Surveillance of adverse events following H1N1/09 influenza immunisation in Victoria, Australia

Abstract

BACKGROUND: The H1N1 pandemic in 2009 required a systematic coordinated response, which in Australia included a monovalent (H1N1/09) vaccine (Panvax?). SAEFVIC (Surveillance of Adverse Events Following Vaccination In the Community) is the Victorian, Australia state-based vaccine safety unit. The aim of the study was to review SAEFVIC reports of adverse events following immunisations (AEFI) temporally associated with H1N1/09 vaccines [monovalent and Trivalent Influenza Vaccines (TIV)]. METHODS: 1) Analysis of AEFI related to H1N1/09 vaccines reported to SAEFVIC from September 2009 to December 2010; 2) Review of febrile convulsions (ICD-10 code R56.0), in children under 5 years of age presenting to the Royal Children’s Hospital (RCH) Melbourne, Emergency Department between 1 March-30 April 2010. The presentation details and immunisation history were clarified by a telephone interview. RESULTS: 1) There were 659 reports of 749 adverse events following H1N1 vaccines. Among the TIV group, Fluvax had the most AEFI reported, with 77 per 100,000 doses distributed. Serious AEFI temporally associated with H1N1/09 vaccines included: 3 deaths, 2 anaphylactic reactions, and 3 GuillainBarre Syndrome. There were 7 reports of drug administration error; 2) There were 179 presentations with fever and 67 reported febrile convulsions out of 11025 presentations (0.61%), 11 following H1N1 vaccines. Fluvax? was associated with 55% (6/11) reports. The mean onset time of AEFI was 13.2 hours post vaccination, and there was complete resolution of symptoms in allcases with no significant morbidity. CONCLUSION: Consistent with other Australian states in 2010, there was a TIV brand specific [Fluvax?] increase in febrile convulsions post vaccination. As a result this vaccine is no longer licensed for children <5 years of age. Comprehensive passive and active surveillance for AEFI needs to be incorporated into future pandemic planning.

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Tran, D. , Clothier, H. , Buttery, J. and Crawford, N. (2012) Surveillance of adverse events following H1N1/09 influenza immunisation in Victoria, Australia. Natural Science, 4, 1065-1073. doi: 10.4236/ns.2012.412135.

