FDA Issues Emergency Use Authorization For COVID-19 Vaccine

On December 11, 2020, FDA issued the first emergency use authorization ("EUA") for a vaccine to prevent COVID-19. The vaccine, developed by Pfizer-BioNTech, is authorized for those 16 years of age and older. In granting an EUA, FDA reviewed clinical trial data from 37,586 participants, which established that the Pfizer-BioNTech COVID-19 Vaccine had an effectiveness of 95% in preventing COVID-19.

The scope of authorization of the EUA permits Pfizer to supply the vaccine directly or through authorized distributors to "emergency response stakeholders" at the direction of the US Government. According to the EUA, an "emergency response stakeholder" is a public health agency and its delegates "that have legal responsibility and authority for responding to an incident, based on political or geographical boundary lines (e.g., city county, tribal, territorial, State, or Federal) or functional (e.g., law enforcement or public health range) or sphere of authority to