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

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 (I

SUBMITTER: Willis ED 

PROVIDER: S-EPMC5739308 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature