Ethical Issues and Vaccines

Centers for Disease Control and Prevention
The Vaccine Information Sheet for a vaccine against human papillomavirus
 
National Library of Medicine
Compulsory vaccination in New Jersey in the 1880s
 
The Historical Medical Library of The College of Physicians of Philadelphia
This photograph from a brochure shows the cattle operating room at Dr. H.M. Alexander's vaccine farm, outside Philadelphia.
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Vaccines are responsible for many global public health successes, such as the eradication of smallpox and significant reductions in other serious infections like polio and measles. Even so, vaccinations have also long been the subject of various ethical controversies. The key ethical debates related to vaccine regulation, development, and use generally revolve around (1) mandates, (2) research and testing, (3) informed consent, and (4) access disparities.

U.S. Vaccine Mandates and Objections

In the United States, state policies mandate certain immunizations, including school entry requirements, which cover significant numbers of children.[1] The first school vaccination requirements were enacted in the 1850s to prevent smallpox.[2] Federal and state efforts to eradicate measles in the 1960s and 1970s motivated many modern mandates policies.[3] By the 1990s, all 50 states required students to receive certain immunizations, and most states required coverage for older schoolchildren and those in daycare centers and Head Start programs.[4], [5] Vaccines are licensed and added to the immunization schedule after careful research, testing, and monitoring, which is coordinated and reviewed by The National Vaccine Program and other key vaccine committees, like the Advisory Committee on Immunization Practices (ACIP).[1] States then devise mandates according to this body of knowledge.

Ethical debates and objections to school and other mandates arise because some individuals and communities disagree with the mandates, and/or have religious or philosophical beliefs that conflict with vaccination.[1] For example, in an effort to protect the greatest number of people, public health vaccine regulations may infringe upon individual autonomy and liberty.[6] Tension results when individuals want to exercise their right to protect themselves and/or their children by refusing vaccination, if they do not accept existing medical or safety evidence, or if their ideological beliefs do not support vaccination.[6]

Sometimes vaccine mandate controversies include multiple and interrelated ethical dilemmas. This is the case for the vaccine for the human papillomavirus (HPV), a sexually transmitted disease (STD). The FDA approved the first HPV vaccine in 2006. After the ACIP recommended three doses of the vaccine for girls aged 11-12, various state legislatures attempted to mandate vaccination. Ethical objections to this mandate have ranged to include religious concerns that a vaccine to protect against an STD contradicts abstinence-based messages; fears that the vaccine could potentially force a child to undergo an intervention misaligned with her family’s beliefs; and human rights questions about the fairness of providing a vaccine to one sex only (though now in the United States the vaccine is recommended for all adolescents).[7], [8]

To respect individuals’ beliefs and address their varied concerns, all 50 states allow vaccination exemptions for medical contraindications; 48 states allow religious exemptions; and 20 states allow exemptions for philosophical reasons.[4] Many scientific and medical research studies have found that individuals who exercise religious and/or philosophical exemptions are at a greater risk of contracting infections, which put themselves and their communities at risk.[9] Thus, medical and public health advocates often struggle to balance the ethics of protecting individual beliefs and the community’s health.[6]

Vaccine Research and Testing

Ethical discussions also surround the research and testing of vaccines, including discussions about vaccine development, and study design, population, and trial location.

To be licensed, vaccines go through many years of research, and must pass rigorous safety and efficacy standards.[1] The vaccine development and research process includes diverse experts many scientific and social disciplines, including public health, epidemiology, immunology, and statistics, and from pharmaceutical companies. These stakeholders may have conflicting priorities and motives, which contributes to various ethical discussions.[10]

Sometimes researchers disagree about whom to include in vaccine trials. To properly test a vaccine’s effectiveness, a clinical trial including a control group that does not get the test vaccine is usually necessary.[1] Failing to provide any adequate preventive option can be a difficult decision when the vaccine can potentially prevent a serious, untreatable, or fatal infection, however. For instance, TB vaccine researchers have struggled to devise ethical control group procedures. Existing TB vaccines, called Bacillus Calmette-Guérin (BCG) vaccines, are not always effective to prevent TB, and can cause infections in people with compromised immune systems, such as people living with HIV/AIDS. When they test the effectiveness of new strategies, researchers debate over whether or not it is safe and ethical to give control participants these vaccines.[11] 

Additionally, it is important to understand a vaccine’s safety and efficacy in various populations, but testing a vaccine in vulnerable populations, such as children, also raises ethical concerns.[12] Researchers must balance the need to protect children’s safety with the need to adequately understand how a vaccine will perform and protect children when administered.

