The U.S. Food and Drug Administration (FDA) on Friday authorized emergency use of the Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age, Trend reports citing Xinhua.
For the Moderna vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had previously been authorized for use in adults 18 years of age and older.
For the Pfizer-BioNTech vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had previously been authorized for use in individuals 5 years of age and older.
The FDA said its evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.
The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.