Shingles (Herpes Zoster) Vaccine Approved for Immunocompromised Adults

London-based GlaxoSmithKline plc (GSK) announced today the U.S. FDA had approved the Shingrix vaccine to prevent shingles (herpes zoster) for people 18+ years who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy.

Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals, says GSK.

Shingrix is the first shingles (herpes zoster) vaccine indicated for use in those who are at increased risk of the disease due to being immunodeficient or immunosuppressed due to disease or therapy. It combines a non-live antigen to trigger a targeted immune response with a specifically designed adjuvant system to generate a Varicella-Zoster Virus-specific immune response.

Shingrix is intended to be administered in two doses, 2 to 6 months apart, for immunocompetent adults.

This FDA approval for a new population was based on clinical studies examining the safety and efficacy of Shingrix in adults who had undergone an autologous hematopoietic stem cell transplant and those undergoing treatment for hematological malignancies. In addition, further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.

Thomas Breuer, Chief Medical Officer, GSK Vaccines, commented in a related press release, “Older age and being immunocompromised are the most common risk factors for shingles disease. GSK is committed to this important patient population at increased risk for shingles disease and its complications by bringing them a vaccine option that can help prevent this painful condition.”

Shingles (Herpes Zoster) is caused by the varicella-zoster virus (VZV) reactivation, the same virus that causes chickenpox. Nearly all older adults have the VZV dormant in their nervous system, waiting to reactivate with advancing age. However, as people age, the cells in the immune system lose the ability to maintain a strong and effective response to VZV reactivation, says the U.S. CDC.

More than 99% of those over 50 years old are infected with VZV, and the risk increases to 50% for adults aged 85 years and older.

Shingrix is a non-live, recombinant subunit vaccine approved in various countries. It combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a VZV-specific immune response that can help overcome the decline in immunity as people age.

However, Shingrix is contraindicated in anyone with a history of a severe allergic reaction to any vaccine component or after a previous dose of Shingrix.

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