Section I 1

Section I

1.1. Introduction

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Throughout the life time, human body is under relentless attack by hordes of living organisms that compete for survival in our environment. The air we breathe, the food we eat, the ground we walk on, the water we drink, the building we live in, the vegetation that surrounds us in general all harbor infectious organisms. These agents of infectious disease come in all shapes and sizes, from microscopic viruses, bacteria and protozoan to foot-long parasitic worms. While these germs may vary wildly in appearance, they all share a dependence on human beings for at least part of their life cycle. They enter the body by hitching a ride in contaminated food or beverages, or by invading the genital tract or the eyes. They may attack even before birth, passing thorough the mother’s placenta where they attack the developing cells of the fetus so that the body may be diseased or deformed at birth (Carol Turkington and Bonnie Ashby, 1998).

Luckily, the human body is not defenseless against this every present danger. Because the human environment is biologically hostile, out bodies have developed delicately sensitive methods that react quickly in the presence of infectious organisms. The skin and the immune system are the body’s primary methods of preventing infection and when intact they can protect admirably well. But, when these barriers break down or are affected by another disease, the body becomes vulnerable to invasion by a frightening array of microorganisms both mild and deadly (Carol Turkington and Bonnie Ashby, 1998).

Vaccines have proven to be an extremely effective way to prevent morbidity and mortality associated with infectious disease. CDC epidemiological surveillance demonstrates up to 99 to 100 percent reductions in several life-threatening infectious diseases in the U.S. Basically, the development and use of newer vaccine technology helps us to fight against infectious diseases that had been previously difficult to vaccinate against. Since, new strains are constantly

emerging the ability to update vaccines is ideally suited to meet the challenges of infectious diseases (Pfizer Value of Medicines, 2014).

Section II

2.1. The value of vaccinations for diseases prevention

Vaccinations are an essential tool for fighting against infectious disease. According to the World Health Organization (WHO), vaccination has greatly reduced the burden of infectious disease globally (United States Fund for UNICEF, n.d.). Vaccines protect the vaccinated individual by direct immunization and can protect unvaccinated individuals through community protection or herd immunity. It has also been highlighted as one of the main reasons for the fall in health disparities both within and across countries in the last century. It was recently estimated that since 1924, vaccinations have prevented 103 million cases of childhood infection, representing approximately 95 percent of infections that would have occurred, including 26 million in the last decade alone (Van Panhuis, et al., 2013 and Andre, et al., 2008).

Obviously, today, vaccines and infectious disease treatments have proven to be effective treatments in many cases, but infectious diseases still pose a very serious threat to patients. Recently, some infectious pathogens, such as pseudomonas bacteria, have become resistant to available treatments. For instance, America’s biopharmaceutical research companies are developing 394 medicines and vaccines, up to 2013, to combat many threats posed by infectious diseases. Among the medicines and vaccines in development, 226 of them are for viral infections, such as hepatitis, herpes and human papilloma virus (HPV);
124 for bacterial infections, such as pneumonia and tuberculosis; 24 for fungal infections and 15 for parasitic infections. Some of potential medicines for fighting infectious diseases include:

? A combination treatment for the most common and difficult to treat form of hepatitis C that inhibits the enzyme essential for viral replication.

? An anti-malarial drug that has shown activity against Plasmodium falciparum malaria which is resistant to current treatments.

? A potential new antibiotic to treat methicillin-resistant Staphylococcus aureus (MRSA).

? A novel treatment that works by blocking the ability of the smallpox virus to spread to other cells, thus preventing it from causing disease (America’s Biopharmaceutical Research Companies, 2013).

2.2. Ethical, legal and political aspects of vaccination against infectious diseases
2.2.1. Ethical aspect

Over the past two decades, much activity has been directed toward the goal of defining the ethical principles relevant to public health. There is some consensus, as put forth by Childress et al. in 2002 (as cited by Alvin Nelson et al., 2012) that the most relevant of these principles, which they label moral considerations, are:
1. producing benefits;

2. avoiding, preventing, and removing harms;

3. producing the maximal balance of benefits over harms and other costs

(i.e., utility);

4. distributing benefits and burdens fairly (distributive justice) and ensuring public participation, including the participation of affected parties (procedural justice);
5. respecting autonomous choices and actions, including liberty of action;

6. protecting privacy and confidentiality;

7. keeping promises and commitments;

8. disclosing information as well as speaking honestly and truthfully (i.e., transparency); and
9. building and maintaining trust.

