The large number of adverse reactions to influenza vaccine this year led the government to suspend the vaccine for children across Australia. Nationally, there were 1,729 adverse events reported to the Therapeutic Goods Administration (TGA). After analysis the TGA stated there were 1,152 reports of fever and 123 reports of convulsions in children under 5 within 24 hours of the vaccine being administered.
In Western Australia (WA) 517 children had adverse reactions, of which 72 had febrile convulsions. Prof. Collignon, director of the infectious diseases unit at Canberra hospital states that this is a very high rate of adverse reactions when the risk of dying of swine flu last winter was one in a million). The adverse reactions were linked to CSL’s 2010 trivalent influenza vaccine Fluvax and Fluvax Junior.
In April 2010 many children around Australia reacted adversely to the childhood influenza vaccine. In Queensland one child died within 12 hours of receiving the vaccine and the coronial inquest did not rule out the possibility that the vaccine caused the death. Western Australia had the largest number of adverse reactions due to the influenza immunization campaign that was implemented in this state in 2008. Western Australia is the only Australian state to have promoted influenza vaccine free to children 6 months to 5 years of age in a campaign designed to determine whether immunizing children will reduce the transmission of influenza in the community.
The stated purpose of the WA influenza immunization campaign for children was ‘to protect children and to see if it reduces the transmission of influenza in the community.’ The health department does not claim that influenza is a serious risk to the majority of children. Despite this however, they promoted free childhood influenza vaccines to parents in 2008 through an advertising campaign in the media.
The advertisements used the deaths of three children in 2007 to suggest influenza is a serious risk to all children. Further examination of these deaths revealed that the cause of death for these three children was inconclusive and still subject to a coroner’s report at the time of the advertisement. The Director of the Communicable Disease Control Directorate stated the information on these deaths was restricted to the public yet the information was being used in a state based media campaign. At the time of the advertisement it was known that one of the children had been confirmed with Influenza A and all three children had pneumonia. This represents unconfirmed anecdotal evidence and is not an indication of the actual risk of influenza to the majority of children.
When the program was suspended on 22nd April the TGA had only received 25 reports of febrile convulsions in children (under 10) across Australia. In fact, there were 123 febrile convulsions and the discrepancy was a result of the inadequate surveillance system for adverse reactions. Prof. Collignon states that Australia does not have adequate post-vaccine surveillance to establish the risk of vaccines and it is known that when adverse reactions are investigated they are not reported consistently or systematically. Prof. Bryant Stokes describes the inadequacies that exist in the reporting of adverse reactions to vaccines. The reporting system is a dual system allowing health providers to report reactions either to the Commonwealth TGA or the Public Health Division of the State Department of Health. It is paper – based rather than electronic and does not deliver information in an efficient manner. The reactions are dispersed between the two centers resulting in a lack of knowledge at any given time of the number or rate of reactions occurring.
In order to determine the actual risk of influenza to the majority of children we need to examine the mortality data. The mortality data for influenza indicates that the number of deaths for children less than five years of age in Western Australia is between zero – three deaths per year. This has been the number of deaths for the last four decades and is similar to all other Australian states. National deaths from influenza in children under five have been between zero – three annually since 1977. These statistics do not justify the general vaccination of children for influenza and suggest that influenza is a very low risk to the majority of children. It is stated in the Cochrane review of influenza vaccines that the consequences of influenza in children and adults is mainly absenteeism from school and work. The hospitalization and mortality data shows that the risk of complications and deaths from influenza is greatest in people over 65 years old and that there is an increased risk of complications from influenza in children under 2.
A decision to use an influenza vaccine for all children should be based upon accurate information of the risk of the disease and its associated complications versus the effectiveness and safety of the vaccine. In addition, the combination of vaccines children are receiving must be considered because today’s children are receiving multiple vaccines and inclusion of the influenza vaccine results in some children receiving up to 14 vaccines before one year of age.
Vaccines contain antibiotics, preservatives and aluminium adjuvants that are known allergens and neurotoxins. The cumulative and synergistic effects of the increased number of vaccines in children must be considered because it is known that the chemicals in vaccines can interact and produce latent effects in animal cells. This means adverse events can occur months or years after the administration of the vaccine.
