The Ethics of Childhood Influenza Immunization

The Western Australian Government began a campaign in 2008 to promote the influenza vaccine free to children 6 months to 5 years of age. A decision to include another vaccine on the childhood immunization schedule should be based upon accurate scientific knowledge not a fear campaign. This paper investigates the evidence being used to promote this vaccine. It also examines the ethics of adding another vaccine to the already full childhood schedule and the information this decision is based upon. This research examines the Cochrane Systematic Review of influenza vaccines and whether the evidence from this study is being used to develop immunization policies. This study finds that influenza is not a serious risk for most children. It also finds evidence that inactivated flu vaccine is ineffective in children under 2 years of age – the age of most complications. The overwhelming evidence indicates it is inappropriate and unethical to add another vaccine to the childhood schedule if the majority of children are not at serious risk from this disease and if the vaccine is not proven to be effective.

SHOULD AUSTRALIAN CHILDREN BE IMMUNIZED?

by

Judy Wilyman

Introduction

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 influenza and to assess the efficacy of the vaccine in preventing influenza in the community (1a).

It appears 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 Centre for Disease Control’s Advisory Committee on Immunization Practices (ACIP, America) 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). 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. The WA Health Department promoted free childhood influenza vaccines 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 (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 at the time (1b). The Director of the flu campaign, Dr. Paul Van Buynder stated the information on these deaths was restricted to the public yet the information was used in a state based media campaign (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 confirmed with Influenza A as opposed to all three children that the vaccine advertisement had implied (3).

Methods

The scientific evidence which illustrates the risk of influenza to children is the mortality and morbidity rates in the 0-5 year age group for previous decades. Records of this data were obtained from the WA Health Department. This data was compared with the national data to see if the trend was similar across Australia. Information on the reason for including influenza on the childhood schedule was obtained from the National Centre for Immunization Research and Surveillance as well as the WA Health Department. Data on the effectiveness of children’s influenza vaccine was obtained from the Cochrane Systematic Review of Vaccines.

Our knowledge of the effects of vaccines has now been collected for over 100 years. It is important to look at the ecological health of the population as well as the statistics collected over this time to ensure this procedure is safe. This is because statistics can hide many variables. The ecological evidence is showing that the health of children has not improved as the number of vaccines on the childhood schedule has increased (4). To suggest that this is a coincidence is unscientific. Children’s health and the health of society are dependent upon scientifically proven preventative policies. If it is biologically plausible that the ingredients of vaccines can cause the increase in chronic illness we are observing in children then this possibility must be investigated. The increase in autoimmune diseases in dogs and cats has already been linked to vaccines and we must consider this same possibility in children (5).
In determining the effects of combining vaccines in children it is also important to recognize that there are gaps in our scientific knowledge regarding human immunology. For this reason many of our decisions regarding this practice have become value judgments and this paper discusses the ethics of how these value judgments are being made in place of scientific debate and information.

Results

An investigation of the mortality data for influenza indicates that the number of deaths for children under 5 years of age in Western Australia is between 0 – 3 deaths per year (6). This has been the number of deaths for the last 4 decades and is similar to all other Australian states (6). National deaths from influenza in children under 5 have been between 0-3 since 1977 (6). These statistics do not justify the general vaccination of children for influenza (7).

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 (8). 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 (6).

The assessment of the risk of this disease should also include the morbidity from complications of influenza and an assessment of the social circumstances surrounding cases of influenza.

Social conditions should be assessed with cases of this disease because infectious diseases are associated with poor living standards and other social factors such as nutrition (9). Currently this data is not reported (1e). It should also be noted that a decision to vaccinate all children for influenza should not be based upon data from other countries as local factors such as living conditions, nutrition, available healthcare and patterns of childcare will affect the benefits of using the vaccine (7). The excess rates of influenza-related hospitalization vary substantially by age, season and country (7). Yet the Western Australian Health Department has based its childhood influenza campaign on data from other countries (1b).
It is observed that the attack rates for influenza are consistently high in children during annual outbreaks (7). However, even when the attack rates are 20-30% it is known that the majority of these children make a full recovery and discomfort is the main symptom of illness (7). It is known that epidemics of influenza are “generally very mild” (7, p.225)

