Statement from the National Kidney Foundation (NKF) on the U.S. Food and Drug Administration’s (FDA) Decision to revoke Evusheld’s Authorization regarding Emergency Use due to lack of efficacy against dominant COVID-19 variants
New York, NY (Feb. 7, 2022) – The following is a statement from Kevin Longino, Chief Executive Officer of the NKF and a kidney transplant recipient, regarding the FDA’s decision to revoke Evusheld’s Authorization for emergency use to immunocompromised kidney patients due to lack of efficacy against newer Omicron subvariants.
“While we support the FDA’s decision to revoke Evusheld’s authorization for emergency use considering its lack of efficacy on newer Omicron subvariants, it is more important than ever that kidney patients have access to vaccines and therapies that meet rigorous safety and efficacy against burgeoning subvariants. We strongly encourage the FDA and other biotechnology stakeholders to increase investments in innovative research and expedited access to therapeutics that protect kidney patients against COVID-19.
The vulnerability of ALL kidney patients remains heightened as the COVID-19 pandemic continues and places these patients at a higher risk for infection and mortality at alarming rates, particularly in-center and home dialysis patients, transplant recipients, and immunosuppressed chronic kidney disease (CKD) patients (e.g., patients with glomerular disease, auto-immune disorders, etc.) For the first time in 50 years since the enactment of the Medicare End Stage Renal Disease (ESRD) benefit, the greatest decline in the total number of patients on dialysis within a single year occurred in 2021 due to COVID-19 related deaths. Despite the implementation of national infection prevention and management guidelines, hospitalization incidence and death rates prior to hospitalization were exacerbated post COVID-19 diagnoses for both CKD and ESRD populations.2 Lastly, we would like to emphasize important considerations regarding low seroconversion and increased risk of vaccine-immunosuppressive drug interactions for select members of this patient population.3
As the FDA continues to research the next generation of prophylactic and therapeutic monoclonals and we enter an endemic phase of the COVID-19 virus, we recommend the inclusion of high-risk patients, specifically kidney patients including those on dialysis or after transplantation, into clinical trials as it is important to ensure that innovative therapies are safe and effective for this population. Furthermore, to protect immunocompromised patients from future COVID-19 variants, we urge the development of accelerated paths for approval and authorization of new monoclonals currently in the clinical trial phase.
We believe that utilization of this approach can assure safety while also making a timely and exponential impact on millions of lives. We welcome the possibility to partner with the FDA as a thought leader on future initiatives regarding this matter.”
About National Kidney Foundation
The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S. For more information about NKF, visit www.kidney.org
3 Babel N, Hugo C, Westhoff TH. Vaccination in patients with kidney failure: lessons from COVID-19. Nat Rev Nephrol 2022; 18:708–723. https://doi.org/10.1038/s41581-022-00617-5