FDA authorizes Pfizer’s COVID-19 vaccine for 12-15 year olds

The Food and Drug Administration has granted the emergency use authorization for the Pfizer-BioNTech coronavirus vaccine to be administered to adolescents ages 12-15.

Pfizer, the first vaccine producer to receive emergency authorization in the United States and the first to run clinical trials in children under 16. Because the FDA has given the green light, the Center for Disease Control and Prevention’s vaccine advisory panel will meet on Wednesday to recommend how medical professionals should administer the vaccine. Doses will likely be given out immediately after CDC director Rochelle Walensky approves of the panel’s recommendation. An analysis that included 1,005 vaccine participants in the 12-15 age group found the vaccine was 100% effective in preventing COVID-19

In a press conference Monday night, FDA acting commissioner Janet Woodcock said that the vaccine would be distributed in the same dosage to adolescents as adults. “This vaccine is just the exact same dose and regimen as what has been given out already, so all those places, those pharmacies, those vaccine centers, all those sites can simply extend down to the younger age group,” Woodcock said. “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,” she continued. “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.”

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that there would be issues for younger age groups they wanted to discuss. “As we get down to younger children, age 11 and below, different doses of the vaccine will need to be used,” Marks said. “And there are also different benefit risk considerations because we know that younger children have been susceptible to this interesting multi inflammatory syndrome with COVID-19, and we have to make sure that we’re not going to see anything untoward in the youngest children.” The emergency authorization could benefit students by making it easier for students to return to regular schooling in person by fall if they aren’t currently. Marks also called expanding the accessibility of this vaccine to this age group a “critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic.” 





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