There are many ethical issues to consider when introducing a vaccine to a population. The decision is underpinned by the ethical principles of autonomy and beneficence, the former concerning those who are capable of deliberation about their personal goals. These individuals should be treated with respect for their capacity to self-determine. Similarly, those who are vulnerable should be afforded security against harm. The latter, beneficence, concerns ethical obligations to maximise benefits and minimise harm. Harm can only be justified when the aim is for a greater good. In addition, justice, the ethical obligation of solidarity, concerns those who cannot satisfy their basic needs when receiving care. (1) Before the introduction of any immunisation programme, in addition to these principles, the issues of availability and economics, disease burden and prevalence, vaccine efficacy and effectiveness, immunisation schedules and risk: benefit ratios all need consideration. (2) Case study: Was it ethical to introduce the MeNZB™ vaccine to the New Zealand population? Firstly, individual rights (autonomy) need to be balanced with protecting those at risk. This is morally complex as there is an implicit challenge to autonomy, which is expected to create opposition, as has been witnessed in the MeNZB™ campaign. In order to maximise benefit and minimise harm in a public health intervention, opposition is to be expected. If the benefits of the programme outweigh the risks, however, it would be unethical not to proceed with the campaign. The MeNZB™ vaccine was introduced after careful examination of its efficacy, its cost/benefit and risk/benefit ratio and against the backdrop of unacceptable levels of meningococcal B invasive disease. New Zealand's rates of all meningococcal diseases were 14.9 per 100'000 in 2002 prior to the introduction of the vaccine; Australia introduced a vaccine when rates were 3.6 per 100,000. It would have been unethical for New Zealand's Ministy of Health not to introduce a vaccination programme. Another consideration when introducing a new public health intervention is that there is sufficient societal support for those who claim an association between the vaccine and possible side-effects. (1) There were a range of places that members of the New Zealand public could go to get more information about the vaccination programme, including the Ministry of Health, Immunisation Advisory Centre and their local primary care provider. The negligible risk of rare adverse events has been debated openly in the media. Moreover, the datasheet included all adverse events reported during the trials of the Norwegian parent vaccine. This, of course, included the case of one report of chronic fatigue syndrome. This, however, does not imply a causal association. The benefit of having a low probability of getting meningococcal B invasive disease post-vaccination would outweigh the minor risk of getting some of the common side effect and occasionally, rare adverse events. The probability of getting the disease is greater than getting an adverse event. It is important not to give the wrong significance to the probable impossibility of attaining complete certainty about immunisation. (2) Rather, it is more useful to consider the climate for introducing a vaccine and the overall benefits of this introduction to the population. 1. Krantz, I., L. Sachs, et al. (2004). "Ethics and vaccination." Scandinavian Journal of Public Health 32(3): 172-8. 2. Ulmer, J. B. and M. A. Liu (2002). "Ethical issues for vaccines and immunization." Nature Reviews: Immunology 2(4): 291-6. 3. Dare, T. (1998). "Mass immunisation programmes: some philosophical issues." Bioethics 12(2): 125-49. |