The U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine for adolescents between the ages of 12 and 15 on Monday.
The FDA explained the vaccine’s efficacy rate in individuals of this particular age group, stating 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 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 agency said that the side effects in participants in the adolescent clinical trial included “pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain,” adding that side effects were reported more often after the second dose, although side effects can be experienced 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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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 added that there is not enough data to see whether the vaccine can prevent transmission of the virus or determine the amount of time that the vaccine provides protection from COVID-19.
The agency also said 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,” said 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.”
NPR reported, “Pfizer says it won’t be ready to ask the FDA for new emergency use authorization expansions for kids younger than 12 until September. One such request would cover children from 2 to 5 years old; a second would apply to ages 5 to 11. A third request, aimed at protecting infants and toddlers, isn’t expected until the fourth quarter of this year.”
Some Americans have shown less interest in receiving vaccinations against the coronavirus in recent weeks. As The Daily Wire reported, “nearly 70% of those recently surveyed by The Economist/YouGov said they have either already received the vaccine or are planning to get it, 18% said they will not be taking the shots. When asked if they could be persuaded to get the vaccine, 79% said ‘no.’”
The FDA granted emergency authorization (EUA) to the Pfizer COVID-19 vaccine in December for individuals 16 years or older. The vaccine is part of a two-dose regimen, spaced three weeks apart, and has been shown to be 95% effective at preventing COVID-19. It was the first COVID-19 vaccine authorized by the FDA.