Phase III ZOSTER-049 extension study shows that Shingrix provides 10 years of protection in shingles

These results come from ZOSTER-049 (ZOE-LTFU), an extension from two phase III clinical trials ZOE-50 and ZOE-70. From those trials, vaccine efficacy was 97% in adults 50 years and above and 91% in adults 70 years and above over a follow-up period of approximately four years.

The ZOE-LTFU study, which follows participants from the ZOE-50 and ZOE-70 clinical trials for an additional six years, is ongoing and will continue to evaluate the longer-term efficacy, immunogenicity and safety of the vaccine. In the interim analysis conducted over the >4 years of long-term follow-up, representing up to 10 years since immunisation (mean: from 5.6 (+/-0.3) to 9.6 (+/-0.3) years post-vaccination), vaccine efficacy was 81.6%. From 1 month post-second dose in those initial studies up to year 10 post-vaccination (mean: 9.6 (+/-0.3) years post-vaccination), vaccine efficacy was 89.0%.

The safety profile observed in this extension study is consistent with the established safety profile of the vaccine. No new safety concerns were identified. The incidence of serious adverse events was consistent with the age of the study population. No deaths or other Safety Adverse Events (SAE) considered related to vaccination were reported. Five cases of HZ-related complications (PHN - 3 cases and HZ disseminated disease - 2 cases) were reported. The interim analysis data will be presented on 20 October 2022 at the IDWeek congress in Washington, DC, USA.