Objectives To 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 setting ZVL 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.
Participants Adults 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 measures Rates 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.
Results The 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.
Conclusions ZVL 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.
- public health
- adverse events
- primary care
- preventive medicine
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Contributors AP, CG, TLS, NC and KM made substantial contributions to the conception or design of the manuscript. AP and CG were responsible for drafting the manuscript and conducting all data analyses, with the exception of signal detection analyses, which were performed by PF. TLS and PF were responsible for the conceptualisation and execution of the weekly safety signal detection analyses. AL, as codeveloper of the SmartVax system, served as the system operator and advisor regarding SmartVax data. PC and DD served as system operator and advisors regarding Vaxtracker data. PC, AL, TLS, DD and KM were integral to the design and development of the AusVaxSafety vaccine safety surveillance system and served as key vaccine safety experts. All authors made substantial contributions to the interpretation of data for the work and revised the manuscript critically for important intellectual content. All authors had final approval of the version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding AusVaxSafety surveillance was funded under a contract with the Australian Government Department of Health (grant number NA). AP receives PhD stipend funding from the National Health and Medical Research Council (NHMRC) and the Royal Australasian College of Physicians (RACP) (grant number NA). TLS is supported by a Career Development Fellowship from the National Health and Medical Research Council (GNT1111657).
Competing interests All authors except AP are either located at organisations that hold the AusVaxSafety contract from the Australian Government Department of Health or are subcontract holders.
Patient consent for publication Not required.
Ethics approval This study was approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee (HREC/16/SCHN/19). AusVaxSafety operates under this approval as well as approval obtained from the Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (NREEC15-007).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data may be obtained from a third party and are not publicly available. AusVaxSafety compiles ongoing, deidentified surveillance data of patient-reported adverse events for specific vaccines as contracted by the Australian Government Department of Health. Summarised results are publicly available on the AusVaxSafety website (www.ausvaxsafety.org.au) but AusVaxSafetydata sets are not publicly available.
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