Why are we using flu vaccines in children?

The following report has been provided to the WA Minister for Health, Dr Hames. It was presented last year at the National Health Promotion conference in Perth (prophetically) by Judy Wilyman, a PhD Candidate at Murdoch University. Please read this and ask yourself, if this information is out in the medical community and has been known about for some time, why did we ever decide to use influenza vaccines in children?

Parents, it is time for you to stop giving up responsibility for your children's health and to become fully informed on both sides of this vital issue.

Influenza Mass Immunisation Campaigns

Western Australia is the first Australian State to participate in a campaign offering free influenza vaccine to children. This campaign is being conducted through the Telethon Institute for Children’s Health Research and funded by the vaccine companies – CSL laboratories and Sanofi - Pasteur at a cost of $1.2 million (1a). The stated purpose of the trial is a pre-emptive attempt to protect young children from flu and to assess the efficacy of the vaccine in preventing influenza in the community (1a).

The Health Department is using evidence from other countries to claim that influenza is a serious risk to children (1b). Australia is adopting the guidelines set by the CDC’s Advisory Committee on Immunisation Practices (ACIP) which state that annual vaccination of all children aged 6 months to 4 years should continue to be a primary focus of vaccination efforts because these children are at higher risk for influenza complications compared to older children (2). This statement does not claim that these children are at ‘serious’ risk from influenza complications only that they are at ‘higher’ risk than older children. The ACIP also recommends that annual vaccination be administered to all children aged 5-18 years (2).

Western Australia adopted this initiative in autumn 2008 and used the deaths of three children in 2007 to suggest influenza is a serious risk to all children (3). 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 (1b) The Director of the flu campaign, Dr. Paul Van Buynder stated the information on these deaths was restricted to the public yet it was being used in a national campaign to promote free flu vaccine to children (1b). These deaths represent anecdotal evidence of the risk of influenza to children and it was revealed in the media that only one of the children was identified with Influenza A as opposed to all three children that the vaccine advertisement implied (3).

In order to determine if influenza is a serious risk to children we need to examine the deaths to influenza in this age group over several decades. An investigation of the mortality data for flu indicates that the death rate for children under 5 years of age in Western Australia is between 0 – 3 deaths per year (4). This has been the death rate for the last 4 decades and it suggests that flu is a very low risk to children. A proper assessment of the risk of this disease would also include the social circumstances surrounding deaths due to flu, as infectious diseases are associated with poor living standards and other social factors. Many children are also hospitalized with complications due to flu including asthma, croup, bronchitis, pneumonia. 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.

Today’s children receive multiple vaccines and inclusion of the influenza vaccine results in some children receiving up to 14 vaccines before five years of age. This factor must also be considered when weighing up the risks of diseases as vaccines contain antibiotics, preservatives and aluminium adjuvants that are known allergens and neurotoxins (5). It is also necessary to examine the evidence supporting the claim that the vaccine is effective in preventing influenza in the community.

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 (6). Australian mortality statistics due to influenza also do not support the claim that influenza is a serious risk to children (4). The hospitalization and mortality data shows that the risk of complications of influenza is greatest in people over 65 years old and that there is an increased risk of complications in children under 2 (4). If children are not at serious risk from influenza we must question why the vaccine is being included in the recommended childhood schedule.

The purpose of a campaign to immunize all children with flu vaccine could be to determine if immunization of children reduces the transmission of flu in the community and therefore reduces hospitalization and deaths due to flu in the group at most risk from this disease – elderly people. In this case we must debate the ethics of adding another vaccine to the childhood schedule in order to protect the community as opposed to promoting the vaccine to children because flu is a serious risk to their health.

Influenza is a disease that is caused by many viruses however the vaccine only protects against one, two or three strains depending on the type of vaccine used. Flu viruses spread easily and new strains develop regularly (7).The World Health Organization (WHO) recommends which strains should be included in the vaccine for each new season (7). This prediction occurs a year in advance in order to have the flu vaccine ready for the new season. Scientists must predict which strains of the virus will be most severe and the vaccine will only be effective if a good match has been made.

