FDA set to authorize Pfizer-BioNTech COVID-19 vaccine for adolescents early next week - NYT

Reuters |
Published: 05.04.21 , 06:30
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.