Although the interpretation of the safety data are subject to limitations resulting from the need to maintain participant-level study blinding, at present, no safety concerns have been raised by either the independent monitors who have critically reviewed and analyzed the unblinded safety data during the course of the study or the spon- sor’s firewall team, who reviewed and con- firmed the results presented here. Exacerbation or triggering of immune-mediated diseases in susceptible persons is a hypothetical concern for vaccines containing new adjuvants such as AS01B because of their immunostimulatory effects.16,34,35 Through careful monitoring during the course
of the study, we found no evidence that immune- mediated diseases occurred more frequently among HZ/su recipients than among placebo recipients. The safety of HZ/su will continue to be monitored in the ongoing ZOE-50 and ZOE-70 studies.
In conclusion, the HZ/su vaccine significantly reduced the risk of herpes zoster among adults who were 50 years of age or older, and overall efficacy was well preserved among participants who were 70 years of age or older.