Pfizer (PFE) - Get Pfizer Inc. Report and BioNTech (BNTX) - Get BioNTech SE Report have requested authorization for their COVID-19 vaccination to be used in the European Union in children ages 12 to 15, media reports say.
If the vaccine is authorized for the age group, these children take one step closer to being back in school in the fall.
The pharmaceutical companies also plan to ask other drug regulators worldwide for clearance to use the vaccine for children in this age range, they said in a statement.
They similarly sought authorization with the U.S. Food and Drug Administration in early April, after trials determined that the vaccine was 100% safe for adolescents aged 12 to 15.
The submissions are based on positive data from a late-stage clinical trial that enrolled 2,260 participants aged 12 to 15, the companies said.
The trials “demonstrated 100% efficacy and robust antibody response after vaccination with the COVID-19 vaccine,” the companies added.
The vaccine may be authorized for 12- to 15-year-olds by mid-May, Rochelle Walensky, director of the U.S. Centers for Disease Control and Prevention, told ABC News earlier this month.
The Pfizer-BioNTech shots are already authorized for children as young as 16 in the EU as well as in the U.S.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Pfizer Chief Executive Albert Bourla said in late March.
At last check Pfizer shares were trading 0.2% lower at $38.54. BioNTech shares were trading 2.3% higher at $183.69.