SHINGRIX approved in Canada for adults at increased risk of shingles due to immunodeficiency or immunosuppression
Mississauga, ON – 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).[1][2] 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 [3],[4],[5],[6]
About Shingles
Shingles is caused by varicella zoster virus (VZV), the same virus that causes chickenpox.[7] Shingles typically presents as a rash, with painful blisters across the chest, abdomen, or face. The pain is often described as aching, burning, stabbing or shock-like. Following the rash, a person can also experience post-herpetic neuralgia (PHN), pain that can last for months or years.[8] PHN is the most common complication of shingles, occurring in up to 30 percent of all shingles cases.[7]
Shingles affects an estimated 130,000 Canadians annually.[9] Incidence rates are similar throughout North America, Europe and Asia-Pacific regions.[10] Older adults and those with conditions that compromise the immune system have the greatest risk for developing shingles. Nearly all adult Canadians (>90%) have had chickenpox and are therefore at risk for shingles. An estimated 30% will develop shingles in their lifetime and the risk increases to 50% for those who live to 85 years of age.[11][8]
About SHINGRIX
SHINGRIX [Herpes Zoster vaccine (non-live recombinant, AS01B adjuvanted)] is a non-live, recombinant subunit adjuvanted vaccine to help prevent herpes zoster (shingles). In adults 50 years of age and older, the vaccine is to be given intramuscularly in two doses with a two-to-six month interval between doses and combines an antigen (VZV glycoprotein E) and an adjuvant system (AS01B).[8] For adults 18 years of age and older who are or will be immunodeficient or immunosuppressed due to known disease or therapy and who would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first dose. The Canadian Prescribing Information for SHINGRIX (Product Monograph), posted at www.ca.gsk.com, should be consulted for complete administration and safety information.
SHINGRIX is currently publicly funded for eligible Canadians through the Ontario shingles immunization program, Yukon shingles immunization program, Veteran Affairs Canada Plan, First Nations Health Authority Plan and Non-Insured Health Benefits Program.
About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information, please visit www.ca.gsk.com
References
[1] Bastidas A, et al. JAMA 2019;132:123–133.
[2] Dagnew AF, et al. Lancet Infect Dis 2019;19:988–1000
[3] Berkowitz EM, et al. J Infect Dis 2015;211:1279–1287
[4] Vink P, et al. Cancer 2019;125:1301–1312
[5] Vink P, et al. Clin Infect Dis 2019. doi: 10.1093/cid/ciz177
[6] Stadtmauer E, et al. Blood. 2014;124(19):2921-2929
[7] Harpaz, et al. MMWR Recomm Rep. 2008; 57(5): 1-30. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices
[8] The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.
[9] Comite sur l’immunisation du Quebec (CIQ). Avis sur la pertinence d’ajouter la vaccination contre le zona au Programme quebecois d’immunisation, accessed April 19, 2018. https://www.inspq.qc.ca/sites/default/files/publications/2381_pertinence_vaccination_zona_programme_quebecois_immunisation.pdf (PDF - 755 KB)
[10] Brisson, M, et al. Modelling the impact of immunization on the epidemiology of varicella zoster virus. Epidemiol. Infect. 2000; 125, 651-669
[11] Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008 Jun;57(RR-5):1-30
