The U.S. Food and Drug Administration has authorized the emergency use of the Pfizer coronavirus vaccine for children ages 5 to 11, the agency announced Friday.
FDA said it completed a “thorough and transparent” assessment of data prior to making its decision, including feedback from an independent advisory group that favored making the COVID-19 vaccine available to this age group.
While the authorization is a big step toward protecting children against the novel virus, the Centers for Disease Control and Prevention still must provide its own recommendation before shots become available, STAT reported.
“As a mother and a physician, I know that parents, caregivers, school staff and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” acting FDA commissioner Janet Woodcock, MD, said in a statement. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”
During testing, the FDA studied the safety of the vaccine in more than 3,100 children ages 5 to 11. As it stands, no serious side effects have been reported in the ongoing study. Additionally, researchers found this age group exhibited similar immune responses to those ages 16 to 25.
The administration is optimistic its authorization and transparency will make it easier for parents to decide to protect their children against the virus.
“We are confident in the safety, effectiveness and manufacturing data behind this authorization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, added Oct. 29. “We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated.”
Read the full FDA statement here.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.