The U.S. Food and Drug Administration (FDA) has authorized the Pfizer COVID-19 vaccine for teenagers 12 to 15 years of age.
The federal agency expanded an existing emergency use authorization for the Pfizer-BioNTech vaccine, after determining that the vaccine met the statutory criteria and that the benefits of the vaccine for individuals in this age range outweighed “ known and potential risks.”
Previously, the vaccine was authorized for individuals 16 years and older with vaccines administered in two doses spaced three weeks apart.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock, M.D. said in a statement. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
According to the FDA, in a study of 190 participants aged 12 to 15, the adolescents’’ immune response to the COVID-19 was as good as the immune response of 170 test participants aged 16 to 25. In a study of 1,005 vaccine recipients aged 12-15, there was a 100 percent effectiviness rate.
Moderna has also filed to have its emergency use authorization expanded to include 12-15 year olds. In a Mass Live article, University of Massachusetts Medical School Researchers reported holding trials for adolescents, and Dr. Robert Finberg stated that he expected to receive authorization soon.
Similarly, Johnson & Johnson has expanded its clinical trials to focus on adolescents aged 12 to 17. In early April, the New Jersey-based pharmaceutical company announced its plans to expand clinical trials with a randomized, double-blind, placebo-controlled study.
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