Safety of live attenuated herpes zoster vaccine in adults 70–79 years: A self-controlled case series analysis using primary care data from Australia’s MedicineInsight program

Totterdell, James; Phillips, Anastasia; Glover, Catherine; Chidwick, Kendal; Marsh, Julie A.; Snelling, Tom; Macartney, Kristine

doi:10.1016/j.vaccine.2020.03.054

Cited by 12 publications

(26 citation statements)

References 30 publications

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“…This is consistent with the knowledge that ZVL is only a moderately effective vaccine, with clinical trials15 16 estimating efficacy at 51.3% (95% CI 44.2% to 57.6%) against HZ in those aged ≥60 years and 37.6% in those aged ≥70 years over a 3-year follow-up period. Injection site reactions were the second most frequently reported AEFI in our study (19.2% of reports), similar to other vaccine safety studies,38 43 44 followed by vaccination error (11.7%).…”

Section: Discussionsupporting

confidence: 90%

Disseminated varicella zoster virus infection following live attenuated herpes zoster vaccine: descriptive analysis of reports to Australia’s spontaneous vaccine pharmacovigilance system, 2016–2020

et al. 2023

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ObjectivesTo examine the reported incidence and features of disseminated varicella zoster virus (VZV) infection following live attenuated herpes zoster vaccine live (ZVL: Zostavax, Merck) in immunocompromised people in Australia.Design and settingZVL was funded in 2016 in Australia for people aged 70 years, with a catch-up programme for those 71–79 years. From 2016 to 2020, three deaths due to disseminated vaccine-strain VZV infection occurred following inadvertent ZVL administration in individuals with varying levels of immunocompromise. This descriptive study examined 4 years of national surveillance data reported to the Therapeutic Goods Administration’s Adverse Event Monitoring System (AEMS). Denominator data for rates were from doses recorded in the Australian Immunisation Register.ParticipantsIndividuals vaccinated between 1 November 2016 and 31 December 2020 who experienced adverse event(s) following immunisation (AEFI) after ZVL recorded in the AEMS.Primary and secondary outcome measuresRates and outcomes of confirmed (Oka strain positive) or probable disseminated VZV infection, and inadvertent administration of ZVL in immunocompromised individuals.Results854 AEFI were reported from 1 089 966 doses of ZVL administered (78.4 per 100 000 doses). Of those, 14 were classified as confirmed (n=6, 0.55 per 100 000) or probable (n=8) disseminated VZV infection. The confirmed cases were all hospitalised, and most (5/6) were immunocompromised; three cases died. Thirty-seven individuals were reported as vaccinated despite a contraindication due to immunocompromise (3.4 per 100 000), with 12/37 (32%) hospitalised.ConclusionsDisseminated VZV is potentially life-threatening and occurs mostly in those with severe immunocompromise. Inadvertent administration of ZVL to immunocompromised individuals has occurred despite initial provider guidance and education. Multiple additional strategies to assist providers to identify contraindications have been implemented to prevent adverse outcomes.

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Section: Discussionsupporting

confidence: 90%

Disseminated varicella zoster virus infection following live attenuated herpes zoster vaccine: descriptive analysis of reports to Australia’s spontaneous vaccine pharmacovigilance system, 2016–2020

et al. 2023

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“…Only one (18) was a hospital-based study; the others were populationbased studies that analyzed database data. Participants in four studies (14)(15)(16)(17) were older than 65 years old. Four studies (14)(15)(16)(17) evaluated only ZVL (Zostavax), one study (18) evaluated only RZV (Shingrix), and the remaining study (19) evaluated both ZVL and RZV.…”

Section: Characteristics Of the Included Studies Investigating The As...mentioning

confidence: 99%

“…With the introduction of the zoster vaccine live (ZVL, Zostavax) in 2006 and the recombinant zoster vaccine (RCV, Shingrix) in 2017, HZ vaccination (HZV) has reduced the risk of developing HZ and postherpetic neuralgia (12,13). Some studies have examined the association between HZV and post-HZ stroke, but the findings have been inconsistent (14)(15)(16)(17)(18)(19). One study had a within-person study design but did not find a protective role of HZV (14).…”

