The US Food and Drug Administration is preparing to approve Pfizer Inc and German partner BioNTech SE’s COVID-19 vaccine for adolescents between the ages of 12 and 15 early next week, the New York Times reported on Monday, citing federal officials who are acquainted with the authority’s plans.
Approval is strongly expected after drug manufacturers 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.
In response to a Reuters request for comment, the FDA said it was examining the extension of the vaccine’s condition for emergency use, but did not provide further details.
The vaccine has already been cleared in the United States for people over 16 years of age.
Pfizer declined to comment on the NYT report.
The US director of the Centers for Disease Control (CDC) Rochelle Walensky said earlier in April that the vaccine could be approved in mid-May.
If an approval for 12-15-year-olds is granted, the CDC’s vaccine advice panel will likely meet the next day to review the clinical trial data and provide recommendations for the vaccine’s use in adolescents, the report added.
A potential approval of the vaccine would increase the country’s immunization drive and help allay fears for parents concerned about protecting their children from COVID-19.
Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year-olds, with data from Moderna’s trials expected soon.
Pfizer and Moderna have also started trials with even younger children aged six months to 11 years. Both companies have said they hope to vaccinate children under the age of 11 as early as 2022.