Revised: 27 February 2014
Publications
Seasonal Flu Vaccine - Spontaneous Reporting in 2011
Prescriber Update 33(1): 5-6
March 2012
Updated: 27 February 2014
The Centre for Adverse Reactions Monitoring (CARM) and Medsafe thank everyone who contributed to the monitoring of the flu vaccine last season by reporting suspected adverse reactions.
In 2011, approximately 200 reports of adverse events suspected to be related to influenza vaccination were received by CARM. This compares with over 400 reports received in 2010, when concerns were raised about cases of fevers and febrile convulsions in children.
The funded vaccines in 2011 were Fluvax and Fluarix. Fluarix was recommended by the Ministry of Health for eligible children under nine years of age.
Use in Children
In 2011, there was only one report of febrile convulsions suspected to be associated with influenza vaccine (Vaxigrip). There were four reports of death coincident with influenza immunisation in 2011*. CARM did not consider any of these reports to be caused by the vaccine.
Fever was reported in nine children, including one child less than nine years of age who received Fluvax. There was one report of an almost immediate allergic reaction (including urticaria and periorbital oedema). The child was appropriately treated and recovered without sequelae.
Guillain-Barré Syndrome
There were two instances of patients in their 70’s experiencing Guillain-Barré syndrome following immunisation. However, information about possible confounding factors, such as prior infections, was not provided.
Epidemiological studies have not consistently found an association between Guillain-Barré syndrome and influenza vaccines, with the reporting rate for these events remaining lower than the background rate in the general population1-3.
Conclusions
After an analysis of reports received in New Zealand in 2011, CARM considered the nature of reports was as expected for vaccine related adverse events.
Next Season
The strains of influenza to be used in next season’s (2012) vaccine will remain unchanged, as do the PHARMAC funded brands (Fluvax and Fluarix). For eligible children under nine years of age, Fluarix continues to be the recommended influenza vaccine.
References
- Haber P, Sejvar J, Mikaeloff Y, et al. 2009. Vaccines and Guillain-Barré syndrome. Drug Safety, 32(4): 309-323
- Stowe J, Andrews N, Wise L, et al. 2006. Bell’s palsy and parenteral inactivated influenza vaccine. Human Vaccines, 2(3): 110-112
- Black S, Eskola J, Siegrist CA, et al. 2009. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines. Lancet, 374(9707): 2115-2122
Update
* The sentence above may be misleading in that it infers that the four reports of death in 2011 coincident with seasonal flu vaccine were in children. Please note that these four reports were all in adults.
