Safety of Herpes Zoster Vaccine in the Shingles Prevention Study

Abstract

Cooperative Studies Program, Department of Veterans Affairs, Office of Research and Development; grants from Merck to the Veterans Affairs Cooperative Studies Program; and the James R. and Jesse V. Scott Fund for Shingles Research.

Background paper to the decision not to recommend a standard vaccination with the live attenuated herpes zoster vaccine for the elderly in Germany

“…7). The risk of local reactions was higher among participants aged 60-69 years (56.6%) than among subjects aged ≥70 years (39.2%; [45]). Most local reactions were minor and disappeared within 4 days [36].…”

“…A total of 5 RCTs were included to assess the safety of the live HZ vaccine [36,37,[42][43][44][45]. They vary widely with regard to their consideration of the relevant endpoints and participant numbers.…”

Cost-effectiveness of vaccination against herpes zoster

“…22 Regarding safety of the vaccine, multiple studies have shown that Zostavax® is well-tolerated and that side reactions are generally mild. 20,20,[23][24][25][26] However, as the mean follow-up time of the SPS was limited to 3.1 y, 20,21 the duration of the vaccine protection is still unknown. A short-term persistence substudy (STPS) of the SPS recently showed that vaccine efficacy persists for at least 7 y, but also Herpes zoster (HZ) is a common disease among elderly, which may develop into a severe pain syndrome labeled postherpetic neuralgia (PHN).…”

Varicella zoster virus infection

“…Rates of serious adverse events, systemic adverse events, hospitalizations and deaths in the SPS were low in vaccine recipients and comparable with those in placebo recipients 22,151,154 . During the first 42 days after vaccination, 24 cases of zoster in placebo recipients were reported and 7 cases in the vaccination group, none of which were caused by vOka 104 .…”