According to Childress et al. (2002) suggestion, three of these moral considerations (benefiting others, preventing and removing harms and utility) are

critical to the goal of public health while three others (justice, respect for autonomy, and privacy) are most likely to limit public health activities (Alvin Nelson et al., 2012).
In addition to defining the ethical issues relevant to public health, we must also acknowledge that there are often instances in the practice of public health decision making and program implementation where the above noted considerations may come into conflict, provoking a need to choose or assign a greater weight to one of these moral considerations over another. Childress et al. (2002) proposed five “justificatory conditions” to help determine when the moral considerations critical to public health (benefiting others, preventing and removing harms, and utility) can take precedence over the other goals during specific public health activities. These “conditions” are: effectiveness of the activity, proportionality of the activity (the probable public health benefits outweigh the “infringed” other moral considerations), necessity of the activity, the extent to which the activity represents the least infringement of the other moral considerations, and lastly, the ability to publicly justify the activity in a transparent manner. Because, vaccination activities are a key component of many public health programs that fall within this ethical framework (Alvin Nelson et al., 2012). Diekema and Marcuse (2007) however, have put forth a direct approach for evaluating and resolving ethical issues around mandatory vaccination programs. Their approach is based upon the often cited medical maxim commonly translated as: “first, does no harm.” When applied to vaccination activities, this maxim has the following implications: the vaccination should be of benefit to the subject being vaccinated; care should be taken to prevent any harm that might accrue from the vaccination; compared to other procedures for addressing the same issue, the vaccination should be the best opportunity for successfully preventing disease as compared to the risk for harm; and if harm does result from the vaccination, the benefit of vaccination to the subject should at least compensate for the harm brought upon the vaccinated person.

Because, vaccination provides not only a direct benefit (immunity to disease) to the person being vaccinated but also provides a benefit to others in the community via herd immunity, Diekema and Marcuse (2007) remind us that unvaccinated persons can be viewed as “harming” the community. It, therefore, follows that for serious and highly communicable diseases, there is a role for compulsory vaccination programs. They also cite the utilitarian philosopher John Stuart Mill who held that: “The only purpose for which power can rightfully be exercised over any member of a civilized community, against his/her will, is to prevent harm to others. His/her own good, either physical or moral, is not sufficient warrant.” This principle, known as the “harm principle,” can be used to expand the application of the maxim: “first, do no harm” to the community interests that result from vaccination programs. It, therefore, follows that the “harm principle” can be used to justify compulsory vaccination programs in specific instances where the community interests or benefits are deemed to be significant. Often, the issue is in determining what is considered significant. Finally, the “precautionary principle” has been put forth by Gostin et al. (2003) as being critical in public health’s response to potential infectious disease emergencies. This principle was initially defined as being relevant to environmental health emergencies and asserts that public health is obligated “…to protect populations against reasonably foreseeable threats, even under conditions of uncertainty… Given the potential costs of inaction, it is the failure to implement preventive measures that requires justification…”

2.2.2. Legal aspect

Vaccines are safe and effective; they are neither perfectly safe nor perfectly effective. Some persons who receive vaccines will have an adverse reaction, and some will not be protected. In developing vaccines, the challenge is to minimize the likelihood of adverse effect while maximizing effectiveness. Some people have medical conditions that increase the risk for adverse effect, and therefore they should not receive vaccines. Recognizing this fact, all state vaccination laws

provide for exemptions for persons with contraindicating conditions (Kevin M. and

Alan R., n.d).

The responsibility of the government to protect the public from the dangers of highly communicable and deadly diseases like smallpox was clearly established in the Supreme Court’s 1905. However, this responsibility existed long before the vaccine related court ruling and was historically implemented through the “police powers” of the local health officer for many functions such as sanitation and food safety, as well as during times of extreme public health emergencies. The police powers of the local health officer derive from the inherent powers of state governments to provide for, and protect, the public’s health (Alvin Nelson et al.,
2012).

