Although the efficacy and safety of the discussed vaccines have been widely researched and proven by multiple studies and clinical trials, controversies over vaccines have spanned far and wide for many years throughout both the developed and developing world. These controversies threaten to stagnate or, even worse, reverse the progress made in immunization coverage and decreasing vaccine-preventable disease in children.
Various claims have been made by religious, parent, and even medical groups that not only are vaccines not effective in preventing disease, but they themselves actually cause disease, suffering, and death (International Medical Council on Vaccination, 2011). The ingredients of vaccines have often been called into question and some vaccines have even been blamed for causing disorders such as autism. While the vaccine-autism link has been disproved, many parents in the developed world have refused to have their children vaccinated either on the regular schedule or at all. Expanding immunizations to children in the developing world whose parents are not fully educated on vaccinations may be criticized but fortunately this has not stopped organizations such as GAVI and the Vaccine Fund from continuously providing support to global immunization coverage programs.
A more recent controversy over vaccines in the Muslim world occurred in May of 2011 when the Central Intelligence Agency (CIA) entered Osama bin Laden's Pakistan compound under the guise of a hepatitis vaccination program (New York Times, July 26, 2011). Critics of this operation have raised the concern that this may prevent public health campaigns intended to increase immunization coverage from succeeding in certain countries in the Middle East region. Distrust of Western programs is not uncommon in parts of the developing world, and, as mentioned earlier in this chapter, Muslims in northern Nigeria and northern India refused vaccinations because they believed they were a way for the West to sterilize them. Public health professionals hope the CIA's operation will not impede any future immunization programs in this region or in other regions around the world.
Controversies regarding vaccines are not limited to those in the developing world. In September of 2011 during a nightly news interview, Republican US Representative Michele Bachmann provided an anecdote involving a woman who came up to her and claimed her daughter's mental retardation was a result of her receiving the HPV vaccine. Despite the debunking of this claim by scientists and medical professionals, the harm has already been done in sowing the seeds of fear among many American parents who are staunchly against allowing their daughters to be vaccinated with Gardasil for fear of a severe adverse outcome or the increased promiscuity they believe is involved with a vaccine that prevents a sexually transmitted disease known to cause cervical cancer in women.
Another controversy worth noting is the debate over whether vaccines should be mandated. Texas Governor Rick Perry caused a significant stir when mandating that Texas girls who are eligible receive Gardasil. This mandate, along with school mandates regarding vaccination, have sparked a debate between people who wish to have a choice in deciding whether or not to receive vaccinations and those who believe that being immunized with the vaccines that are currently available for use are not only beneficial to the health of an individual, but to whole communities as well. A good number of schools across the United States allow parents to waive a child's vaccination requirements, usually on religious grounds. This leniency has been blamed for whooping cough and measles outbreaks in cities in the United States in recent years.
HPV Vaccine: When To Start?
The HPV vaccine, Gardasil, while proven to protect against the disease, continues to be controversial due to the nature of the disease. A patient cannot develop cervical cancer unless she has HPV. Therefore, if she does not have HPV, then she will not develop cervical cancer and does not require Gardasil. Some believe that the vaccine will promote sexual activity in teens because it is most effective when administered to girls who are not yet sexually active (Med BIO world, Online, 2006). Some conservative religious groups and abstinence programs are hesitant to support administration of the vaccine because they believe that it may cause "disinhibition” and an "increase in unsafe behaviors in response” (TIME, Online, 2006)
Other ethical issues include how to properly promote the vaccine in the U.S. and elsewhere, and what happens when minors want to determine their own course for sexual health that may be different from their 'sexually conservative parents'' beliefs (TIME, Online, 2006). This will be a growing controversy due to the nature of the vaccine as well as the population that it is supposed to be administered to.
MMR and Autism
Concerns have been raised regarding the link between the MMR vaccine and autism. One reason that many people feel the MMR vaccine causes Autism is because Autism is often noticed around the same time that the MMR vaccine is administered, resulting in people creating a link between the two events (CDC, 2009). This is not the case as both the WHO and the CDC have indicated lack of credible scientific evidence that substantiates the hypothesis that the MMR vaccine causes autism (CDC, 2005; WHO, 2005).
