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

ABSTRACT: 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.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.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.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.

SUBMITTER: Willis ED

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

REPOSITORIES: biostudies-literature

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

Willis English D ED Woodward Meredith M Brown Elizabeth E Popmihajlov Zoran Z Saddier Patricia P Annunziato Paula W PW Halsey Neal A NA Gershon Anne A AA

Vaccine 20171122 52

<h4>Background</h4>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.<h4>Methods</h4>All post-marketing adverse experience (AE) r ...[more]

PMID: 29174682

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Project description:ObjectivesTo assess the safety of live attenuated herpes zoster vaccine live (ZVL) through cumulative analysis of near real-time, participant-based active surveillance from Australia's AusVaxSafety system.Design and settingZVL was funded in Australia for adults aged 70 years from November 2016, with a time-limited catch up programme for those up to 79 years. This cohort study monitored safety in the first two programme years through active surveillance at 246 sentinel surveillance immunisation sites.ParticipantsAdults aged 70-79 years vaccinated with ZVL who responded to an opt-out survey sent via automated short message service (SMS) 3 days following vaccination (n=17 458) or contributed supplementary data through a separate, opt-in online survey at 16 and 24 days following vaccination (n=346).Primary and secondary outcome measuresRates of overall and prespecified adverse events following immunisation (AEFI) by sex, concomitant vaccination and underlying medical condition. Signal detection methods (fast initial response cumulative summation and Bayesian updating analyses) were applied to reports of medical attendance.ResultsThe median age of participants was 72 years; 53% were female. The response rate following automated SMS was high (73% within 7 days of vaccination). Females were more likely than males to report any adverse event within 7 days of vaccination (RR 2.07, 95% CI 1.86 to 2.31); injection site reaction was the most commonly reported (2.3%, n=377). Concomitant vaccination was not associated with higher adverse event rates (RR 1.05, 95% CI 0.93 to 1.18). Rates of medical attendance were low (0.3%) with no safety signals identified. Supplementary opt-in survey data on later onset adverse events did not identify any difference in AEFI rates between those with and without underlying medical conditions.ConclusionsZVL has a very good safety profile in the first week after vaccination in older adults. Active, participant-based surveillance in this primary care cohort is an effective method to monitor vaccine safety among older adults and will be used as a key component of COVID-19 vaccine safety surveillance in Australia.

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

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

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

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

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