Photo Credit:

SHINGRIX approved in Canada for adults at increased risk of shingles due to immunodeficiency or immunosuppression


Tuesday, 30 November 2021 10:19.AM

GlaxoSmithKline Inc. today announced that SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) has been approved in Canada for the prevention of shingles (herpes zoster) in adults aged 18 years and older 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. This indication expansion marks an important step towards increasing access to a shingles vaccine for Canadians with diverse risk factors that put them at increased risk of shingles.

"Older age and being immunocompromised are the most common risk factors for shingles disease," said Marni Freeman, Country Medical Director, GSK. "GSK is proud to offer SHINGRIX for the prevention of shingles to this important patient population at increased risk for shingles and its complications by bringing them a vaccine option that can help prevent this painful condition."

SHINGRIX, a non-live, recombinant subunit adjuvanted vaccine, given intramuscularly in two doses, was initially approved in Canada in 2017 for the prevention of shingles in adults 50 years of age or older. SHINGRIX is the first shingles vaccine indicated for use in those who are or who will be at increased risk of the disease due to being immunodeficient or immunosuppressed due to known disease or therapy. It combines a non-live antigen (glycoprotein E) and an adjuvant system (AS01B) to generate a Varicella Zoster Virus (VZV)-specific immune response. SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox). This indication expansion allows a greater number of Canadians to be eligible for SHINGRIX vaccination.

The GSK Clinical Development Program evaluated the benefit-risk profile of SHINGRIX in heterogeneous immunocompromised patient populations. This approval for the new populations was based on clinical studies examining the safety and efficacy of SHINGRIX in adults 18 years of age and older who had undergone an autologous hematopoietic stem cell transplant (auHSCT) and those undergoing treatment for hematological malignancies (post-hoc analysis). Further safety and immunogenicity data were generated in adults 18 years of age and older 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