Data at the end of a long-term study shows Shingrix continues to provide high protection against shingles in adults aged 50 and over for more than a decade
GSK plc (LSE/NYSE: GSK) has announced positive data from the ZOSTER-049 long-term follow-up phase III trial which followed participants for up to approximately 11 years following initial vaccination with Shingrix (Recombinant Zoster Vaccine or RZV). The final trial data demonstrate that Shingrix maintains efficacy against shingles for more than a decade in adults over 50. The data was presented at ESCMID Global (European Society of Clinical Microbiology and Infectious Diseases) 2024, formerly known as ECCMID in Barcelona, Spain (27–30 April 2024). i The results from ZOSTER-049, an extension from two phase III clinical trials in adults aged 50 and over (ZOE-50 and ZOE-70), include: i
- 7% vaccine efficacy (VE) in adults aged ≥50 cumulatively within the period from year six to year 11 after vaccination (95% CI 73.7–84.6)
- 0% VE in adults ≥50 at year 11 (95% CI 63.0–92.2), showing VE remains high in each year after vaccination
- 1% VE in adults aged ≥70 cumulatively from six to 11 years after vaccination (95% CI 62.9–80.9) showing high VE rates across all age groups
Dr Rashmi Hegde, Executive Vice President – Medical Affairs, GSK India, said, “These findings, demonstrating efficacy and protection against shingles over an extensive 11-year period, provide reassurance for both doctors and patients. Given that ageing adults are at a higher risk of complications from shingles, [i] we hope that these findings instil confidence in policymakers to include shingles vaccination in public immunisation plans for adults.”
Globally, shingles will affect up to 1 in 3 people in their lifetimes. [ii] [iii] [iv] [v] A variety of factors can increase the risk of developing shingles, including advancing age and immunodeficiency or immunosuppression, [vi] as well as other chronic conditions such as COPD, diabetes mellitus, and asthma. [vii] Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face, [viii] with the pain often described as aching, burning, stabbing or shock-like. iii Following the rash, up to 30% of people experience post-herpetic neuralgia (PHN), [ix] a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years. iii Shingles is also associated with significant healthcare and human cost, with 57% of people with shingles reported missing work for an average of 9.1 days. [x]
We will continue to evaluate long-term data and conduct real-world evidence studies related to vaccine efficacy, immunogenicity, and safety across indicated populations, including those at highest risk of shingles to assess a potential need for revaccination in future.
[i] Presentation and management of herpes zoster (shingles) in the geriatric population
[ii] 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.
[iii] Australian Institute of Health and Welfare. Shingles in Australia. Available at: https://www.aihw.gov.au/getmedia/759199ff-f5c8-421d-a572-aaa984a02b49/aihw-phe-236_shingles.pdf.aspx Last Accessed: May 2024.
[iv] Lee C, et al. Lifetime risk of herpes zoster in the population of Beijing, China. Public Health Pract (Oxf). 2023; 5:100356.
[v] Curran D, et al. Meta-Regression of Herpes Zoster Incidence Worldwide. Infect Dis Ther. 2022;11(1):389-403.
[vi] Chen S-Y, et al. Incidence of herpes zoster in patients with altered immune function. Infection. 2014; 42: 325–334.
[vii] Marra F, et al. Risk Factors for Herpes Zoster Infection: A Meta-Analysis. Open Forum Infect Dis 2020;7(1): ofaa005.
[viii] Mueller, N.H., et al. Varicella zoster virus infection: clinical features, molecular pathogenesis of disease, and latency. Neurologic clinics. 2008;26(3):675-97.
[ix] Kawai, K., et al. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ open. 2014;4(6).
[x] Rampakakis E, Stutz M, Kawai K, Tsai TF, Cheong HJ, Dhitavat J, et al. Association between work time loss and quality of life in patients with Herpes Zoster: a pooled analysis of the MASTER studies. Health and Quality of Life Outcomes. 2017;15(1).
