Joseph Cacchione, MD, FACC
Executive Vice President, Clinical & Network Services, Ascension
Earlier today, the Food and Drug Administration gave full approval to the Pfizer-BioNTech COVID-19 vaccine, making it the first COVID-19 vaccine to go from emergency use authorization (EUA) to full FDA approval. The vaccine had been granted EUA in December 2020, as had the COVID-19 vaccine from Moderna.
“The vaccine has been known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” the FDA said in a news release.
In addition to the Pfizer-BioNTech and Moderna vaccines, the other vaccine available in the U.S. is from Janssen (Johnson & Johnson), which was granted EUA in February 2021.
As of last Friday, more than 200 million doses of the Pfizer-BioNTech vaccine had been administered in the United States, immunizing more than 91 million people nationwide, according to data from the Centers for Disease Control and Prevention.
This is an important milestone. While all of the COVID-19 vaccines available in the U.S. have long been considered safe and highly effective, now that the FDA has granted full FDA approval to Comirnaty (the Pfizer-BioNTech COVID-19 vaccine) we anticipate that many more people in our communities will step up to be vaccinated, helping us overcome the COVID-19 pandemic together.
As the pandemic continues and new variants of the virus have emerged, Ascension continues to focus on ensuring our associates are protected – for the safety of patients and visitors, our associates, our families and loved ones, and the community.
That’s why, like many health systems across the country, we are requiring our associates to be vaccinated against COVID-19. Ascension conducted a thorough moral and ethical analysis as part of the decision-making process. This decision is rooted in our Mission commitment to leading with quality and safety. As a healthcare provider and as a Catholic ministry, ensuring we have a culture of safety for our associates, patients and communities is foundational to our work.
Together as one integrated health ministry, we will put this pandemic behind us so that we can continue to focus on meeting the needs of those who come to us for care.