GSK's Shingrix (Recombinant Zoster Vaccine) prefilled syringe presentation approved in Canada

• Prefilled syringe offers healthcare professionals a convenient administration option
• New presentation will begin rolling out across Canada in early 2027
• Approximately one in three Canadians will develop shingles in their lifetime, ¹ with increased age and certain chronic conditions linked to a higher risk of shingles ^{2 , 3}

MISSISSAUGA, ON, July 24, 2026 /CNW/ -- GSK Canada today announced the approval of Shingrix (GSK's Recombinant Zoster Vaccine or RZV) in a prefilled syringe. This new presentation removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals.

GSK’s Shingrix (Recombinant Zoster Vaccine) prefilled syringe presentation approved in Canada

Approval of the new prefilled syringe presentation is based on data confirming technical comparability between the new and existing vaccine presentations. The prefilled syringe presentation is expected to be available across Canada beginning in early 2027. Consistent with the existing indications for Shingrix, the prefilled syringe is licensed in Canada for the prevention of shingles in adults 50 years of age or older, as well as those 18 years of age or older who are or will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. ⁴

Dr. Michelle Horn, Country Medical Director, GSK Canada, said: "Shingles is a painful disease that can have serious and long-lasting complications, often imposing a greater burden on people living with common chronic diseases such as cardiovascular disease and diabetes. This new presentation of Shingrix has been designed to improve ease of administration, delivering a practical solution to help healthcare professionals provide protection against shingles."

The prefilled syringe presentation of Shingrix has also been approved in the US and Europe. This new presentation of Shingrix highlights GSK's commitment to providing solutions to help increase adult immunization rates.

About shingles

Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox. ⁵ Affecting an estimated 130,000 people in Canada each year, ^{6 , 7} most adults will have the VZV dormant in their nervous system, which may reactivate with advancing age. 8 As people age, the strength of the immune system response to infection decreases, increasing the risk of developing shingles. ^{9 , 10} In addition to advancing age, chronic conditions like cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease, asthma, and diabetes are all linked to higher risk of shingles. ^{11 , 12 , 13}

Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face. ¹⁴ The pain is often described as aching, burning, stabbing or shock-like. ¹⁵ Following the rash, a person can also experience post-herpetic neuralgia (PHN), nerve pain that can last weeks or months and can occasionally persist for several years. ¹⁶ PHN is the most common complication of shingles, occurring in up to 30% of all shingles cases. ¹⁷ More rarely, shingles can lead to bacterial skin infections, weakness, muscle paralysis, and loss of hearing or vision. ¹⁸

About Shingrix (Recombinant Zoster Vaccine or RZV)

Shingrix combines an antigen, glycoprotein E, with an adjuvant system, AS01_B, and may help overcome the natural age-related decline in responses to immunization that contributes to the challenge of protecting adults aged 50 and over from shingles, as well as those 18 years of age or older who are or will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. ^{19 , 20} RZV is not indicated to prevent primary varicella infection (chickenpox). The use of RZV should be in accordance with official recommendations and local product label.

The existing presentation of Shingrix consists of two vials, a lyophilized (powder) antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The prefilled syringe presentation provides a convenient method of administration.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.ca.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2025, and GSK's Q1 Results for 2026. 

REFERENCES

¹ Harpaz R, et al. 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;57(RR-5):1–30.

² Harpaz R, et al. 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;57(RR-5):1–30. 

³ Steinmann et al. Risk factors for herpes zoster infections: a systematic review and meta-analysis unveiling common trends and heterogeneity patterns. Infection. 2024;52(3):1009-1026. doi: 10.1007/s15010-023-02156-y. REF-224255.

⁴ Shingrix Product Monograph. https://ca.gsk.com/media/q55ntrsk/shingrix-pm-en.pdf

⁵ Harpaz R, et al. 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;57(RR-5):1-30.

⁶ Curran, D., et al. Meta-Regression of Herpes Zoster Incidence Worldwide. Infectious diseases and therapy. 2022;11(1):389-403.

⁷ Herpes zoster (shingles) vaccine: Canadian Immunization Guide - Canada.ca

⁸ Johnson, R.W., et al. Herpes zoster epidemiology, management, and disease and economic burden in Europe: a multidisciplinary perspective. Therapeutic advances in vaccines. 2015;3(4):109-20.

⁹ Harpaz, R., et al. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008;57(Rr-5):1-30

¹⁰ Mueller NH, et al. Varicella Zoster Virus Infection: Clinical Features, Molecular Pathogenesis of Disease and Latency. Neurologic Clinics. 2008;26;675-697

¹¹ Harpaz R, et al. 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;57(RR-5):1–30.

¹² Steinmann et al. Risk factors for herpes zoster infections: a systematic review and meta-analysis unveiling common trends and heterogeneity patterns. Infection. 2024;52(3):1009-1026. doi: 10.1007/s15010-023-02156-y. REF-224255.

¹³ Marra F, et al. Risk Factors for Herpes Zoster Infection: A Meta-Analysis. Open Forum Infect Dis. 2020;7:ofaa005.

¹⁴ Mueller NH, et al. Varicella Zoster Virus Infection: Clinical Features, Molecular Pathogenesis of Disease and Latency. Neurologic Clinics. 2008;26;675-697

¹⁵ Harpaz R, et al. 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;57(RR-5):1-30.

¹⁶ National Advisory Committee on Immunization. Updated NACI Recommendations on the Use of Herpes Zoster Vaccines. June 2018. Available at: https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/healthy-living/updated-recommendations-use-herpes-zoster-vaccines-eng.pdf. Accessed April 5, 2024

¹⁷ Kawai, K., et al. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ open. 2014;4(6).

¹⁸ National Advisory Committee on Immunization. Updated NACI Recommendations on the Use of Herpes Zoster Vaccines. June 2018. Available at: https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/healthy-living/updated-recommendations-use-herpes-zoster-vaccines-eng.pdf. Accessed April 5, 2024

¹⁹ Cunningham, AL, et al. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. New England Journal of Medicine. 2016;375(11):1019–32.

²⁰ 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.

SOURCE GlaxoSmithKline Inc.

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