Safety of live attenuated herpes zoster vaccine in Australian adults 70–79 years of age: an observational study using active surveillance

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, wi...

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Main Authors: Parveen Fathima, Thomas L Snelling, Catherine Glover, David Durrheim, Alan Leeb, Anastasia Phillips, Patrick Cashman, Nigel Crawford
Format: Article
Language:English
Published: BMJ Publishing Group 2021-03-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/11/3/e043880.full
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spelling doaj-0e35ad055f10442f983e43ca510444bb2021-07-02T13:10:32ZengBMJ Publishing GroupBMJ Open2044-60552021-03-0111310.1136/bmjopen-2020-043880Safety of live attenuated herpes zoster vaccine in Australian adults 70–79 years of age: an observational study using active surveillanceParveen Fathima0Thomas L Snelling1Catherine Glover2David Durrheim3Alan Leeb4Anastasia Phillips5Patrick Cashman6Nigel Crawford7Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, AustraliaSchool of Public Health, The University of Sydney, Sydney, New South Wales, AustraliaNational Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Westmead, New South Wales, AustraliaHunter New England Population Health, Newcastle, New South Wales, AustraliaSmartVax, c/o Illawarra Medical Centre, Ballajura, Western Australia, AustraliaSchool of Public Health, The University of Sydney, Sydney, New South Wales, AustraliaHunter New England Population Health, Newcastle, New South Wales, AustraliaSAEFVIC, Murdoch Children's Research Institute, Parkville, Victoria, AustraliaObjectives 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.https://bmjopen.bmj.com/content/11/3/e043880.full
collection DOAJ
language English
format Article
sources DOAJ
author Parveen Fathima
Thomas L Snelling
Catherine Glover
David Durrheim
Alan Leeb
Anastasia Phillips
Patrick Cashman
Nigel Crawford
spellingShingle Parveen Fathima
Thomas L Snelling
Catherine Glover
David Durrheim
Alan Leeb
Anastasia Phillips
Patrick Cashman
Nigel Crawford
Safety of live attenuated herpes zoster vaccine in Australian adults 70–79 years of age: an observational study using active surveillance
BMJ Open
author_facet Parveen Fathima
Thomas L Snelling
Catherine Glover
David Durrheim
Alan Leeb
Anastasia Phillips
Patrick Cashman
Nigel Crawford
author_sort Parveen Fathima
title Safety of live attenuated herpes zoster vaccine in Australian adults 70–79 years of age: an observational study using active surveillance
title_short Safety of live attenuated herpes zoster vaccine in Australian adults 70–79 years of age: an observational study using active surveillance
title_full Safety of live attenuated herpes zoster vaccine in Australian adults 70–79 years of age: an observational study using active surveillance
title_fullStr Safety of live attenuated herpes zoster vaccine in Australian adults 70–79 years of age: an observational study using active surveillance
title_full_unstemmed Safety of live attenuated herpes zoster vaccine in Australian adults 70–79 years of age: an observational study using active surveillance
title_sort safety of live attenuated herpes zoster vaccine in australian adults 70–79 years of age: an observational study using active surveillance
publisher BMJ Publishing Group
series BMJ Open
issn 2044-6055
publishDate 2021-03-01
description 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.
url https://bmjopen.bmj.com/content/11/3/e043880.full
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