FDA authorizes Pfizer vaccine for kids 5 to 11

WASHINGTON, D.C. – On Friday, the Food and Drug Administration authorized the emergency use of the Pfizer/BioNTech COVID-19 vaccine to include children 5 through 11 years of age. The Centers for Disease Control and Prevention will meet next week to discuss further recommendations and possible approval so shots can start being administered.

According to the FDA, the immune responses of children 5 through 11 were comparable to people 16 through 25 years of age. In a study, the vaccine was 90.7% effective in preventing COVID-19 in children 5 through 11. There were no serious side effects reported in the study involving about 3,100 kids.

“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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.”

The Pfizer/BioNTech vaccine for children 5 through 11 years of age is administered in two doses three weeks apart, but it’s at a lower dose (10 micrograms) than the vaccine used for people 12 years of age and older (30 micrograms).

“The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust. We are confident in the safety, effectiveness and manufacturing data behind this authorization. As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon. We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.