Similarly, it is important to understand how vaccines affect people in developing countries. Yet, conducting vaccine research in developing countries includes a list of ethical concerns such as how to provide necessary screening or treatment if diseases are detected; how to meaningfully involve local communities in the research design process; how to ensure the trial and vaccine can be supervised by local ethical review panels; and how to ensure that participants understand consent.[11] For example, participants in a malaria vaccine trial in Mali reported difficulty understanding several concepts including withdrawal from study, side effects from the vaccine, and the difference between a research study and therapy,[13] suggesting that better communication strategies are required to ensure proper consent across cultures.

Ethical discussions are a key component of HIV vaccine research and development because HIV vaccines pose numerous unique ethical challenges. For example, AIDS stigma may put vaccine trial participants at psychological risk if they encounter discrimination. In addition, researchers have to figure out how to provide appropriate and adequate medical care and protection from stigma for participants who screen HIV positive. And, researchers have to consider that if participants misunderstand the trial, they may think that they are protected from the virus and put themselves at risk.[1], [10], [14-15] The complexity of these issues places ethics analyses at the forefront of HIV vaccine research. 

Informed Consent

Ethical debates also surround vaccine implementation and delivery, such as those concerning informed consent.[10] Although federal guidelines do not require consent before vaccination, the National Childhood Vaccine Injury Act of 1986 requires that doctors give vaccine recipients, or their parents or legal representatives, a Vaccine Information Statement (VIS). The VIS provides basic information about vaccine risks and benefits and is designed to provide the information a patient or parent needs to make an informeddecision.[16]

Some states have specific informed consent laws.[16] Certain lawmakers and other patient rights advocates believe that consent is ethical and appropriate, so that parents are better informed about vaccines, and have adequate time to ask questions if needed. Opponents fear that consents may add unnecessary fear or concern to the vaccination process.[17]

Access Issues

Many vaccine-related ethical debates center on the evidence that access to vaccination depends to some extent on socioeconomic and racial ethnic minority status. Implicit in these discussions is the question of whether or not all lives are of equal value, and equally deserving of opportunities to be protected by vaccination.[1]

Several vaccine shortages have made headlines over the last 10 years. Between November 2000 and May 2003, the United States saw shortages of 8 of the 11 vaccines for childhood diseases. And in 2004, the flu vaccine shortage grabbed national media attention.[18] Shortages result from too few vaccine producers and suppliers.[1], [18] Various factors limit vaccine research and development, including liability, expense, time, and decreased demand. For example, demand for flu vaccine varies annually, and producers must dispose of extra vaccine each year.[18] From an ethical perspective, increasing the number of vaccine producers would greatly influence health positively. When vaccines are in short supply, medical providers must make decisions about who should be protected, and who must be left vulnerable to disease.[10]

In the United States, low-income children and children without health insurance can face challenges to receiving vaccinations. The Section 317 program,[19] a federal program to vaccinate underserved children, attempts to help support coverage, but cannot serve all children in need.[10] Access disparities also affect adults. Even after controlling for economic status, researchers have found that racial ethnic minority adults are less likely than whites to receive preventive care including vaccination.[20]

Global health disparities are even more extreme and highlight additional ethical dilemmas. Developing countries face threats from disabling and deadly infections, called “poverty diseases,” such as hookworm and leprosy, which are unknown to most Americans. Although vaccines can help prevent these diseases, vaccine development lags behind community health needs.[1] To further complicate matters, the places affected by poverty diseases often lack the infrastructure to support wide-scale vaccination, and face many competing health and social priorities, such as poverty, violence, and poor roads.[1], [10] Public health and medical officials must make difficult decisions about which health needs to address, and how to incorporate vaccination into often-scarce services.

Examples of disparities in the United States and globally signal the need for continued efforts to ensure equal opportunities to people to benefit from vaccination.


