The U.S. Food and Drug Administration (FDA) has granted full approval of the first COVID-19 vaccine. 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.
American Association of Kidney Patients (AAKP)
AAKP, the largest independent kidney patient organization in the nation, issued a formal statement in support of today’s announcement by the FDA that the agency had granted, based on additional safety and efficacy data, full approval of the Pfizer/BioNtech vaccine for COVID-19. The Pfizer/BioNTech vaccine, and two other COVID-19 vaccines, have been available over the course of the past year under FDA’s emergency use authorization (EUA).
“The American Association of Kidney Patients (AAKP) thanks the U.S. Food and Drug Administration (FDA) for granting full authorization for the Pfizer/BioNTech vaccine and we hope FDA completes their safety and efficacy review for other COVID-19 vaccines with a sense of urgency. As our nation battles the pandemic and the highly transmissible Delta variant, unvaccinated Americans continue to be at high-risk of contracting the disease and suffering from severe complications, including Acute Kidney Injury (AKI), lengthy hospitalizations, and death. Just as importantly, unvaccinated Americans pose an extremely serious risk to their families, friends, and communities; especially to people whose unique vulnerabilities to COVID-19 infection are not visible. These people include immunosuppressed kidney transplant recipients and immunocompromised patients managing severe chronic diseases and other medical conditions.
It is our hope that every American will gain confidence from FDA’s announcement, consult with their doctors, act responsibly, and secure their vaccinations if they have not already done so. As kidney patients, we understand what it means to involuntarily forfeit good health to disease, spend years on an organ transplant waiting list, have life expectancy shortened by the brutality of dialysis, and watch those who love us suffer. Please take advantage of the miraculous gift vaccines provide you and your family to avoid serious illness, the destruction of your dreams and aspirations, and the senseless and completely avoidable loss of yet another human life.
As Americans, we must unite and maintain our empathy for one another to defeat this pandemic and we must stand together above the cynics who seek to erode our common belief in the rights and dignity of every individual in our society.”