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Herpes zoster vaccine live: A 10 year review of post-marketing safety experience.
- Source :
-
Vaccine [Vaccine] 2017 Dec 19; Vol. 35 (52), pp. 7231-7239. Date of Electronic Publication: 2017 Nov 22. - Publication Year :
- 2017
-
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.<br />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.<br />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.<br />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.<br /> (Copyright © 2017 Elsevier Ltd. All rights reserved.)
- Subjects :
- Aged
Antibodies, Viral immunology
Clinical Trials as Topic
Databases, Factual statistics & numerical data
Eye virology
Female
Herpes Zoster Vaccine administration & dosage
Herpesvirus 3, Human genetics
Herpesvirus 3, Human immunology
Herpesvirus 3, Human isolation & purification
Humans
Immunocompromised Host
Male
Middle Aged
Polymerase Chain Reaction
Vaccination
Vaccines, Attenuated administration & dosage
Vaccines, Attenuated immunology
Drug-Related Side Effects and Adverse Reactions
Herpes Zoster prevention & control
Herpes Zoster Vaccine adverse effects
Product Surveillance, Postmarketing
Vaccines, Attenuated adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1873-2518
- Volume :
- 35
- Issue :
- 52
- Database :
- MEDLINE
- Journal :
- Vaccine
- Publication Type :
- Academic Journal
- Accession number :
- 29174682
- Full Text :
- https://doi.org/10.1016/j.vaccine.2017.11.013