The US Food and Drug Administration (FDA) is preparing to authorize use of the Pfizer-BioNTech COVID-19 vaccine in adolescents 12 to 15 years old by early next week, federal officials familiar with the agency’s plans told The New York Times on Monday.
The authorization could come as early as late this week, according to the federal officials, who did not give their names because they weren’t authorized to speak publicly.
If it is granted, the Centers for Disease Control and Prevention’s vaccine advisory panel will likely meet the following day to review the clinical trial data and make recommendations for the vaccine’s use in adolescents.
The clearance would be a major development in the nation’s vaccination campaign and welcome news to parents anxious to protect their children during summer activities and before the start of the next school year.
Pfizer and its German partner BioNTech SE said last month they have requested the FDA to expand the emergency use of their COVID-19 vaccine in adolescents aged 12 to 15.
In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.
Pfizer has also begun testing its vaccine on younger children. The global study of 144 participants will also examine whether the vaccine can generate an immune response in children and determine the proper dosage for each age group in the trial: 6 months to 2 years; 2 years to 5 years; and 5 years to 11 years.