Pfizer and its German partner BioNTech asked U.S. regulators Friday to allow the emergency use of their vaccine in adolescents ages 12 to 15.
The vaccine is currently authorized for emergency use in the United States for people age 16 and older. The companies said Friday that they requested an expansion of the authorization from the U.S. Food and Drug Administration (FDA) to include the younger age group.
In March, the drugmakers said the vaccine was found to be safe and effective and had produced robust antibody responses in 12-to-15-year-olds in a clinical trial.
It is unclear how long the FDA will take to review the data from the trial, although U.S. Centers for Disease Control and Prevention Director Rochelle Walensky told ABC news on Thursday that she expects the vaccine to be authorized for 12-to-15-year-olds by mid-May.
Also unclear is whether the FDA will require that the independent advisory board that recommended the original authorization meet in order for the companies to receive the nod in the younger age group.
Moderna and Johnson & Johnson are also testing their vaccines in 12-to-18-year-olds, and data from Moderna's trial could come soon.
Pfizer and Moderna have launched trials in even younger children, ages 6 months to 11 years old. Both companies have said they hope to be able to vaccinate children younger than 11 as soon as early 2022.
Inoculating children and young people is considered a critical step toward reaching herd immunity and taming the pandemic, many experts have said.
Pfizer and BioNtech said they plan to ask other regulatory authorities globally to allow the use of their vaccine in 12-to-15-year-olds in the coming days.
