Pfizer COVID-19 Vaccine Fully Approved by FDA for Ages 16 and Older

On Monday, August 23, 2021, the Pfizer-BioNTech vaccine, now known as Comirnaty, is the first COVID-19 vaccine to receive full approval from the Food and Drug Administration (FDA), replacing its emergency use authorization (EUA) for all Americans over the age of 16 years including American Indians and Alaska Natives (AI/ANs). The Pfizer (Comirnaty) vaccine continues to be available under EUA for Native youth ages 12-15 years and certain immunocompromised persons who are receiving a third dose.
Pfizer’s formal approval marks an important milestone in the fight against COVID-19 for our Tribal communities. As stated by Acting FDA Commissioner, Dr. Janet Woodcock, “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” According to vaccination data from the Centers for Disease Control and Prevention (CDC), over 170 million people in the United States are fully vaccinated. Of those 170 million people, over 92 million have received the Pfizer (Comirnaty) COVID-19 vaccine. Based on available race/ethnicity data, just over one million AI/ANs are fully vaccinated. Indian Country has done a remarkable job vaccinating Tribal citizens. For example, the Sac and Fox Tribe of the Mississippi had 70 percent of its vaccine eligible citizens fully vaccinated as early as May 2021! Full FDA approval provides confidence in the safety and efficacy of the Pfizer (Comirnaty) vaccine and will encourage hesitant American Indian and Alaska Native people to get vaccinated.h
All three vaccines, Pfizer (Comirnaty), Moderna, and Johnson & Johnson are available for use in Indian Health Service (IHS) facilities and Tribal health systems. As the more contagious Delta variant spreads, the announcement of the full FDA approval is another step forward as IHS, Tribal healthcare providers, and Tribal public health professionals continue to protect elders, children, and those who cannot be vaccinated against COVID-19.
For vaccine resources, check out National Indian Health Board’s (NIHB) “Questions to Ask Your Provider”, for patients to use when considering getting a COVID-19 vaccine.
For questions or comments, please contact Courtney Wheeler, and visit NIHB’s COVID-19 Tribal Resource Center.