NBC NEWS - Pfizer and BioNTech announced Thursday that they had submitted an emergency request to the U.S. Food and Drug Administration for authorization of the companies' two-dose Covid-19 vaccine in children ages 5 to 11.
"With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19," Pfizer tweeted. "We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat."
An FDA advisory committee plans to meet to discuss authorization on Oct. 26.
The companies said last month that the vaccine was safe in children 5 to 11 and showed a “robust” antibody response based on data collected in a trial that included more than 2,000 children.
During the trial, children were given two smaller doses than those given to people who are 12 and older. Pfizer and BioNTech said the shots produced antibody responses and side effects that were comparable to those seen in a similar study of people 16 to 25 who received the full dose of the vaccine.
Pfizer first applied for emergency use authorization for its vaccine for adults in November. The FDA in August granted full approval to the vaccine for people ages 16 and older, becoming the first vaccine against the coronavirus to pass this final regulatory hurdle.
The vaccine is currently given to 12- to 15-year-olds under the FDA's emergency use authorization.
According to data by the Centers for Disease Control and Prevention, more than 186 million Americans have been fully vaccinated.
Pfizer's shots are one of three that are being used in the U.S, along with Moderna's two-dose vaccine and Johnson & Johnson's single-shot vaccine. Moderna and Johnson & Johnson are still in the research phase of the shots being used for children 5 to 11.