FDA set to authorize Pfizer-BioNTech COVID-19 vaccine for adolescents early next week
Reuters
May 3, 2021 05:36 MYT
May 3, 2021 05:36 MYT
The approval is highly anticipated after the drugmakers said in March that the vaccine was found to be safe.
THE U.S. Food and Drug Administration is preparing to authorize Pfizer Inc and BioNTech SE's COVID-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on Monday, citing federal officials familiar with the agency's plans.
The companies earlier this month applied to the FDA for potential approval of the vaccine, which has already been cleared in the United States for people aged 16 and above.
The 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 FDA did not immediately respond to a Reuters request for comment.
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 report added.