Issued:
GSK's Shingrix new prefilled syringe presentation receives positive CHMP opinion
· Prefilled syringe offers a convenient ready-to-use administration option to healthcare professionals
· Marketing authorisation in EU expected in
· Shingles affects approximately 1.7 million people in
GSK's shingles vaccine has been approved in the
About shingles
Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox.[5] Globally, up to 1 in 3 adults will develop shingles in their lifetime.5,[6],[7],[8] Over 90% of adults have the varicella-zoster virus (VZV) dormant in their nervous system, waiting to reactivate.6,[9],[10],[11] 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.5,[12]
Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face.9 Following the rash, up to 30% of people experience PHN,[13] a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years.5 Shingles is also associated with significant healthcare and human cost, with one in three patients with shingles taking an average of 12.5 days of sick leave and patients with PHN taking sick leave for an average of two months.[14]
About Shingrix (Recombinant Zoster Vaccine or RZV)
Shingrix combines an antigen, glycoprotein E, with an adjuvant system, AS01B, and may help overcome the natural age-related decline in responses to immunisation that contributes to the challenge of protecting adults aged 50 and over from shingles.2,3 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.
Please refer to the Product Information (PI) for important dosage, administration, and safety information in
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.com.
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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 2024, and GSK's Q2 Results for 2025.
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References
[1] Pinchinat et al. Similar herpes zoster incidence across
[2] Cunningham, AL, et al. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older.
[3] The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from
[4] GSK. Data on file 2025.
[5] Harpaz R, et al.
[6]
[7] Lee C, et al. Lifetime risk of herpes zoster in the population of
[8] Curran D, et al. Meta-Regression of Herpes Zoster Incidence Worldwide. Infect Dis Ther. 2022;11(1):389-403.
[9] Mueller, N.H., et al. Varicella zoster virus infection: clinical features, molecular pathogenesis of disease, and latency. Neurologic clinics. 2008;26(3):675-97.
[10] Johnson, R.W., et al. Herpes zoster epidemiology, management, and disease and economic burden in
[11] Bricout, H., et al. Herpes zoster-associated mortality in
[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] Kawai, K., et al. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ open. 2014;4(6).
[14] Ultsch B, Koster I, Reinhold T, et al. Epidemiology and cost of herpes zoster and postherpetic neuralgia in
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