Coronavirus: Pfizer, BioNTech ask FDA to authorize COVID-19 vaccine use in children aged 5-11

Pfizer and BioNTech on Thursday asked federal regulators for emergency use authorization to allow children between the ages of five and 11 to get their jointly-developed COVID-19 vaccine.

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Officials with Pfizer announced in a tweet that the companies had formally filed an application with the Food and Drug Administration. If the request is granted, shots could begin getting administered within weeks, The Associated Press reported. An influential FDA advisory committee is scheduled to debate whether to grant the request on Oct. 26.

If authorized, the vaccine could help protect more than 28 million people nationwide against COVID-19, according to The New York Times.

>> Related: Pfizer, BioNTech submit vaccine trial data for children ages 5 to 11 to FDA

Pfizer and BioNTech submitted data last month to the FDA after studying the effects of using a third of the vaccine dose meant for adults in about 2,300 trial participants between the ages of five and 11. The companies said that with the smaller dose, elementary-age children developed antibody levels comparable to those developed in 16- to 25-year-olds who got the vaccine.

The results were released by the company and have not been peer reviewed.

>> Related: Pfizer says vaccine prompts strong antibody response in children ages 5 to 11

Children infected with COVID-19 are less likely to develop severe symptoms compared with adults. However, the highly transmissible delta variant of COVID-19 sent nearly 30,000 children to hospitals in August, according to the Times. The newspaper reported that of the about 500 Americans under the age of 18 who have died of COVID-19, roughly 125 were children between the ages of 5 and 11.

The Pfizer-BioNTech COVID-19 vaccine is fully approved for people aged 16 and older across the U.S. It is available under an emergency use authorization for children aged 12 to 16.

About 56% of the U.S. population, or 186.3 million people, has been fully vaccinated as of Wednesday morning, according to the Centers for Disease Control and Prevention. The numbers include more than 12 million people between the ages of 12 and 17 who have been fully vaccinated.

Since the start of the pandemic, officials have confirmed over 44 million COVID-19 infections and reported more than 707,000 deaths nationwide, according to numbers compiled by Johns Hopkins University.

Over 236.6 million COVID-19 cases have been reported worldwide, resulting in more than 4.8 million deaths, according to Johns Hopkins.

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