FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

This afternoon, the U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5-11 years old. The authorization was based on the FDA’s evaluation of data that included input from independent advisory committee experts who voted in favor of making the vaccine available to children in this age group. This is a huge step towards protecting our Tribal communities and our precious youth from COVID-19.

Immune responses of children 5-11 years old were comparable to those of individuals 16-25 years old. In addition, the vaccine was found to be 90.7% effective in children ages 5-11. The vaccine’s safety was studied in over 3,000 children ages 5-11 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 (ACIP) will meet on November 2-3 to discuss further clinical recommendations. Once ACIP recommends the vaccine, Indian Health Service (IHS) and Tribal healthcare providers can begin to vaccinate our native children.

Pfizer’s COVID-19 vaccine for youth ages 5-11 is administered as a two-dose primary series, 21 days apart, but is a lower dose (10 micrograms) than the one used for individuals 12 years of age and older (30 micrograms). The FDA has determined this Pfizer vaccine has met the criteria for emergency use authorization (EUA). Based on the evidence available, the known and potential benefits of Pfizer’s COVID-19 vaccine for children ages 5-11 far outweigh the potential risks.

Read more here.

For questions or comments, please contact Courtney Wheeler, and visit NIHB’s COVID-19 Tribal Resource Center.