Amended EUA allows for shots in adolescents ages 12-15 years

The FDA expanded the emergency use authorization (EUA) for the Pfizer-BioNTech Covid-19 vaccine to include use in adolescents ages 12-15 years.

Pfizer applied for the amended EUA at the end of March on the weight of results from a phase III trial that found the shot, BNT162b2, to be 100% effective at preventing SARS-CoV-2 among kids in this age group. The original Dec. 11, 2020 EUA for the vaccine authorized its use in individuals 16 years of age and older—now, with this FDA decision, BNT162b2 is the only Covid-19 vaccine currently authorized for this age group in the U.S.

Janet Woodcock, MD, acting FDA commissioner, called the EUA expansion “a significant step in the fight against the Covid-19 pandemic,” in a prepared 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.”

Lee Savio Beers, MD, FAAP, president of the American Academy of Pediatrics, applauded the FDA’s decision in a statement emailed to news organizations, calling the expanded EUA “a critically important step in bringing life-saving vaccines to children and adolescents. Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development.”

Beers noted that, thus far, over 3.8 million children have tested positive for Covid-19 in the U.S.—and, while she acknowledged that the disease course has been less severe among pediatric patients, she added that “this is not a benign disease in children. Thousands of children have been hospitalized, and hundreds have died. We will soon have a very safe, highly effective vaccine that can prevent so much suffering. I encourage parents to talk with their pediatrician about how to get the vaccine for their adolescents as soon as they are eligible.”

The vaccine has one more hurdle to jump before shots start going into adolescent arms—the CDC’s Advisory Committee on Immunization Practices (ACIP) is holding an emergency meeting on Wednesday, May 12 to weigh in on the amended authorization and make recommendations for the vaccine’s use in this new population.

The FDA based its decision on available safety data for 2,260 vaccine trial participants ages 12-15. Of these, 1,131 participants were given two doses of the vaccine while the remaining 1,129 received two doses of saline placebo, after which both groups were followed up for at least two months. The results were comparable to those reported for patients ages 16 and older. “The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain,” the agency wrote. “With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. The side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older. It is important to note that as a general matter, while some individuals experience side effects following any vaccination, not every individual’s experience will be the same and some people may not experience side effects.”

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For the efficacy analysis, the FDA reviewed data from 190 trial participants ages 12-15 years and compared their immune response to 170 participants ages 16-25 years. “In this analysis, the immune response of adolescents was non-inferior to… the immune response of the older participants,” the agency wrote. “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 FDA reiterated that there are currently limited data to address whether the vaccine can prevent viral transmission from person to person, and there is no currently available data on how long vaccine efficacy lasts.

The agency updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers to reflect the amended authorization for BNT162b2, and Pfizer updated its current safety monitoring plans to include the newly authorized population.

Meanwhile, Pfizer is expected to file for full FDA approval for BNT162b2 by the end of the month, according to a 2021 earnings report. The company also announced plans to file for EUAs for the vaccine to be used in patients ages 2-11 later this year, with another submission for use in patients as young as six months to follow shortly thereafter.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 190

Topic ID: 79,190,730,933,190,31,926,192,561,927,151,928,925,934