End-of-trial data show 79.7% efficacy in participants aged 50 years and over, six to 11 years after vaccination [i]
Vaccine efficacy remains high at 82.0% at year 11 after initial vaccination i
No new safety concerns were identified during the follow-up period i
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
79.7% 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)
82.0% VE in adults ≥50 at year 11 (95% CI 63.0–92.2), showing VE remains high in each year after vaccination
73.1% 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, [ii] 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. [iii] [iv] [v] [vi] A variety of factors can increase the risk of developing shingles, including advancing age and immunodeficiency or immunosuppression, [vii] as well as other chronic conditions such as COPD, diabetes mellitus, and asthma. [viii] Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face, [ix] 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), [x] 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. [xi]
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.
