Independent advisory committee experts overwhelmingly voted in favor, the FDA said.
The U.S. Food and Drug Administration (FDA) has authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age. The vaccine was 91% effective at preventing symptomatic illness in this younger age group, according to a clinical trial.
BREAKING: The @US_FDA Vaccines and Related Biological Products Advisory Committee (#VRBPAC) voted in support of granting Emergency Use Authorization (EUA) for the Pfizer-BioNTech #COVID19 vaccine in children ages 5 to <12 years.
— Pfizer Inc. (@pfizer) October 26, 2021
Currently, the Pfizer vaccine is the only COVID-19 vaccine available in the U.S. for use in this age group.
“This is a day so many parents, eager to protect their young children from this virus, have been waiting for,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Over 6 million children in the U.S. have been diagnosed with COVID-19 since the start of this pandemic, and a high number of young people continue to be infected every week. With this FDA authorization, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control.”
This week, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a whether or not to recommend the use and rollout of the vaccine to children 5 through 11 years of age.
“Today’s emergency use authorization is supported by clinical data showing a favorable safety profile and high vaccine efficacy in children, underlining its potential to address a current public health need,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “As children 5 through 11 get reacclimated to the new school year, both in and out of the classroom, our goal is to help keep them safe and protected and get them back to normalcy.”