Section: Introductionmentioning

confidence: 99%

Effects of herpes zoster vaccination and antiviral treatment on the risk of stroke: a systematic review and meta-analysis

et al. 2023

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BackgroundEvidence suggests that there is an increased risk of stroke after herpes zoster (HZ). However, reports on the effects of HZ vaccination (HZV) and antiviral treatment on stroke risk are inconsistent. Thus, we examined these associations in a meta-analysis.MethodsTo identify relevant studies, we searched three databases for articles published up to January 2023. Random-effect models were examined to determine overall pooled estimates and 95% confidence intervals (CIs).ResultsThis review included 12 observational studies (six on HZV and seven on antiviral treatment). When comparing vaccinated and unvaccinated patients, vaccination was found to be associated with a lower risk of stroke (OR, 0.78; 95% CI 0.68–0.9; P = 0.001). A meta-analysis of self-controlled case series (SCCS) revealed evidence of a reduced OR in individuals who received the vaccine (OR, 1.14; 95% CI 0.94–1.37; P = 0.181) compared with unvaccinated individuals (OR, 1.36; 95% CI 1.15–1.61; P < 0.001). Compared with untreated patients, antiviral therapy was not associated with a reduced risk of stroke (OR, 1.13; 95% CI 0.94–1.36; P = 0.201). The meta-analysis of the SCCS showed no evidence of a reduced OR in individuals who received antiviral therapy (OR, 1.33; 95% CI 1.17–1.51; P < 0.001) compared to untreated individuals (OR, 1.45; 95% CI 1.25–1.69; P < 0.001).ConclusionsThis meta-analysis suggests that the HZV, but not antiviral treatment, decreases the odds of developing stroke.

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“…Over the past decade, these data have been used by academics and NPS MedicineWise to inform industry and government agencies about primary care and post-market surveillance of medicines, informing policy and supporting quality improvement activities in general practice [15]. There are numerous reports and over 40 peer reviewed publications to date based on MedicineInsight data including studies investigating Australian opioid use [16,17], vaccination [18][19][20], and the management of chronic hepatitis C in general practice [21,22].…”

Section: Introductionmentioning

confidence: 99%

Evaluating the accuracy of data extracted from electronic health records into MedicineInsight, a national Australian general practice database

Daniels

Havard

Myton

et al. 2022

IJPDS

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IntroductionMedicineInsight is a database containing de-identified electronic health records (EHRs) from over 700 Australian general practices. Previous research validated algorithms used to derive medical condition flags in MedicineInsight, but the accuracy of data fields following EHR extractions from clinical practices and data warehouse transformation processes have not been formally validated. ObjectivesTo examine the accuracy of the extraction and transformation of EHR fields for selected demographics, observations, diagnoses, prescriptions, and tests into MedicineInsight. MethodsWe benchmarked MedicineInsight values against those recorded in original EHRs. Forty-six general practices contributing data to MedicineInsight met our eligibility criteria, eight were randomly selected, and four agreed to participate. We randomly selected 200 patients ≥ 18 years of age within each participating practice from MedicineInsight. Trained staff reviewed the original EHRs for the selected patients and recorded data from the relevant fields. We calculated the percentage of agreement (POA) between MedicineInsight and EHR data for all fields; Cohen's Kappa for categorical and intra-class correlation (ICC) for continuous measures; and sensitivity, specificity, and positive and negative predictive values (PPV/NPV) for diagnoses. ResultsA total of 796 patients were included in our analysis. All demographic characteristics, observations, diagnoses, prescriptions and random pathology test results had excellent (> 90%) POA, Kappa, and ICC. POA for most recent pathology/imaging test was moderate (81%, [95% CI: 78% to 84%]). Sensitivity, specificity, PPV, and NPV were excellent (> 90%) for all but one of the examined diagnoses which had a poor PPV. ConclusionsOverall, our study shows good agreement between the majority of MedicineInsight data and those from original EHRs, suggesting MedicineInsight data extraction and warehousing procedures accurately conserve the data in these key fields. Discrepancies between test data may have arisen due to how data from pathology, radiology and other imaging providers are stored in EHRs and MedicineInsight and this requires further investigation.

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Safety of live attenuated herpes zoster vaccine in adults 70–79 years: A self-controlled case series analysis using primary care data from Australia’s MedicineInsight program

Cited by 12 publications

References 30 publications

Disseminated varicella zoster virus infection following live attenuated herpes zoster vaccine: descriptive analysis of reports to Australia’s spontaneous vaccine pharmacovigilance system, 2016–2020

Disseminated varicella zoster virus infection following live attenuated herpes zoster vaccine: descriptive analysis of reports to Australia’s spontaneous vaccine pharmacovigilance system, 2016–2020

Effects of herpes zoster vaccination and antiviral treatment on the risk of stroke: a systematic review and meta-analysis

Evaluating the accuracy of data extracted from electronic health records into MedicineInsight, a national Australian general practice database

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