Editorial: First Full Regulatory Approval of a COVID-19 Vaccine, the BNT162b2 Pfizer-BioNTech Vaccine, and the Real-World Implications for Public Health Policy.

ABSTRACT

In the past 18 months, accelerated vaccine development to prevent or reduce the severity of coronavirus disease 2019 (COVID-19) has resulted in rapid global emergency regulatory approvals, including the US Food and Drug Administration (FDA) emergency use authorization (EUA) approvals. On August 23, 2021, the US FDA gave the first full regulatory approval for a COVID-19 vaccine and approved the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) for individuals 16 years and older. In the US, there is a continued EUA for individuals aged 12-15 years of age. Also, the EUA includes the administration of a third or booster dose in immunocompromised individuals at increased risk for severe COVID-19. This Editorial aims to present an update on the first COVID-19 vaccine to receive full regulatory approval, the Pfizer-BioNTech vaccine, and the implications for real-world public health during the global COVID-19 pandemic and increasing concerns for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern.