Evidence map›Paper›PMID 33766842›Full record

Observational studyBMJ open2021

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

Anastasia Phillips, Catherine Glover, Alan Leeb, Patrick Cashman, Parveen Fathima, Nigel Crawford, Thomas L Snelling, David Durrheim, Kristine Macartney

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.2field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Observational
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Anastasia PhillipsSchool of Public Health, The University of Sydney, Sydney, New South Wales, Australia aphi7007@uni.sydney.edu.au.ORCID http://orcid.org/0000-0001-7394-4561
Catherine GloverNational Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.
Alan LeebSmartVax, c/o Illawarra Medical Centre, Ballajura, Western Australia, Australia.
Patrick CashmanHunter New England Population Health, Newcastle, New South Wales, Australia.
Parveen FathimaWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia.
Nigel CrawfordSAEFVIC, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Thomas L SnellingSchool of Public Health, The University of Sydney, Sydney, New South Wales, Australia.
David DurrheimHunter New England Population Health, Newcastle, New South Wales, Australia.
Kristine MacartneyNational Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.
The University of Sydney · AUHunter New England Local Health District · AUChildren's Hospital at Westmead · AUIllawarra Health and Medical Research Institute · AURoyal Children's Hospital · AUThe Kids Research Institute Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 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.

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.

Indexed as

Watchful WaitingAgedAustraliaBayes TheoremCohort StudiesFemaleHerpes ZosterHerpes Zoster VaccineHumansMaleVaccinationHerpes Zoster Vaccineadverse eventspreventive medicineprimary carepublic health

Identifiers

PMID33766842
PMCPMC7996657
OpenAlexW3139383950

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.