BRIEF—Pfizer and BioNTech file for Comirnaty EAU approval for children

Pfizer and German partner BioNTech have filed with the US Food and Drug Administration emergency use authorization from for their Comirnaty COVID-19 vaccine for children ages 5 to 11.

If authorized, this would be the first COVID-19 vaccine for younger children.

The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an EUA for people aged 12 to 15.

Last month, Pfizer released details of a Phase II/III trial that showed its vaccine was safe and generated a robust antibody response in children ages 5 to 11.

The trial included 2,268 participants aged five to 11 and used a two-dose regimen of the vaccine administered 21 days apart.

This trial used a 10-microgram dose -- smaller than the 30-microgram dose that has been used for those 12 and older.

In anticipation of the request, the FDA last week scheduled a meeting

of its Vaccines and Related Biological Products Advisory Committee to discuss the vaccine in children aged five to 11 on October 26.