GSK reveals significant Shingrix vaccine efficacy in ZOSTER-049 trial

GSK plc announced the results of the ZOSTER-049 phase III long-term follow-up trial, showcasing that the Shingrix (Recombinant Zoster Vaccine or RZV) maintains high efficacy against shingles for more than a decade in adults aged 50 and above. The detailed findings will be presented at the forthcoming ESCMID Global 2024 event in Barcelona, Spain.

The trial, which is an extension of the earlier ZOE-50 and ZOE-70 phase III studies, reported a vaccine efficacy of 79.7% in adults aged 50 and older over a period spanning six to eleven years post-vaccination. Impressively, efficacy rates peaked at 82.0% at the eleven-year mark, illustrating sustained protection with each passing year. For participants over 70, the efficacy stood at 73.1% during the same period, reinforcing the vaccine’s performance across different age groups.

Dr. Javier Díez-Domingo, the principal investigator from FISABIO, highlighted, “These final data demonstrate continued protection over more than a decade with high efficacy maintained in both the 50+ and 70+ age groups. Infectious diseases like shingles pose a significant risk to adults due to the natural decline in our immune system, and these data represent a remarkable advancement in our understanding of long-term protection against shingles.”

Phil Dormitzer, Senior Vice President and Head of Vaccines R&D at GSK, added, “With the vaccine now included in many national immunisation programmes, these data add to the evidence of extended long-term protection against shingles and provide further confidence to inform public immunisation strategies.”

Shingles, which will affect up to one in three individuals in their lifetime, presents as a painful rash and is significantly linked with age and immune system decline. Following the rash, up to 30% of affected individuals suffer from post-herpetic neuralgia, a debilitating nerve pain that can persist for years. The disease causes substantial healthcare and economic burdens, with a significant portion of patients reporting extended work absences.

GSK plc continues to evaluate long-term data and conduct studies to understand vaccine efficacy, immunogenicity, and safety across various populations. These ongoing studies aim to assess the potential need for revaccination among high-risk groups.

Shingrix is a non-live, recombinant subunit vaccine aimed at preventing shingles in individuals aged 50 and above. It combines an antigen with an adjuvant system to enhance the immune response in older adults, which is crucial given the natural, age-related decline in immunity.