This is another reason why it is important to analyze hospitalization and mortality data to ensure the success of this program. An assessment of this data will confirm whether predicting the most severe strain of influenza virus a year in advance is successful. The desired outcome of the campaign is to reduce the incidence of influenza disease and complications in the population and an analysis of hospitalization and mortality data will provide this information.

The Cochrane Review states influenza vaccination did not change the number of people needing to go to hospital or taking time off work (7) Yet the influenza vaccine is promoted in workplaces to reduce the amount of time employees take off work.

In Australia the flu vaccine has been offered free to people 65 years and older since 1999. This program has had an uptake rate of 79% (8). The strongest evidence for the effectiveness of this campaign would be an analysis of the hospitalization data and deaths in this age group since the program started ten years ago. This analysis has not been published or presented as evidence in the formulation of current influenza policy (9).

The evidence being used by policy-makers regarding the efficacy of flu vaccine is derived from random controlled trials and observational studies. The Cochrane Review states that many of these studies are of poor methodological quality and are known to be affected by bias and confounding (9). These studies provide inconclusive evidence on vaccine effectiveness leaving the issue open to debate.

A recent Cochrane Review of all the studies conducted on the effectiveness of influenza vaccines in children concluded that inactivated vaccines had low effectiveness in preventing influenza (6). It was stated that the efficacy of inactivated vaccines for children under two was similar to placebo, that is, not effective at all (6). It was concluded that due to the variability in study design an analysis of safety data for influenza vaccines in children was not feasible (6). Inactivated vaccines are the most commonly used vaccines in young children and only one safety study has been done of these vaccines in children under two years of age (6). In addition, there are no long-term health studies that have examined the safety of influenza vaccines when combined with multiple other vaccines in children.

The Cochrane Review of vaccine effectiveness in the elderly population in homes concluded “there was no correlation between vaccine coverage and influenza-like illness attack” (11). It was found that vaccine use in elderly individuals living in the community was not significantly effective against influenza or pneumonia (11).

Much of the evidence obtained in these reviews comes from non-randomized trials which are known to be affected by confounding (10). This is why more weight should be given to the data on hospitalizations and deaths due to influenza. An analysis of this data is the most accurate method of determining whether the campaign is achieving its objectives. Unfortunately this data has not been published or used to support the current influenza policy.

A Canadian study has already examined the influence of flu vaccine on hospitalization and mortality data. This study was conducted in Ontario to determine if the incidence of influenza had decreased following the Introduction of the Universal Influenza Immunisation Campaign in 2000. All laboratory cases diagnosed between 1990 and 2005 were analyzed (12). The conclusion was that despite intensified vaccination distribution and the increased financial resources used to promote vaccination the incidence of influenza had not decreased after the implementation of the National Flu Shot campaign (12). This finding has been ignored in the current influenza policy in Ontario and it is observed to have the highest vaccination rate for flu in all provinces.

Despite significant coverage of the flu vaccine in the Australian community for many years, both in the elderly and in workplaces, 2007 was described as a severe flu season with notifications being 3.4 times the 5 year mean (13). In Western Australia it was described as being the worst flu outbreak in four years (1b)

Conclusion It appears that the desire to use vaccines is the overriding influence in policy formation. Australia’s mortality statistics for children do not support the claim that flu is a serious risk to children. Young children are more at risk of complications to flu than older children but does this equate to a serious risk for children? A decision to use a vaccine in the community must consider the risks inherent in adding an extra vaccine to the childhood schedule as children are already receiving multiple vaccines at a very young age. There is still much debate about the safety of using multiple vaccines in children and for this reason parents must be accurately informed of the need for another vaccine.