A recent survey of US pediatricians illustrated that 43% actively opposed the universal vaccination of children and 27% were unsure (7). This would not be the case if health professionals considered influenza to be a serious risk to children. These are front line health professionals who observe the risk of this disease on a daily basis. In addition, 50% of pediatricians were concerned about the safety of the inactivated vaccine (7).
Bacterial illnesses such as acute otitis media, croup, bronchitis, pneumonia and other respiratory diseases such as asthma are considered complications of influenza. These are described as influenza-associated hospitalizations and are highest in children younger than 3 years of age (7). Most children with influenza-associated conditions are not hospitalized and it is observed that infants and young children with underlying medical problems are at highest risk of being hospitalized (7). The highest risk of influenza-associated hospitalization is in infants under 6 months of age yet the inactivated influenza vaccine is only licensed for use in children 6 months and over (7).

The Australian mortality data for influenza and a survey of doctors indicates that this disease is a very low risk for children. In addition, Heikkinen et al (2006) state “influenza-associated mortality in children is extremely low” (p.224). 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 (1c). The combination of many vaccines must be considered when weighing up the risks of diseases as vaccines contain antibiotics, preservatives and aluminium adjuvants that are known allergens and neurotoxins (10). The cumulative and synergistic effects of the increased number of vaccines must be considered. It is also necessary to determine how effective the vaccine is in preventing influenza in the community.

Safety and Efficacy of Influenza Vaccine

Influenza is a disease that is caused by many strains of virus, however the vaccine only protects against one to three strains depending on the type of vaccine used (1d). The government uses two definitions to describe the effectiveness of the vaccine. The term efficacy is used to describe how well the vaccine protects against the 3 strains of influenza covered by the vaccine. For example the current vaccine protects against Type A (H1N1), Type A (H3N2) and Type B (1d). The term effectiveness of the vaccine is used to describe the ability of the vaccine to protect against ‘influenza-like illness’ (ILI), that is, all influenza that is not laboratory confirmed and the strain of virus is unknown (1d).

Therefore, some ILI will be caused by strains of virus that are present in the vaccine so the only real indicator of whether vaccine programs are reducing the incidence of influenza in the community is to monitor the hospitalizations due to all influenza-like illness each year – not just the cases caused by influenza strains covered by the vaccine. At present the WA government is reporting on hospitalizations caused only by the strains covered in the vaccine to support its policy (1e).

Influenza viruses spread easily and new strains develop regularly (11).The World Health Organization (WHO) recommends the strains that should be included in the vaccine for each new season (11). 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 (11). But the government must still provide evidence to the public that a well matched vaccine will reduce the incidence of influenza-associated illness in the community. It is possible that because there are many viruses causing influenza illness in the community reducing the circulation of 2 or 3 will not reduce the incidence of these diseases as other species are able to infect.

This is another reason why it is important to analyze hospitalization and mortality data to ensure this program is achieving its outcomes. An assessment of this data will confirm whether predicting the most severe strain of influenza virus a year in advance is a successful strategy.

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% (6b). 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 (12).

A recent Cochrane Review of all the studies conducted on the effectiveness of influenza vaccines in children stated that the efficacy of inactivated vaccines for children under two (against strains contained in the vaccine) was similar to placebo, that is, not effective at all (8). It should also be noted that the Cochrane Review states that neither type of influenza vaccine – inactivated or weakened influenza viruses (nasal sprays) were good at preventing ILI in children over 2 (8). This is significant because an unknown proportion of ILI will be caused by the influenza strains covered in the vaccine. Whilst Heikkinen et al (2006) claim the average efficacy of inactivated vaccines in children is 70-80% they admit that effectiveness in the community is substantially reduced against influenza-like illness (7).

It was also concluded in the Cochrane Review that due to the variability in study design an analysis of safety data for influenza vaccines in children was not feasible (8). 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 (8). Heikkinen et al, 2006, claim the vaccine to be “safe and effective” but do not support this statement with evidence (7, p.224). 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 (12). In other words, our scientific knowledge on this issue is incomplete.

