On Monday May 10, 2021, the FDA amended the December 11, 2020 emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in adolescents 16 or older to include adolescents 12 -15 years of age. The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.
Pfizer - BioNTech COVID-19 Vaccine EUA Expanded to 12-15 Years Old
May 18, 2021 3:19:28 PM / by Practice Support Team posted in COVID-19, Vaccines, fda