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Vaccine. 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.

Author information

1
Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: english_willis@merck.com.
2
Merck & Co., Inc., Kenilworth, NJ, USA.
3
Institute for Vaccine Safety, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
4
Columbia University College of Physicians and Surgeons, New York, NY, USA.

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

PMID:
29174682
PMCID:
PMC5739308
DOI:
10.1016/j.vaccine.2017.11.013
[Indexed for MEDLINE]
Free PMC Article

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