55.
Since Pfizer’s vaccine has been available to everyone 16 and older for almost a year, the data shows its benefits clearly outweigh the potential risk, according to Peter Marks, M.D., Ph.D., and director of the FDA’s Center for Biologics Evaluation and Research. Since the vaccine has proven its effectiveness begins to wane after its second dose, the agency determined a single COVID-19 booster dose six months later will help provide continued protection against the coronavirus for everyone at least 16 years old.
There was no meeting of the Vaccines and Related Biological Advisory Committee needed to reach the decision. The FDA explained it was unnecessary since the committee had already met and held extensive discussions about using COVID-19 booster doses. Also taken into consideration was a review of Pfizer’s EAU application.
Other factors the FDA considered were side effects seen earlier in male adolescents and young adults and the increasing number of coronavirus cases in the United States.
In addition, since Pfizer’s initial submission of the safety and effectiveness information on a single COVID-19 booster dose, more “real-world data” has become available on the risk of myocarditis and pericarditis.
Not only is Pfizer conducting both post-authorization and post-marketing studies to evaluate known serious risks of these side effects, but the FDA and Centers for Disease Care and Prevention (CDC) have several COVID-19 vaccine safety surveillance systems in place. As a result, they continually monitor the vaccine’s safety, which allows for rapid detection and investigation of potential problems.
The data from the intensive vaccine safety monitoring assures the FDA that amending the EAU for the COVID-19 booster to include those 16 and 17 years old is a sound decision.
As with other COVID-19 vaccine booster approvals, the CDC will likely follow with their recommendation.
COVID-19 vaccination, booster shots, and testing are free to everyone regardless of their insurance or immigration status.
It is not too late to be vaccinated for the yearly flu, which peaks in the winter but continues to infect people well into the spring. Moreover, it is safe to simultaneously receive the flu and COVID-19 shot or booster dose.
Being vaccinated against COVID-19 has proven to decrease the risk of severe infection and hospitalization. Experts advise that everyone five and older take either the Pfizer-BioNTech, Moderna, or J&J Jenssen vaccines for themselves and others.
Written by Cathy Milne-Ware
Sources:
FDA: Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds
CDC: Everyone Ages 18 and Older Should Get a Booster Shot
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