Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia

doi:10.1136/bmjopen-2018-023263

Observational Study

. 2018 Oct 18;8(10):e023263.

doi: 10.1136/bmjopen-2018-023263.

Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia

Alexis J Pillsbury¹, Catherine Glover¹, Peter Jacoby², Helen E Quinn^{1

3}, Parveen Fathima², Patrick Cashman⁴, Alan Leeb^{5

6}, Christopher C Blyth^{2

7

8

9}, Michael S Gold¹⁰, Thomas Snelling^{2

8

11

12}, Kristine K Macartney^{1

3

13}

Affiliations

¹ National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.
² Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.
³ Discipline of Paediatrics and Child Health, The University of Sydney, Sydney, New South Wales, Australia.
⁴ Hunter New England Population Health, Newcastle, New South Wales, Australia.
⁵ SmartVax, c/o Illawarra Medical Centre, Ballajura, Western Australia, Australia.
⁶ Illawarra Medical Centre, Ballajura, Western Australia, Australia.
⁷ School of Medicine, University of Western Australia, Perth, Western Australia, Australia.
⁸ Princess Margaret Hospital for Children, Perth, Western Australia, Australia.
⁹ PathWest Laboratory Medicine WA, Department of Microbiology, QEII Medical Centre, Perth, Western Australia, Australia.
¹⁰ Discipline of Paediatrics, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.
¹¹ School of Public Health, Curtin University, Perth, Western Australia, Australia.
¹² Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.
¹³ Department of Microbiology and Infectious Disease, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.

PMID: 30341132
PMCID: PMC6196842
DOI: 10.1136/bmjopen-2018-023263

Observational Study

Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia

Alexis J Pillsbury et al. BMJ Open. 2018.

. 2018 Oct 18;8(10):e023263.

doi: 10.1136/bmjopen-2018-023263.

Authors

Affiliations

¹ National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.
² Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.
³ Discipline of Paediatrics and Child Health, The University of Sydney, Sydney, New South Wales, Australia.
⁴ Hunter New England Population Health, Newcastle, New South Wales, Australia.
⁵ SmartVax, c/o Illawarra Medical Centre, Ballajura, Western Australia, Australia.
⁶ Illawarra Medical Centre, Ballajura, Western Australia, Australia.
⁷ School of Medicine, University of Western Australia, Perth, Western Australia, Australia.
⁸ Princess Margaret Hospital for Children, Perth, Western Australia, Australia.
⁹ PathWest Laboratory Medicine WA, Department of Microbiology, QEII Medical Centre, Perth, Western Australia, Australia.
¹⁰ Discipline of Paediatrics, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.
¹¹ School of Public Health, Curtin University, Perth, Western Australia, Australia.
¹² Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.
¹³ Department of Microbiology and Infectious Disease, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.

PMID: 30341132
PMCID: PMC6196842
DOI: 10.1136/bmjopen-2018-023263

Abstract

Objective: To actively solicit adverse events experienced in the days following immunisation with quadrivalent inactivated influenza vaccine using Australia's near real-time, participant-based vaccine safety surveillance system, AusVaxSafety.

Design and setting: Observational cohort study conducted in 194 sentinel surveillance immunisation sites (primary care, hospital and community-based clinics) across Australia.

Participants: Individuals aged ≥6 months who received a routine seasonal influenza vaccine at a participating site (n=102 911) and responded to a survey (via short message service or email) sent 3 days after vaccination about adverse events experienced (n=73 892; 71.8%).

Main outcome measure: Near real-time and cumulative participant-reported rates of any adverse event, fever or medical attendance experienced within 3 days after vaccination overall, by brand, age, pregnancy status and concomitant vaccine receipt.

Results: Participant median age was 57 years (range: 6 months to 102 years); 58.1% (n=42 869) were female and 2.7% (n=2018) were pregnant. Near real-time fast initial response cumulative summation and Bayesian analyses of weekly event rates did not demonstrate a safety signal. Children aged 6 months to 4 years had higher event rates (522/6180; 8.4%) compared with older ages; participants aged ≥65 years reported fewer events (1695/28 154; 6.0%). There were no clinically significant differences in safety between brands, by age group or overall. Cumulative data analysis demonstrated that concomitant vaccination was associated with increased rates of fever (2.1% vs 0.8%) and medical attendance (0.8% vs 0.4%), although all rates were low and did not exceed expected levels.

Conclusions: Novel, postmarketing AusVaxSafety surveillance demonstrated comparable and expected safety outcomes for the 2017 quadrivalent inactivated influenza vaccine brands used in Australia. These near real-time, participant-reported data are expected to encourage confidence in vaccine safety and promote uptake.

Keywords: active surveillance; epidemiology; vaccine safety.

PubMed Disclaimer

Conflict of interest statement

Competing interests: All authors are either located at organisations that hold the AusVaxSafety contract from the Australian Government Department of Health or are subcontract holders.

Figures

**Figure 1**
Counts of enrollees and participants by epidemiological week and age group or pregnancy status (A: 6 months to 4 years; B: 5–64 years; C: ≥65 years; D: Pregnant). Each bar displays the number of participants (dark grey) out of the total number of enrollees (light grey) for each week.

See this image and copyright information in PMC

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References

1. Palache A, Abelin A, Hollingsworth R, et al. . Survey of distribution of seasonal influenza vaccine doses in 201 countries (2004-2015): The 2003 World Health Assembly resolution on seasonal influenza vaccination coverage and the 2009 influenza pandemic have had very little impact on improving influenza control and pandemic preparedness. Vaccine 2017;35:4681–6. 10.1016/j.vaccine.2017.07.053 - DOI - PubMed
1. Agency EM. Guideline on influenza vaccines non-clinical and clinical module. London, UK: European Medicines Agency, 2016.
1. Armstrong PK, Dowse GK, Effler PV, et al. . Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine. BMJ Open 2011;1:e000016 10.1136/bmjopen-2010-000016 - DOI - PMC - PubMed
1. Blyth CC, Richmond PC, Jacoby P, et al. . The impact of pandemic A(H1N1)pdm09 influenza and vaccine-associated adverse events on parental attitudes and influenza vaccine uptake in young children. Vaccine 2014;32:4075–81. 10.1016/j.vaccine.2014.05.055 - DOI - PubMed
1. The Royal Children’s Hospital Melbourne. Vaccination: perspectives of Australian parents. The Royal Children’s Hospital National Child Health Poll, 2017.

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[1] Palache A, Abelin A, Hollingsworth R, et al. . Survey of distribution of seasonal influenza vaccine doses in 201 countries (2004-2015): The 2003 World Health Assembly resolution on seasonal influenza vaccination coverage and the 2009 influenza pandemic have had very little impact on improving influenza control and pandemic preparedness. Vaccine 2017;35:4681–6. 10.1016/j.vaccine.2017.07.053 - DOI - PubMed

[2] Palache A, Abelin A, Hollingsworth R, et al. . Survey of distribution of seasonal influenza vaccine doses in 201 countries (2004-2015): The 2003 World Health Assembly resolution on seasonal influenza vaccination coverage and the 2009 influenza pandemic have had very little impact on improving influenza control and pandemic preparedness. Vaccine 2017;35:4681–6. 10.1016/j.vaccine.2017.07.053 - DOI - PubMed

[3] Agency EM. Guideline on influenza vaccines non-clinical and clinical module. London, UK: European Medicines Agency, 2016.

[4] Agency EM. Guideline on influenza vaccines non-clinical and clinical module. London, UK: European Medicines Agency, 2016.

[5] Armstrong PK, Dowse GK, Effler PV, et al. . Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine. BMJ Open 2011;1:e000016 10.1136/bmjopen-2010-000016 - DOI - PMC - PubMed

[6] Armstrong PK, Dowse GK, Effler PV, et al. . Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine. BMJ Open 2011;1:e000016 10.1136/bmjopen-2010-000016 - DOI - PMC - PubMed

[7] Blyth CC, Richmond PC, Jacoby P, et al. . The impact of pandemic A(H1N1)pdm09 influenza and vaccine-associated adverse events on parental attitudes and influenza vaccine uptake in young children. Vaccine 2014;32:4075–81. 10.1016/j.vaccine.2014.05.055 - DOI - PubMed

[8] Blyth CC, Richmond PC, Jacoby P, et al. . The impact of pandemic A(H1N1)pdm09 influenza and vaccine-associated adverse events on parental attitudes and influenza vaccine uptake in young children. Vaccine 2014;32:4075–81. 10.1016/j.vaccine.2014.05.055 - DOI - PubMed

[9] The Royal Children’s Hospital Melbourne. Vaccination: perspectives of Australian parents. The Royal Children’s Hospital National Child Health Poll, 2017.

[10] The Royal Children’s Hospital Melbourne. Vaccination: perspectives of Australian parents. The Royal Children’s Hospital National Child Health Poll, 2017.

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Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia

Affiliations

Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia

Authors

Affiliations

Abstract

Conflict of interest statement

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