Global Liver Institute Applauds FDA and CDC Actions to Approve Third COVID-19 Vaccine Dose for Immunocompromised Individuals

Institution Partners | Oncology Societies | <b>Global Liver Institute</b>

Global Liver Institute (GLI) CEO and President Donna R. Cryer, JD, today applauded dual actions from U.S. government health agencies.

(Washington, D.C., Friday, August 13, 2021)—Global Liver Institute (GLI) CEO and President Donna R. Cryer, JD, today applauded dual actions from U.S. government health agencies: U.S. Food and Drug Administration approval of an additional COVID-19 mRNA vaccine dose for organ transplant recipients, liver cancer survivors, and other immunocompromised or immunosuppressed individuals, followed by a unanimous vote of recommendation for an additional dose from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. A 26-year liver transplant recipient, Cryer urged FDA approval in a letter last month. FDA leadership acknowledged awareness of the concerns upon receipt.

GLI has consistently advocated for a more muscular, proactive set of solutions for transplant recipients, cancer patients, and others with compromised immune systems during the COVID-19 pandemic, urging transplant medical societies to take action, providing practical information to patients, pressing for the inclusion of immunocompromised individuals in clinical trials for COVID-19 vaccines, and more.

Cryer made the following comment on the impact of both FDA and CDC decisions for people with compromised immune systems:

“This is great news for the seven million immunocompromised Americans, many of whom had no to little protective immune response to the standard one- and two-dose vaccine regimens and so faced risks similar to those who had chosen to take no vaccination at all, or worse, since COVID-19 infection raises our risks of severe effects from infection, including hospitalization and death. These thoughtful, data-driven moves by the physicians, biostatisticians, public health professionals and regulatory scientists at FDA and the CDC ACIP committee should provide the guidance and confidence needed for these specific categories of vulnerable patients and their healthcare providers to act to protect ourselves as the COVID-19 pandemic reaches new heights in communities around the country.

“Several next steps must be taken quickly, however, to ensure that these patient populations can realize the benefits of these decisions: 1) medical societies must update their guidance, 2) transplant centers, cancer clinics, and physician practices that treat the designated categories of immunocompromised patients must communicate with and schedule their patients for both antibody testing and vaccination, 3) community pharmacies must reach out to appropriate patients with this new information and easy, convenient, local vaccination opportunities to ensure that patients with transportation, work, and childcare challenges are not excluded from this opportunity to navigate society more safely.

“GLI thanks the FDA and CDC for their work. We will continue to closely monitor and weigh in with U.S. federal agencies, state governments, and health systems, providing patient voice and perspectives on vaccine research, access, COVID-19 treatments such as monoclonal antibodies and all other matters affecting the quality of life of transplant recipients, cancer patients and all those with autoimmune and liver conditions.”

About Global Liver Institute

Global Liver Institute (GLI) was built to solve the problems that matter to liver patients, equipping advocates to improve the lives of individuals and families impacted by liver disease. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. GLI believes liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI is the only patient-created, patient-driven nonprofit organization tackling liver health and all liver disease holistically, operating globally. Follow GLI on Twitter, Facebook, Instagram, LinkedIn, and YouTube.