Today, the U.S. Food and Drug Administration (FDA) fully licensed Pfizer-BioNTech’s COVID-19 vaccine – now named “Comirnaty” – for those 16 years of age and older. The agency first authorized the vaccine for emergency use in this age group in December after clinical trials showed it was safe and effective for at least two months. Now that researchers have the safety and efficacy data of approximately 44,000 people from the clinical trials, the FDA has confirmed that the benefits of the vaccine greatly outweigh the risks. The mRNA vaccine has cleared the benchmarks for licensure the FDA set last year — making it the first vaccine against COVID-19 to become fully approved in the U.S. As with all vaccines authorized and approved for use in the U.S., the vaccine monitoring system will continue to carefully monitor the safety of this COVID-19 vaccine. The interim Vaccine Information Statement (VIS) is now available for the Pfizer COVID vaccine.