Despite significant coverage of the influenza 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 (3). This evidence is not an indication that influenza vaccine is reducing the incidence of this disease in the community.

Although notifications for this disease are highest in the 0-4 year age group this is not a reflection of the severity of the disease in the population. This is because influenza is only considered a serious disease in the elderly and immune compromised and the majority of individuals make a complete recovery after several days (7,14, 9).

Conclusion

Influenza has been promoted to the public in WA as a serious risk to children even though the influenza-associated mortality for children is described as very low. The children at highest risk from influenza are children under 6 months of age and the vaccine is not licensed for this age group. In addition, the inactivated flu vaccine has been described as ineffective for children under 2 and this is the group with the highest complications to flu. The other reason for vaccinating children is to see if it lowers the transmission of influenza in the community.
Statistics can hide many variables so it is important that the public is presented with information that best represents the incidence of influenza in the community.

If the government monitors only the cases of influenza covered by the strains of virus in the vaccine it cannot ignore ILI cases, as a percentage of these will be caused by strains of virus covered in the vaccine. Therefore, evidence for the effectiveness of influenza campaigns can only be determined if the government presents hospitalization data for all influenza-like illness. This will inform us whether the theory of selecting for 2 or 3 strains of influenza virus in the vaccine is effective in reducing the incidence of this disease in the community. It is possible that targeting 2 or 3 species only allows a space for one of the many other influenza viruses to cause infections. In this case there will be no reduction in hospitalizations to influenza-associated illness.

A decision to use another vaccine in children for the benefit of the community must be based on accurate scientific evidence. It must also consider the risks inherent in adding an extra vaccine to the already crowded childhood schedule.

Other evidence that should be used in the risk analysis of disease is the ecological evidence in the population. It is important to observe overall trends in health when it is known that statistics can hide many variables. In the case of influenza campaigns and children’s health, there are two ecological trends that are being observed: 1) communities are still experiencing severe outbreaks of influenza despite vaccination campaigns in the elderly and in workplaces 2) children’s health has declined as the use of vaccines has increased.

Risk analysis is not wholly scientific in nature and value judgments are made when the science is absent. In the case of childhood immunization there are no long-term studies of the health effects of combining 12 vaccines in an infant. This gap in our scientific knowledge of the cumulative and synergistic effects of vaccines in infants leads to disagreement on the risk involved and therefore different parties will make different value judgments regarding this risk.

A decision to use influenza vaccine must also consider evidence regarding the effectiveness of the vaccine. The Cochrane systematic review of vaccines does not suggest this vaccine is effective in children – particularly those under two. An analysis of hospitalisation data is an important way of ensuring that the outcomes of the influenza vaccination campaigns are being achieved.

The evidence suggests the Western Australian Government has run a fear campaign in the media, based on misinformation and anecdotal evidence, to encourage parents to vaccinate their 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 this policy could have serious consequences for children’s health and society. It also undermines the independent nature and credibility of the government.
Vaccines are not without risk so it is important that value judgments about the necessity for a vaccine are made from non-biased sources. The government must therefore be seen to be openly informing parents on this issue. It is also essential that governments consider the possibility that multiple vaccines in infants are doing more harm than good particularly as this link has been described in veterinary journals and it is known that individuals can be genetically pre-disposed to chronic illness.

This research has implications for the use of mandatory and coercive immunization policies. At present government welfare benefits, school entry and doctors salaries are linked to childhood immunization policies in Australia. Although immunisation in Australia is not compulsory parents believe that it is because it is tied to the above entitlements. Until the science on this issue is complete it is important that immunization policies remain fully discretionary as they are in Europe and that governments are selective about the vaccines included on the recommended schedule.

Judy Wilyman
PhD Candidate, Murdoch University

Acknowledgements

I would like to acknowledge the encouragement and support of Associate Professor Peter Dingle (Murdoch University) and Associate Professor Brian Martin (Wollongong University) in writing this article. I would also like to mention all the parents, health professionals and doctors who have encouraged me to continue with this research and who are requesting that immunization remains a discretionary policy.

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(Author has been asked to number references according to text.)

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