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1] Patterson, K.D. and Pyle, G.F. (1991) The geography and mortality of the 1918 influenza pandemic. Bulletin of the History of Medicine, 65, 4-21.
[2] Peiris, J.S., Poon, L.L. and Guan, Y. (2009) Emergence of a novel swine-origin influenza A virus (S-OIV) H1N1 virus in humans. Journal of Clinical Virology, 45, 169-173. doi:10.1016/j.jcv.2009.06.006
[3] Souayah, N., et al. (2007) Guillain-Barre syndrome after vaccination in United States a report from the CDC/FDA Vaccine Adverse Event Reporting System. Vaccine, 25, 5253-5255. doi:10.1016/j.vaccine.2007.03.053
[4] Haber, P., et al. (2004) Guillain-Barre syndrome following influenza vaccination. Journal of the American Medical Association, 292, 2478-2481. doi:10.1001/jama.292.20.2478
[5] Nolan, T., et al. (2010) Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: A randomized trial. Journal of the American Medical Association, 303, 37-46. doi:10.1001/jama.2009.1911
[6] Therapeutic Goods Administration (2009) TGA approves vaccine against Pnademic (H1N1) 2009 influenza. http://www.tga.gov.au/safety/alerts-medicine-pandemic-influenza-090918.htm
[7] Department of Health Ageing (2010) The Facts on swine flu. D.o.H. Ageing, Canberra. http://www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr10-nr-nr053.htm
[8] National Health and Medical Research Council (2008) The Australian Immunisation Handbook. 9th Edition, National Capital Press, Canberra.
[9] Clothier, H.J., et al. (2011) Surveillance of adverse events following immunisation: The model of SAEFVIC, Victoria. Communicable Diseases Intelligence, 35, 294-298.
[10] Therapeutic Goods Administration (2010) Overview of vaccine regulation and safety monitoring and investigation into adverse events following 2010 seasonal influenza vaccination in young children. http://www.tga.gov.au/pdf/alerts-medicine-seasonal-flu-101008.pdf
[11] Van Buynder, P.G., et al. (2011) Marketing paediatric influenza vaccination: Results of a major metropolitan trial. Influenza and Other Respiratory Viruses, 5, 33-38. doi:10.1111/j.1750-2659.2010.00167.x
[12] Armstrong, P.K., et al. (2011) Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine. BMJ Open, 1, e000016. doi:10.1136/bmjopen-2010-000016
[13] Bishop, J. (2010) Seasonal influenza vaccine and young children. D.o.H.a. Ageing, Canberra.
[14] Therapeutic Goods Administration (2010) Investigation into Febrile Convulsions in young children after Seasonal Influenza Vaccination. Latest findings and recommendations 30th July 2010. D.o.H.a. Ageing, Canberra.
[15] Stokes, B. (2010) Ministerial review into the public health response into the adverse events to the seasonal influenza vaccine. D.o.H. Government of WA, Canberra.
[16] Surveillance of adverse events following vaccination in the community. SAEFVIC adverse events reporting, 2007. http://www.saefvic.org.au
[17] Australian Bureau of Statistics (2008) Population projections Australia 2006-2101. http://www.abs.gov.au/ausstats/abs@.nsf/detailspage/3222.02006%20to%202101?opendocument.
[18] Australian Institute of Health and Wellbeing (2011) 2009 adult vaccination survey: Summary results. Cat. no. PHE 135. http://www.aihw.gov.au/publication-detail/?id=10737418409
[19] Australian Institute of Health and Wellbeing (2010) 2010 pandemic vaccination survey: Summary results. Cat. no. PHE128. http://www.aihw.gov.au/workarea/downloadasset.aspx?id=6442460016
[20] Mak, D.B., et al., Pandemic (H1N1) 2009 influenza vaccination coverage in Western Australia. Med J Aust, 2010. 193(7): p. 401-4.
[21] Mahajan, D., et al., (2010) Annual report: Surveillance of adverse events following immunisation in Australia, 2009. Communicable Diseases Intelligence, 34, 259-276.
[22] Vellozzi, C., et al., (2010) Adverse events following influenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting System, United States, October 1, 2009-January 31, 2010. Vaccine, 28, 7248-7255. doi:10.1016/j.vaccine.2010.09.021
[23] Liang, X.F., et al. (2011) Safety of influenza A (H1N1) vaccine in postmarketing surveillance in China. The New England Journal of Medicine, 364, 638-647. doi:10.1056/NEJMoa1008553
[24] Gosbell, I.B., et al. (2010) Immunisation and multi-dose vials. Vaccine, 28, 6556-6561. doi:10.1016/j.vaccine.2010.07.052
[25] Evans, D., Cauchemez, S. and Hayden, F.G. (2009) “Prepandemic” immunization for novel influenza viruses, “swine flu” vaccine, Guillain-Barre syndrome, and the detection of rare severe adverse events. The Journal of Infectious Diseases, 200, 321-328. doi:10.1086/603560
[26] Hughes, R.A. and D.R. Cornblath, (2005) Guillain-Barre syndrome. Lancet, 366, 1653-1666. doi:10.1016/S0140-6736(05)67665-9
[27] Department of Health Ageing (2011) Review of Australia’s health sector response to pandemic (H1N1) 2009, lessons identified. D.o.H.a, Canberra.
[28] Crawford, N.W. (2011) GBS active: Targeted active surveillance for Guillain-Barre syndrome following the introduction of H1N1 vaccines in victoria, Australia. World Society of Paediatric Infectious Diseases Conference, Melbourne, 16-19 November 2011.
[29] Blyth, C.C., et al. (2011) Trivalent influenza vaccine and febrile adverse events in Australia, 2010: Clinical features and potential mechanisms. Vaccine, 29, 5107-5113. doi:10.1016/j.vaccine.2011.05.054
[30] Horvath, J. (2010) Review of the management of adverse events associated with Panvax and Fluvax. D.o.H. Ageing, Canberra.
[31] Kelly, H.A., et al. (2011) Adverse events associated with 2010 CSL and other inactivated influenza vaccines. Medical Journal of Australia, 195, 318-320. doi:10.5694/mja11.10941
[32] Department of Health Ageing (2010) Summary of ATAGI recommendations for selection of seasonal influenza vaccine for children >6 months to <5 years, adults and other risk groups. http://www.healthemergency.gov.au/internet/healthemergency/publishing.nsf/Content/2723D54E78BF5739CA2576400027E1E9/$File/atagi-TIV-30jul10.pdf
[33] Centers for Disease Control and Prevention (2010) Media statement: ACIP recommendation for use of CSL influenza vaccine. http://www.cdc.gov/media/pressrel/2010/s100806.htm

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