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Review
. 2017 Dec 19;35(52):7231-7239.
doi: 10.1016/j.vaccine.2017.11.013. Epub 2017 Nov 22.

Herpes zoster vaccine live: A 10 year review of post-marketing safety experience

English D Willis  1 , Meredith Woodward  2 , Elizabeth Brown  2 , Zoran Popmihajlov  2 , Patricia Saddier  2 , Paula W Annunziato  2 , Neal A Halsey  3 , Anne A Gershon  4
Affiliations
Review

Herpes zoster vaccine live: A 10 year review of post-marketing safety experience

English D Willis et al. Vaccine. .

Abstract

Background: Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed.

Methods: All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed.

Results: A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (<1%) with 38% occurring in immunocompromised individuals. All reports of disseminated HZ confirmed by PCR as VZV Oka/Merck vaccine-strain were in individuals with immunosuppressive conditions and/or therapy at the time of vaccination.

Conclusions: The safety profile of ZVL, following 10 years of post-marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies.

Keywords: Herpes zoster; Post-marketing; Safety; Shingles vaccine live; Zoster vaccine live.

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Conflict of interest statement

Potential conflicts of interest

EW, MW, EB, ZP, PS, PA are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and may own stock or stock options in the company. NH reports having served on a safety monitoring committee for one of the post-licensure safety studies included in this manuscript and currently serving on a post-licensure safety monitoring committee for HPV vaccine produced by Merck. AG reports research grants from NIH R01 and from DSMB for GSK Subunit zoster vaccine outside the submitted work.

Figures

Fig. 1
Fig. 1
Confirmed herpes zoster cases from clinical trials in the first 6 weeks following vaccination (SPS and ZEST combined)a.
Fig. 2
Fig. 2
Post-marketing adverse experiences of herpes zoster reported weeks 1 through 6 postvaccination with ZVL (N = 1717).
See this image and copyright information in PMC

References

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