This past Monday, the U.S. Food and Drug Administration (FDA) finally issued its approval for the Pfizer-BioNTech COVID-19 vaccine for use on adolescents between the ages of 12 and 15.
The FDA stated in a release that the efficacy rate of the vaccine on people of that particular age group, going on to say that an “analysis of cases of COVID-19 occurring among participants, 12 through 15 years of age, seven days after the second dose was also conducted. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, no cases of COVID-19 occurred among 1,005 vaccine recipients and 16 cases of COVID-19 occurred among 978 placebo recipients; the vaccine was 100% effective in preventing COVID-19.”
The release announcement stated, “The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine.”
The government agency stated that the possible side effects seen in participants in the clinical trial consisted of “pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain,” adding that said side effects were reported more often after the second dose, however, side effects could be seen after either dose.
“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,” stated Janet Woodcock, M.D, Acting FDA Commissioner. “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.”
The FDA went on to add that there isn’t enough data to determine whether the vaccine can prevent transmission of the virus or determine the amount of time that the vaccine provides protection from COVID-19.
The FDA also stated that the Pfizer-BioNTech COVID-19 vaccine “should not be given to anyone with a known history of a severe allergic reaction, including anaphylaxis—to any component of the vaccine. Since its authorization for emergency use, rare severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine in some recipients.”
“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” stated Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”
Back in December, the FDA issued an emergency authorization (EUA) to the Pfizer COVID-19 vaccine for use on individuals 16 and older. The vaccine is part of a two-dose regimen, to be spaced roughly three weeks apart, and has shown a roughly 95% effective rate at preventing infection from COVID-19. It was the first of the vaccines to receive such authorizations.