The FDA on Oct. 29 authorized Pfizer's COVID-19 vaccine for kids ages 5 to 11.
The agency said clinical trials have shown the vaccine was 90.7 percent effective in the age group and that the immune response was comparable to people ages 16 to 25.
The vaccine's safety was studied in roughly 3,100 kids ages 5 to 11 and no serious side effects were detected in the clinical trial, which is ongoing. The trial includes a total of 4,700 kids in the age group and is being conducted in the U.S., Finland, Poland and Spain.
The CDC's Advisory Committee on Immunization Practices is set to meet Nov. 2 and 3 to discuss clinical recommendations for the vaccine in the age group, and the CDC director is expected to make a formal decision shortly after, meaning the vaccine could be available for kids ages 5 to 11 next week.
"As a mother and a physician, I know that parents, caregivers, school staff and children have been waiting for today's authorization," Janet Woodcock, MD, acting FDA commissioner, said in a news release. "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 vaccine for kids ages 5 to 11 is 10 micrograms versus 30 micrograms for everyone older than 12.
The FDA said that kids ages 5 to 11 make up 39 percent of COVID-19 cases in people younger than 18. About 8,300 cases in the age group have resulted in hospitalization and, as of Oct. 17, 691 kids under age 18 have died from COVID-19, with 146 of them being ages 5 to 11.
Commonly reported side effects after vaccination in kids ages 5 to 11 include a sore arm, redness and swelling, fatigue, headache, muscle and joint pain, chills, fever, swollen lymph nodes, nausea, and decreased appetite. Most of the symptoms came after the second dose and went away within two days, the FDA said.
The FDA also authorized a manufacturing change for Pfizer's vaccine Oct. 29, authorizing a new formulation that is more stable at refrigerated temperatures for longer, giving greater flexibility to vaccine providers.
Read the FDA's full news release here.