The US FDA today expanded the emergency use authorization of Pfizer-BioNTech’s COVID-19 vaccine (brand name Comirnaty) for the prevention of COVID-19 to include children 5 through 11 years of age.
The Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).
In the US, COVID-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age. According to the CDC, approximately 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization. As of Oct. 17th, 691 deaths from COVID-19 have been reported in the US in individuals less than 18 years of age, with 146 deaths in the 5 through 11 years age group.
The authorization was based on data from the companies’ Phase 2/3 clinical trial that found the vaccine generated a “strong immune response in this cohort of children one month after the second dose.”
According to an agency statement, “The FDA has determined this Pfizer vaccine has met the criteria for emergency use authorization. Based on the totality of scientific evidence available, the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine in individuals down to 5 years of age outweigh the known and potential risks.”
Key points for parents and caregivers:
- Effectiveness: Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In that study, the vaccine was 90.7% effective in preventing COVID-19 in children 5 through 11.
- Safety: The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
- The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.
“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.”