Sources

  1. University of Pennsylvania Center for Bioethics. Issue Briefs. Accessed July 31, 2014.
  2. Duffy J. School vaccination: The precursor to school medical inspection. J Hist Med Allied Sci. 1978;33:344-55.
  3. Sencer DJ, Dull HB, Langmuir AD. Epidemiological basis for eradication of measles in 1967. Public Health Rep. 1967;82:253-6.
  4. Malone KM, Hinman AR. Vaccination mandates: The public health imperative and individual rights. (104 KB). Atlanta, GA: Centers for Disease Control and Prevention. Accessed July 31, 2014.
  5. Centers for Disease Control and Prevention. State immunization requirements 1998-1999. Atlanta, GA: U. S. Department of Health and Human Services, 1999.
  6. Salmon DA, Omar SB. Individual freedoms versus collective responsibility: Immunization decision making in the face of occasionally repeating values. Emerging Themes in Epidemiology. 2006;3:1-3.
  7. Javitt G, Berkowitz D, Gostin LO. Accessing mandatory HPV vaccination: Who should call the shots? Journal of Law, Medicine, and Ethics. 2008:384-395.
  8. Colgrove J. The ethics and politics of compulsory HPV vaccination. N Engl J Med. 2006;355:2390-2391.
  9. Feikin DR, Lezotte DC, Hamman RF, Salmon DA, Chen RT, Hoffman RE. Individual and community risks of measles and pertussis associated with personal exemptions to immunization. JAMA. 2000;284:3145-3150.
  10. Caplan AL, Schwartz JL. Ethics. In: Plotkin SA, Walter OA, Offit PA, eds. Vaccines. 5th ed. Philadelphia: Saunders, 2008.
  11. Snider DE. Ethical issues in tuberculosis vaccine trials. Clin Infectious Diseases. 2000;30 (Suppl 3):S271-5.
  12. U.S. Department of Health and Human Services. Special Protections for Children as Research Subjects. Accessed July 31, 2014.
  13. Krosin MT, Klitzman R, Levin B, Cheng, J. Ranney, M. L. Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa. Clin Trials. 2006;3:306-313.
  14. UNAIDS. Ethical considerations in HIV prevention vaccine research. (895 KB). Geneva: UNAIDS; 2004 (reprint);04-07E:1-52. Accessed July 31, 2014.
  15. Beloqui J, Chokevivat K, Collins C. HIV vaccine research and human rights: Examples from three countries planning efficacy trials. Health and Human Rights. 1998;3:38-58.
  16. Centers for Disease Control and Prevention. Fact Sheet for Vaccine Information Statements. Accessed July 31, 2014.
  17. Florida House of Representatives. CB/HB33: Childhood Vaccinations. Accessed July 31, 2014.
  18. Grady D. With few suppliers of flu shots, shortage was long in making. New York Times. October 17, 2004. Accessed July 31, 2014.
  19. Immunization Grant Program - Section 317. Accessed July 31, 2014.
  20. Lees KA, Wortley PM, Coughlin SS. Comparison of racial/ethnic disparities in adult immunization and cancer screening. Am J Prev Med. 2005;29:404-11.

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Last update 31 July 2014

Timeline Entry: 7/6/1885 Rabies Vaccine Used in Human

The Historical Medical Library of The College of Physicians of Philadelphia
A 1923 commemorative tag pictures the attack on Joseph Meister, the first person on whom Pasteur successfully used rabies vaccine.
 
The Historical Medical Library of The College of Physicians of Philadelphia
Pasteur wrote this letter to Emile Roux requesting him to send vaccine to Joseph Lister.
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Pasteur successfully prevented rabies in nine-year-old Joseph Meister by post-exposure vaccination.

Meister’s mother brought the boy, severely bitten by a rabid dog, to Pasteur in hopes of preventing the disease. Several factors made Pasteur’s potential involvement in the boy’s care controversial.

Pasteur had never before successfully used the vaccine on a human. (Pasteur’s notebooks indicated that two previous attempts had been made. One involved a 60-year-old man who left the hospital after only one injection and did not return. The other was 10-year-old girl, treated with one injection, who died before the second could be given.)The concept of attenuation of viruses and bacteria was in its infancy at this time. Injecting a human with a disease agent, even a weakened one, was a new and controversial action. Pasteur was not a medical doctor and might have faced serious consequences had Meister not survived the injections.

Pasteur felt certain that the boy would die from rabies infection if he did nothing. So he began the course of 13 injections, one each day, of vaccine made from rabbit nervous system tissue. Each successive injection contained a less-attenuated (stronger) virus.

Meister never developed rabies, and the incident was regarded as a success. Later in life, Meister worked as caretaker of Pasteur’s tomb at the Institut Pasteur in Paris.

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Timeline Entry: 2/27/1950 Koprowski Tests Polio Vaccine on Children

Footage courtesy of The Vaccine Makers project
Hilary Koprowski discusses his work on poliovirus vaccine.
Footage courtesy of The Vaccine Makers project
Koprowski's OPV results, 1951
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Researcher Hilary Koprowski at Lederle Laboratories conducted the first human trial of his attenuated oral poliovirus vaccine at a New York State facility for intellectually disabled children and children with epilepsy. He tested his Type II vaccine, developed with co-researcher Herald R. Cox (1907-1986), on 20 children and demonstrated that none of them became ill with polio and all of them developed Type II poliovirus antibodies.

At the time, Koprowski’s methods generated considerable controversy among others who were working on experimental vaccines. Many thought that the move to testing a live vaccine in human subjects was premature, and some objected to testing the vaccine on institutionalized children, though the practice was frequent in this era.

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diseases-and-vaccines

Assessment Questions

Vaccine mandates were first passed for _____________ vaccination.
A) smallpox
B) diphtheria
C) HPV
D) polio
True or false? A potential ethical dilemma in the development of HIV vaccines is the stigma that clinical trial participants might face.
A) True
B) False
An example of an ethical issue related to access to vaccines is ______________.
A) giving a vaccine for a sexually transmitted diseases
B) the fact that vaccination mandates value public health over individual rights
C) the lack of vaccines for so-called poverty diseases
D) the challenge of testing vaccines on young children
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