The decision whether or not to vaccinate is an important one. No matter where you stand on the issue, there are undeniably risks involved on both sides: on one side, the risk of your child contracting a disease if you decide not to vaccinate; on the other side is the risk of injury or death if you do vaccinate. The crux of the matter is of course the likelihood of such a tragedy, which is subject to debate. What cannot be debated is that your right as a parent not to vaccinate your child if you so choose are not widely known, and exercising such rights is not encouraged. Furthermore, the remedies available to those whose children have suffered injury or death from vaccines are limited by law, are expensive and time consuming to obtain, and are generally unknown to the public. Only when people know their rights can they make an informed choice this is a fundamental tenet of a free society. Therefore, it is essential to those concerned about the vaccination decision to know what the law provides (GVAL, n.d).

A majority of states have enacted into law some kind of exemption from mandatory childhood vaccinations, based either upon personal or religious belief or for medical reasons. For instance in California, state law provides for mandatory vaccinations for diphtheria, hepatitis, influenza, measles, mumps, pertussis, poliomyelitis, rubella and tetanus, and any other diseases designated by the Department of Health Services in consultation with the Center for Disease

Control and the American Academy of Pediatrics. This requirement is waived if the person “files with the governing authority a letter or affidavit stating that the immunization is contrary to his or her beliefs.” If the exemption is exercised, the student may be temporarily excluded from school if “there is good cause to believe that the person has been exposed” to one of the enumerated diseases “until the local health officer is satisfied that the person is no longer at risk of developing the disease.” In that regard each student in California is required to submit a “California School Immunization Record” to be admitted to school (GVAL, n.d).

There is another exemption which is available, although it is more difficult to exercise because a medical opinion is necessary. If immunization is “contraindicated”, that is, considered to be potentially harmful to the child for medical reasons, an exemption is granted upon the filing with of “a written statement by a licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature and probable duration of the medical condition or circumstances that contraindicate immunization…”(GVAL, n.d). Basically, all as such kinds of reasonable regulations established directly by legislative enactment will protect the public health and safety.

Some countries state their legal requirements for travelers those want to enter in their countries. For instance Bahrain required for all travelers those coming from
polio?endemic countries must have proof of polio vaccination. Likewise, India
requested oral polio vaccination at least four weeks before departure for resident

national travelers from polio endemic countries such as Afghanistan, Nigeria and Pakistan with poliovirus circulation following importation like Ethiopia, Kenya, Somalia, Syrian and Arab Republic. Qatar requested International certificate of polio vaccination as per the International health Regulations for all travelers
arriving from polio?exporting countries. And Saudi Arabia inquired for umrah and

hajj pilgrims regardless of age and vaccination status, proof of receipt of a dose of oral polio vaccine (OPV) or inactivated vaccine (IPV), within the previous 12 months and at least four weeks before departure, is required for travelers arriving
from polio?endemic countries to apply for entry visa (International travel and
health page of the WHO, 2015).

2.2.3. Political aspect

Immunization has provoked popular resistance, often due to apprehensions about adverse effects in healthy children. Senator Paul referred to “many tragic cases of walking, talking, normal children who wound up with profound mental disorders after vaccines.” A 1998 report, since retracted as fraudulent, suggested a link between MMR vaccine and autism. Even though, numerous studies and independent reviews of data have found no relationship between MMR vaccine and autism, concerns linger (Lawrence O., 2015).

Parents express a wide spectrum of concerns, including the right to raise their children, give informed consent, and the freedom of religion or conscience. A small fraction of parents categorically oppose vaccinations, but many others are concerned primarily with state mandates. For these parents, a “nudge” may be all that is required, such as being informed of the science and making exemptions for immunizations more difficult to obtain. The uptake of vaccines, moreover, is associated with perceived susceptibility to and severity of childhood diseases. The catch-22 is that because vaccines are such powerful tools of prevention, individuals are less inclined to vaccinate their children because they rarely see vaccine preventable childhood diseases (Lawrence O., 2015).
Moreover, history informs valid concerns regarding bioterrorism. It is clear that States, lone individuals, and political/terrorist groups have and mean to acquire and use biologic weapons in order to achieve a variety of political ends. In addition, widespread population susceptibility to these agents exists; placing the sustainability of nations at risk should a widespread bioterrorism event occur. For

