The US Food and Drug Administration (FDA) gave the emergency use authorization to Pfizer’s COVID-19 vaccine for children ages 5-11. The decision is being made after a panel discussion of independent advisers to the FDA who voted Tuesday to recommend the vaccine for younger kids.
The dose of Pfizer’s vaccine for younger children will be one-third (10 micrograms) given to people ages 12 and up, and it comes in a two-dose series given three weeks apart. According to The New York Times, it could affect more than 28 million children.
Acting FDA Commissioner Janet Woodcock said, “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. 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 FDA also told that the vaccine is safe and effective in younger kids, no serious side effects have been detected in the 3,100 children ages 5 through 11 who received the vaccine as part of an ongoing study.
Before shots can be given to younger kids, the Centers for Disease Control and Prevention will also need to give its recommendation on the vaccine. An independent committee to the CDC is meeting next week and is expected to issue guidance on how shots roll out.
The Pfizer-BioNTech vaccine was fully approved by the FDA for people 16 and older in August, but is still under emergency use authorization for kids 12 through 15. Pfizer remains the only vaccine authorized in the US for kids as young as 12.
Children are at lower risk of severe COVID-19 illness and death compared with the adult population, but they can still experience complications. About 8,300 COVID-19 cases in children 5 through 11 years of age have led to hospitalization, according to the FDA release. As of Oct. 17, 146 deaths from COVID-19 have been reported in the US in children ages 5 through 11.