714. Zoster Vaccine Live: A Review of Nearly 10 Years of Postmarketing Experience
Session: Poster Abstract Session: Vaccines
Thursday, October 27, 2016
Room: Poster Hall
  • willisen_192065-0001-ID_Week_Zoster_poster.pdf (767.8 kB)
  • Background: Zoster Vaccine Live (ZVL) is a live attenuated vaccine for the prevention of herpes zoster (HZ) in individuals age 50 years and older, approved in May 2006 and subsequently licensed in >50 countries. A review of spontaneous postmarketing (PM) adverse event (AE) reports following nearly 10 years of experience and > 31 million doses distributed, worldwide, was conducted.

    Methods: The Merck AE Reporting System database was queried to identify all PM reports from 02-May-2006 to 01-Nov-2015 received from healthcare providers with a temporal association to ZVL.

    Results: A total of 21,833 reports containing 42,578 AEs were identified. The majority of reports were from the US (85%), females (70%) and individuals ≥60 years of age (80%). Nine percent were from individuals < 50 years of age and were primarily reports of medication error or off label use. Of the reports with event outcome reported at the time of the report, 60% reported recovery. Among the 21,833 reports, Oka/Merck vaccine-strain varicella zoster virus (VZV), confirmed by PCR analysis, was reported in 12 reports. The most frequently reported AEs were injection site reactions (ISR) (n=8766; 21%) and HZ (n=3719; 9%). Median time to onset (TTO) from vaccination to AE for ISR was 2 days. Of the 1691 reports of HZ with available TTO, 1068 (63%) reported HZ within 6 weeks postvaccination, including 81% within 2 weeks, suggesting wild-type VZV as the likely cause. Ophthalmic HZ (HZO) (n=135) and disseminated HZ (DHZ) (n=18) accounted for <1% of the reported AEs. Median TTO of HZO was 79 days. Among the 135 reports of HZO, 9 reported a prior history of HZO. Review of these reports did not suggest an association between ZVL and recurrence of HZO. Among the 18 reports of DHZ, 7 were reports in immunosuppressed (IMS) individuals with vaccine-strain VZV confirmed in 3 reports. The AEs in the 9 remaining reports in which vaccine-strain VZV was identified were: HZ (n=4; 1 as IMS), ISR (n=2), varicella (n=3; 1 as IMS).

    Conclusion: DHZ following ZVL and AEs caused by vaccine-strain VZV have been reported rarely. Among the individuals with DHZ, several were immunosuppressed and contraindicated for ZVL. The postmarketing safety profile following nearly 10 years of ZVL use is favorable and consistent with clinical trial experience.

    English Willis, MD, FAAP1, Meredith Woodward, MSN, RN1, Zoran Popmihajlov, MD1, Elizabeth Brown, MS1, Patricia Saddier, MD, PhD1, Neal Halsey, MD, FIDSA2 and Anne Gershon, MD, FIDSA, FPIDS3, (1)Merck & Co., Inc., Kenilworth, NJ, (2)International Health, Johns Hopkins Bloomberg, Baltimore, MD, (3)Pediatrics, Columbia University Medical Center, New York, NY


    E. Willis, Merck: Employee , Salary

    M. Woodward, Merck: Employee , Salary

    Z. Popmihajlov, Merck: Employee , Salary

    E. Brown, Merck: Employee , Salary

    P. Saddier, Merck: Employee , Salary

    N. Halsey, Merck: Investigator , Research support

    A. Gershon, GSK: Scientific Advisor , honorarium contributed to Columbia Univ.
    Merck: Research Contractor , Laboratory support to perform VZV vaccine safety testing

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