FDA Approves Shingrix for Shingles Prevention in Immunocompromised Adults

The US Food and Drug Administration (FDA) has granted approval to Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. Immunocompromised individuals face a higher risk of shingles and associated complications compared to those with a healthy immune system.

Shingrix, administered intramuscularly in two doses, was first approved by the FDA in 2017 for adults 50 years of age or older. It is not intended for the prevention of primary varicella infection (chickenpox). This new approval significantly broadens the scope of individuals who can benefit from Shingrix's protection against shingles.

The approval for this new demographic was supported by clinical studies that evaluated Shingrix's safety and efficacy in adults who had undergone an autologous hematopoietic stem cell transplant (auHSCT) and those undergoing treatment for hematological malignancies. Additional data were gathered from adults who were, or were expected to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.

Shingrix is the first shingles vaccine indicated for use in individuals at increased risk of the disease due to immunodeficiency or immunosuppression from disease or therapy. It combines a non-live antigen with a specifically designed adjuvant system to generate a Varicella Zoster Virus (VZV)-specific immune response. For adults aged 50 years and older, Shingrix is administered in two doses, 2 to 6 months apart. However, for immunocompromised adults, the second dose can be administered 1 to 2 months after the first dose.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is considering recommendations for the use of Shingrix in immunocompromised adults. Shingrix has also been approved by the European Commission (EC) for the prevention of shingles and post-herpetic neuralgia (PHN) in adults 18 years of age or older at increased risk of shingles, with marketing authorization granted on August 25, 2020.

Shingles, caused by the reactivation of the varicella zoster virus (VZV), presents as a painful, itchy rash and can lead to postherpetic neuralgia (PHN), a condition where pain persists for months or even years after the rash has healed. With an estimated 1 million cases in the United States each year, the approval of Shingrix for a broader population marks a significant step forward in shingles prevention.