ASN Applauds Efforts to Authorize Third Vaccine Dose
ASN applauds the U.S. Food and Drug Administration for amending the emergency use authorizations for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, including kidney transplant recipients.
ASN applauds the U.S. Food and Drug Administration for amending the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically solid organ transplant recipients or those who are diagnosed with conditions considered to have an equivalent level of immunocompromise on August 12, 2021. Furthermore, ASN praises the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices approval of updated guidance for implementing the amended EUA on August 13, 2021. ASN has advocated for this important move.
Given that current research suggests that kidney transplant recipients may not receive protection after two doses of the COVID-19 vaccine, ASN supports implementation of a plan that would dispense a third dose to kidney transplant recipients and others who have immune systems that are similarly compromised.
Over 45% of transplant patients have not had any antibody response to the vaccine after two doses, and, of those who developed antibodies, their levels were generally lower than those with non-compromised immune systems, according to a new study.
In a recent letter, Representative Jaime Herrera Beutler called on the US Department of Health and Human Services (HHS) Secretary Xavier Becerra “to work to expedite the provision of a third dose for immunocompromised and immunosuppressed individuals without sacrificing safety.”
“Additionally, I ask HHS to move swiftly to provide options for this population, as research has shown that immunocompromised individuals can have prolonged infections, which provide conditions for variants to emerge,” wrote Beutler. “Finally, I urge HHS to prioritize research to rigorously study the impact of COVID-19 on organ transplant recipients and the larger immunocompromised community, including which vaccination methods are best for this population (mRNA, vector vaccines, and protein subunit vaccines), as well as the combination of multiple types of vaccines. This is of increased importance for solid organ transplant recipients who in many cases have been excluded from vaccine clinical trials.”
On behalf of Americans living with a solid organ transplant or health conditions leading to a compromised immune system, ASN supports this call to action. The society also continues to support quality pre-transplant, transplant, and post-transplant care. The expansion of immunosuppressive drug coverage for kidney transplant patients, a longstanding ASN policy priority, has been enacted into law after decades of advocacy.
In December 2020, the US Senate passed the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act as part of a broad year-end legislative package, extending Medicare coverage of life saving immunosuppressive medications for the life of the kidney transplant. The law is expected to save Medicare $400,000,000 over 10 years by averting the return of transplant patients to dialysis.