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:

• The primary endpoint focused on cumulative vaccine efficacy (VE) in the period from year six to year 11 after vaccination, with 79.7 per cent VE observed in adults aged ≥50 (95 per cent CI 73.7–84.6);
• VE in adults ≥50 remained high within each individual year after initial vaccination in ZOE-50 and ZOE-70, with VE in the eleventh and final year at 82 per cent (95 per cent CI 63.0–92.2); and
• High VE rates were observed across all age groups over 50 years of age, including the ≥70 group which had a cumulative VE of 73.1 per cent from six to 11 years after vaccination (95 per cent CI 62.9–80.9)

Globally, shingles will affect up to one in three people in their lifetime. As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles. A variety of factors can increase the risk of developing shingles, including advancing age and immunodeficiency or immunosuppression, as well as other chronic conditions such as COPD, diabetes, and asthma. The risk of shingles complications, such as post-herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years, also increases with age.

ZOSTER-049 is a phase III open-label, long-term follow-up trial from two pivotal phase III randomised clinical trials (ZOE-50, ZOE-70). The trial evaluated the efficacy, safety, and immunogenicity in adults 50 years and over at time of vaccination, for six additional years after completion of the ZOE-50 and ZOE-70 trials, up to approximately 11 years of follow-up.

ZOSTER-049 included over 7,000 participants from 18 countries across five continents, with vaccine recipients compared to historical controls.

No new safety concerns were identified during the follow-up period in ZOSTER-049. No serious adverse events were considered causally related to RZV vaccination by the investigators. In adults aged 50 years and over, the most frequently reported adverse reactions with RZV are pain at the injection site, myalgia, fatigue and headache. Most of these reactions were mild to moderate in intensity and generally lasted less than three days.