Polio Eradication
In 2003, circulating rumors in the Kano region of northern Nigeria created fear that the polio vaccine would cause HIV or sterility. This mistrust in the safety of the vaccine disrupted the vaccination campaign and led to its immediate suspension. Since mid-2003, polio has spread to 18 countries that had previously been polio-free. In 17 of the countries, the virus spreading is genetically linked to the polio circulating in Nigeria. Since the end of July 2004, the Nigerian government has recommitted to the eradiation effort (Timberg, 2005).
In January 2004, the ministers of health of the six remaining countries where polio is endemic met in Geneva with UNICEF and WHO representatives to launch the final phase of the polio eradication campaign. The implementation of synchronized national immunization days (5 rounds between October 2004 and May 2005) has resulted in a rapid decrease in incidence of polio. Financing and political commitment in these countries remain challenges barring success of eradication (Global Polio Eradication, Online , 2005).
Once global eradication of wild polio virus is achieved, countries now using OPV will have to discontinue in order to eliminate risks associated with vaccine-associated paralytic polio and circulating vaccine-derived polio. With current knowledge about these risks, individual countries can decide on the most appropriate vaccination policies after polio eradication (Heymann, 2004). Below are the latest numbers of Polio cases (Global Polio Eradication, 2009).
BCG's Unreliable Reputation
It is widely recognized that BCG is not very effective at protecting adults against developing pulmonary tuberculosis. However, the WHO promotes BCG for use in infants. Infant vaccinations are believed to reduce the risk of disseminated tuberculosis by 60-90% but are much less effective against pulmonary tuberculosis (Global, 1996). Although the BCG is not extremely effective, the protective effect is long lasting when vaccination occurs in infants (Global, 1996).
Additionally, the weakened bacteria used to make the BCG vaccine have lost a substantial number of genes over time. Research suggests that some of the lost genes and their products may be needed to trigger a protective immune response in vaccinated individuals. BCG strains that have become accustomed to laboratory culture may have lost the ability to maintain a sustained infection in humans; therefore these strains no longer have the requirement necessary for a strong and lasting host immune response to tuberculosis (Young & Robertson, 1999; Behr, 1999).
The Market for Research and Development
Developing countries have the largest burden of disease and the greatest need for vaccines. However, given their limited financial resources, their needs are often of little commercial interest to the pharmaceutical industry. The market fails to generate adequate research and development towards vaccines against neglected diseases. The fact that the market for vaccines against diseases that primarily afflict the developing world is not as profitable as the market for drugs used in the developed world creates perverse incentives for pharmaceutical companies to divert resources. "Future approaches that attempt to enhance practical markets for vaccines and that enhance the introduction of new and underutilized vaccines should consider prioritizing the following: access and equity for as much of the population as is possible, well-implemented accelerated disease-control and prevention strategies, and development of a public-health infrastructure” (Andrus, 2005).
Ethics of Vaccine Programs
Despite the success of immunization programs in protecting people against disease in the last 50 years, ethical issues arise when considering "both the context and implementation of collective immunization programs.” Ethical issues arise relating to the development, introduction, and availability of vaccines. Questions center on prioritizing which vaccines are implemented into national and international vaccine programs and who makes and based on what criteria are these decisions made.
Additionally, ethical issues surround the actual implementation of mass immunization programs and the tension between population perspectives of health versus individual autonomy. These issues beg questions of what means should be used to ensure high vaccination rates and whether compulsory vaccination is warranted. Again, how, based on what, and who makes these decisions are critical questions (Verweij, 2004).
The small pox eradication campaign demonstrates ethical dilemmas surrounding mass immunizations. Undoubtedly, the eradication of smallpox is one of the great public health achievements-- one that has arguably changed the course of history for many nations. However, in the implementation of the campaign, military-like approaches were used and in some communities the health workers were met by refusal. People refused on the basis of fear, religious beliefs, apathy, and fatalism. While smallpox was prioritized by the international community, it was but one issue that troubled the daily lives of many people in resource-poor settings. With vertical programs such as the smallpox campaign, are the healthcare workers obligated to provide for the additional needs of the people they vaccinate? And what is the breadth and depth of this obligation?