This decision must also consider evidence regarding the effectiveness of the vaccine. The Cochrane systematic review of vaccines does not suggest the vaccine is effective in children under two and this is the age group at most risk of complications to flu. In addition, there is no evidence that the vaccination campaign in elderly people has been effective in reducing hospitalization and mortality due to flu as this data has not been published. An analysis of this data is an important way of ensuring that the outcomes of the flu vaccination campaign are being achieved however after ten years of running the program no analysis has been published. In addition, the public should demand that the vaccination status of influenza cases admitted to hospitals be published as this would provide the best evidence that the vaccine is effective.

It appears the Western Australian Government has run a fear campaign in the media to encourage parents to vaccinate their children. This campaign has been run on misinformation and inaccurate representation of the facts to the public. If the purpose of this campaign was to see if vaccinating children reduced the circulation of flu in the community and therefore reduced illness in elderly people then it should have been promoted to the community in this way. This amounts to an experiment on our children.

Parents have a right to make an informed decision about vaccinating their children as this procedure involves a medical intervention for healthy children. If the government is misrepresenting the risk of influenza to children and over stating the benefits of the vaccine to the community - without informing parents of the ingredients of vaccines - this policy could have serious consequences for children’s health. The government must be accountable to the public by presenting transparent immunization policies based upon sound scientific arguments. Coercive immunisation campaigns based on anecdotal evidence are unacceptable. The public is also entitled to know what evidence is being used to assess the safety and effectiveness of vaccines.

Judy Wilyman PhD Candidate Murdoch University

Acknowledgements This paper was presented at the National Health Promotion Conference in Perth in 2009. I would like to acknowledge the support given by Associate Professor Peter Dingle (Murdoch University), Associate Professor Brian Martin (Wollongong University) and all the parents and professionals concerned about the information immunization policies are promoted on.

References 1) a) Government of Western Australia, Department of Health, Media Release 15th February 2008, Free vaccines to help fight child influenza. b) Government of Western Australia, Director of the Department of Health, 2008, Dr. Paul Van Buynder. 2) US Government, Department of Health and Human Services, Centers for disease Control and Prevention, 2008, Prevention and Control of Influenza; Recommendations of the Advisory Committee on Immunisation Practices (ACIP), Morbidity and Mortality Weekly Report (MMWR) 17th July 2008. 3) Western Australian Government, Dept. Health, 2008, Flu vaccination advertisement, The West Australian Newspaper, 6th July 2007. www.public.health.wa.gov.au 4) Australian Government, Australian Institute of Health and Welfare, National Mortality Database, GRIM Book Influenza, 2005. 5) Eldred BE, Dean AJ, McGuire TM, Nash AL, 2006, Vaccine Components and constituents: responding to consumer concerns, Medical Journal of Australia, Vol. 184 Number 4, 20th February 2006. 6) 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. 7) Jefferson T, Rivetti D, Di Pietrantonj C, Rivetti A, Demicheli V, 2008, Vaccines for preventing influenza in healthy adults, Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No: CD001269. 8) Australian Government, Australian Institute of Health and Welfare, 2005, Adult Vaccination Survey October 2004: summary results, AIHW cat. No. PHE 56. Canberra: AIHW & DOHA 9) Australian Government, Department of Health and Ageing, Mortality Team Canberra, 2008. 10) Rivetti A, Jefferson T, Thomas R, Rudin M, Rivetti A, Di Pietrantonj C, Demicheli V, 2008, Vaccines for preventing influenza in the elderly, Cochrane Database of Systematic Reviews 2006, Issue 3. Art No.: CD004876 11) Jefferson T, 2006, Author’s response to influenza vaccination: policy v evidence, The British Medical Journal, Letters; 333:1172 (2 December), doi: 10. 1136/bmj 12) Groll DL, Thompson DJ, 2006, Incidence of Influenza in Ontario following the Universal Influenza Immunisation Campaign, Vaccine, April 5th 2006, PMID: 16624458 13) Australian Government, Department of Health and Ageing, Australian Influenza Report, Report No.13 Week ending 13 October 2007.