The U.S. Food and Drug Administration is preparing to authorize the Pfizer / BioNTech Covid vaccine for teens ages 12 to 15 early next week, The New York Times reported on Monday, citing federal officials familiar with the plans for the ‘agency.
Approval is eagerly awaited after drugmakers said in March that the vaccine was found to be safe, effective and produced robust antibody responses in children ages 12 to 15 in a clinical trial.
In response to a request for comment from Reuters, the FDA said its review of extending the emergency use authorization for the vaccine was continuing, but did not provide further details.
The vaccine has already been licensed in the United States for people 16 years of age and older.
Pfizer declined to comment on the New York Times report.
U.S. Centers for Disease Control (CDC) director Rochelle Walensky said earlier in April that the vaccine could be approved by mid-May.
If approval for 12-15 year olds is granted, the CDC’s vaccine advisory committee will likely meet the next day to review clinical trial data and make recommendations for vaccine use in adolescents, the report said.
Approval of the vaccine would boost the country’s vaccination campaign and help allay the fears of parents concerned about protecting their children from Covid-19.
Moderna and Johnson & Johnson are also testing their vaccines in children ages 12 to 18, and data from Moderna’s trial is expected to be released soon.
Pfizer and Moderna have also started trials in even younger children, aged 6 months to 11 years. The two companies said they hoped to be able to immunize children under 11 by early 2022.