(Reuters) – The U.S. Food and Drug Administration is preparing to authorize Pfizer’s vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on Monday.
An approval is highly anticipated after the drugmakers said in March that the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.
The vaccine has already been cleared in the United States for people aged 16 and above.
If an approval for the 12-15 year olds is granted, the CDC’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 report added.
Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year olds, with data from Moderna’s trial expected to come soon.
Pfizer and Moderna have also launched trials in even younger children, aged six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.