On the eve of Halloween, the U.S. Food and Drug Administration (FDA) authorized emergency use of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11 after recent studies showed it is more than 90 percent effective and safe for that age group.
The authorization, the FDA said in a comunicado, was based on a thorough and transparent evaluation of the data that included input from experts on the independent advisory committee who voted overwhelmingly in favor of making the vaccine available to children in this age group.
Immune responses in children aged 5 to 11 were comparable to those in people aged 16 to 25, and it was found to be 90.7 percent effective in preventing COVID-19 in that age group.
The safety of the vaccine was studied in approximately 3,100 children aged 5 to 11 years and no serious side effects have been detected.
The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices will meet next week to discuss clinical recommendations.