FDA authorizes first COVID-19 vaccine for children ages 5 to 11


The U.S. Food and Drug Administration (FDA) announced on Friday the emergency use authorization of the Pfizer-BioNTech novel coronavirus (COVID-19) vaccination for children ages five to 11 years old, according to a statement by the agency.

According to the FDA, immune responses of children ages five to 11 years old were comparable to those of individuals 16 to 25 years old. In addition, the vaccine was found to be 90.7 percent effective in preventing COVID-19 in children ages 5 to 11 years old.

The vaccine’s safety was studied in approximately 3,100 children ages five to 11 years old who received the vaccine and no serious side effects have been detected in the ongoing study. The Pfizer-BioNTech vaccine for children five to 11 years of age is administered as a two-dose primary series, three weeks apart, but is a lower dose of 10 micrograms than that used for individuals 12 years of age and older of 30 micrograms.

The FDA previously authorized the Pfizer-BioNTech vaccine in children ages 12 to 15 years old. The new emergency use authorization expands on the existing guidance.

The U.S. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.