A review of the TGA, the regulatory body responsible for monitoring the safety of vaccines, illustrated the conflict of interest that exists within this government department. The TGA works closely with government departments in its role as the government licensing agent for new vaccines and in its contrasting role of ensuring public safety by regulating vaccines. The TGA is responsible for monitoring and reporting the adverse reactions to the vaccines that it licenses. It is also fully funded by the pharmaceutical/therapeutic goods industry. This conflict of roles performed by the TGA cannot result in an objective assessment of vaccines and Professor Stokes has advised the roles should be separated. The TGA has stated it will separate the functions within the TGA but Prof. Stokes believes this will not go far enough.
The evidence from the influenza campaign in children does not indicate that the TGA is adequately monitoring the safety of vaccines. CSL funded the only Australian clinical trial of the monovalent H1N1 pandemic vaccine and the TGA was aware of the data that indicated a high number of adverse events from this limited trial before it approved the vaccine for children, pregnant women and adults. The trials for Panvax (monovalent H1N1 vaccine) were underpowered to detect the rate of adverse reactions in children and there were no clinical trials of Fluvax/Fluvax Junior (trivalent seasonal influenza vaccine) before it was promoted for use in young children.
This vaccine was rushed onto the market after the government stockpiled $131 million of ‘swine’ influenza vaccine prior to establishing the safety of this vaccine. In addition, there is little incentive for manufacturers to properly investigate the safety of vaccines because the manufacturers are indemnified for damages caused to users. The Ministerial Review into the influenza vaccine has shown that adequate regulations to protect the public interest are not in place.
References:
1.Collignon P, Doshi P, Jefferson T, 2010, Adverse events following influenza vaccination in Australia – should we be surprised? BMJ Rapid Responses Published 7 May 2010
2.Barrett R, September 11-12, 2010, Flu shot not ruled out in child death, The Week-end Australian, p.3.
3.Government of Western Australia, Department of Health,
a)Media Release 15th February 2008, Free vaccines to help fight child influenza.
b)Communicable Diseases Control Directorate, Van Buynder P, June 2008
c)Childhood Immunisation 2009
4.Western Australian Government, Dept. Health, 2008, Flu vaccination advertisement, The West Australian Newspaper, 6th July 2007. www.public.health.wa.gov.au
5.Australian Government, Australian Institute of Health and Welfare, National Mortality Database, GRIM Book Influenza, 2005.
6.Heikkinen T, Booy R, Campins M, Finn A, Olcen P, Peltola H, Rodrigo C, Schmitt H, Schumacher F, Teo S, Weil-Olivier C, 2006, Should healthy children be vaccinated against influenza? European Journal of Pediatrics, 165: 223-228, DOI 10.1007/s00431-005-0040-9
7.Jefferson T, Rivetti A, Harnden A, Di Pietrantonj C, Demicheli V, 2008,Vaccines for preventing influenza in healthy children, Cochrane Database of Systematic Reviews, Issue 2, 2008, Art. No.: CD004879.
8.Eldred BE et al, 2006, “Vaccine components and constituents: responding to consumer concerns”, Medical Journal of Australia, 184: No. 4: pp.170-175
9.Gilbert SG, 2004, A Small Dose of Toxicology: the health effects of common chemicals, Boca Raton Fla, CRC Press
10.Australian Government Department of Health and Ageing. Therapeutic Goods Association. Investigation into febrile reactions in young children following 2010 seasonal trivalent vaccination. 2 Jul 2010. Available from: http://www.tga.gov.au/alerts/medicines/fluvaccine-report100702.htm
11.Stokes B, Government of Western Australia, Department of Health, August 2010, Ministerial Review into the Public Health Response into the Adverse Events to the seasonal Influenza Vaccine, www.health.wa.gov.au
12.Bita N, Consumer editor, 29th September 2010, A flu jab too close for comfort, The Australian, www.theaustralian.com.au/news/features/a-flu-jab-too-close-for-comfort/story-e6frg6z6-1225931148903