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

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

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.

Publication types

  • Review

MeSH terms

  • Aged
  • Antibodies, Viral / immunology
  • Clinical Trials as Topic
  • Databases, Factual / statistics & numerical data
  • Drug-Related Side Effects and Adverse Reactions*
  • Eye / virology
  • Female
  • Herpes Zoster / prevention & control*
  • Herpes Zoster Vaccine / administration & dosage
  • Herpes Zoster Vaccine / adverse effects*
  • Herpesvirus 3, Human / genetics
  • Herpesvirus 3, Human / immunology
  • Herpesvirus 3, Human / isolation & purification
  • Humans
  • Immunocompromised Host
  • Male
  • Middle Aged
  • Polymerase Chain Reaction
  • Product Surveillance, Postmarketing*
  • Vaccination
  • Vaccines, Attenuated / administration & dosage
  • Vaccines, Attenuated / adverse effects*
  • Vaccines, Attenuated / immunology

Substances

  • Antibodies, Viral
  • Herpes Zoster Vaccine
  • Vaccines, Attenuated