instance, in 2001, within the United States 22 cases of inhalational anthrax resulted from weapons-grade anthrax powder sent through the US postal system, resulting in 5 deaths. These attacks resulted in disruption of the postal system, the Senate and Senate buildings, airlines, and multiple other entities important to national economy and political life. Therefore, political concerns play an important decision-making role in both the decision to develop and the decision to use bio-defense vaccines. Due to the sizeable time and monetary costs incurred, embarking on a vaccine development program must be informed by evidence of a credible threat. The decision by one country to develop a vaccine against a bio-agent implies knowledge that another country has weaponized such an agent and has the intent, will, and means to use the agent as a bio-weapon. The sudden resumption of use of smallpox vaccine among one nation’s military, prompts concern and use in other countries. Politically this sends an important message to neighboring or other nations. Within domestic politics concerns also exist. The development of new vaccines is expensive, and funding such a program means diverting funds from other needs. This complicates decision-making and introduces a variety of considerations difficult to reconcile among the public (Gregory A, 2010).

2.3. Conclusion

Ethical, legal and political aspects of vaccination have been key factors in the prevention and control of vaccine-preventable diseases in all over the world. Specifically, ethical issues pertaining to vaccination activities are very crucial in the implementation of and the public’s response to vaccination programs. Often, some ethical principles are contradicted with others; and some are required to be given more weight than others, when mandatory vaccination campaigns are implemented. Of course, efforts have to minimize conflicts among the relevant ethical principles, because, such conflicts can feed anti-vaccination movements.

Obviously, usually the program of vaccination exempted and interference by some religious and wrong philosophic ideologists. So, it should be supported by

legal law. In fact, no constitutional right exists to either a religious or philosophic exemption to these requirements, although most states allow religious exemptions and several allow philosophic exemptions. The courts have generally upheld these exemptions.

Likewise, the political aspect of vaccination should get a better consideration for controlling not as weaponized agent. Factually, political concerns play an imperative role in both the decision making for development and the decision to use bio-defense vaccines.

References

• Carol Turkington and Bonnie Ashby, 1998, Encyclopedia of Infectious

Diseases, Printed in the United State of America, New York.

• America’s Biopharmaceutical Research Companies, 2013, Medicines in Development: Infectious Diseases, A Report on Diseases Caused by Bacteria, Viruses, Fungi and Parasites, USA.

• United States Fund for UNICEF, n.d, Immunization for All Children: Think BIG, http://www.unicefusa.org/work/immunization/?gclid=CJbxlOK0mr0CFbBj7
Aod0noAcg

• Andre, et al., 2008, Vaccination Greatly Reduces Disease, Disability, Death and Inequity Worldwide,
http://www.who.int/bulletin/volumes/86/2/07-040089/en/

• Van Panhuis, et al., 2013, Contagious Disease in the United States from

1888 to the Present, New England Journal of Medicine, Britain.

• Pfizer Value of Medicines, 2014, The Value of Vaccines in Disease Prevention, https://www.pfizer.com/files/health/VOMPaper_Vaccines_R7.pdf
• Alvin Nelson, Michelle T., Robert Kim-Farley, Jonathan E., 2012, Ethical Issues Concerning Vaccination Requirements, Los Angeles County Department of Public Health, Los Angeles, USA.

• Diekema DS, Marcuse EK, 2007, Ethical issues in the vaccination of children, Public Health Ethics: Theory, Policy and Practice, Oxford University Press, New York.

• Gostin LO, Bayer R, Fairchild AL, 2003, Ethical and legal challenges posed by severe acute respiratory syndrome: implications for the control of severe infectious disease threats, JAMA (V. 290:No. 3229-37), USA.
• Gval, n.d., Legal Aspects of Vaccinations: Waivers and Compensation, http://www.gval.com/legal.htm.

• International travel and health page of the WHO, 2015, State country requirements ITH 2015 edition, http://www.who.int/ith/en /.
• Lawrence O., 2015, Law, Ethics, and Public Health in the Vaccination Debates: Politics of the Measles Outbreak, Georgetown University Law Center, Georgetown, Malaysia.
• Kevin M. and Alan R., n.d, Vaccination Mandates: The Public Health Imperative and Individual Rights, http://www.cdc.gov/vaccines/imz- managers/guides pubs/downloads/vacc_mandates_chptr13.pdf
• Gregory A., Robert M. J, Jon Tilburt and Kristin Nichol, 2010, The social, political, ethical, and economic aspects of bio-defense vaccines, U.S. National Library of Medicine, Rockville Pike, USA.

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