Leian Lu

Professor Amy Locklear

English 102

April 24th, 2021

Ethical considerations when conducting immunization programs

Currently, the US vaccination program has been deployed for a long period of time, since

the first vaccine was founded by Edward Jenner and continue to blossom in the 1940s until now

(Kołłątaj, Witold, 2020). While that this program has provided significant public health benefits,

but at the same time there was an anti-vaccine movement occurring in the recent time, significantly

reducing the program's coverage and its efficiency. However, the majority of controversial debates

surrounding vaccines focus mainly on their ethical consideration. This not only reduces people's

confidence in the government but also directly affects public health, placing an exceptional burden

on the healthcare sector. Therefore, it is imperative to have public, transparent, and relevant

information about the ethical consideration of vaccines. For that reason, I strongly believe that it is

extremely important to have a thorough understanding of ethical considerations during vaccine

development and deployment so that the general public will have the full information regarding

their concerns. This action should be paid attention to and carefully considered by the vaccine

developers and authorities. Vaccine’s ethical questions should relay at three main aspects: safety,

legal, and accessibility consideration, and it should conclude that vaccine development can fulfill

its requirement and expectation for the safety of the mass population.

I. History of vaccines: 
 The Centers of Disease Control and Prevention defines vaccines as “an antigenic

preparation derived from pathogenic microorganisms, that has been formulated to ensure the

necessary safety, making the body self-immune against pathogens” (CDC, 2018). When the

vaccination program is working, most people are vaccinated against the disease, sometimes the

disease can completely disappear from the community and the vaccination program may stop. In

the journal “Anti-Vaccine Movements – a Form of Social Activity for Health Care, Ignorance or

Diversion Aimed at Destabilizing the Health Situation”, Kołłątaj and Witold claims that “taking

into account the well-being of the entire population, vaccinations have an impact on extending life

expectancy, reducing the number of complications of infectious diseases, including reducing the

scale of disability, improving the quality of life of the population, saving (reducing sickness

absence, reducing expenditure on the treatment of diseases and their consequences) and adjusting

the epidemiological risk level to WHO and EU requirements” (Kołłątaj, Witold, 2020). However,

for some diseases such as measles, if the vaccination program is stopped, the rate of immunization

decreases, the disease will break out very quickly.

“Several factors need to be considered before a vaccine is deployed: the potential burden of

disease; vaccine-related risks (usually minimal); the desirability of prevention as opposed to

treatment; the duration of the protection conferred; cost; herd immunity in addition to individual

protection; and the logistical feasibility of a large-scale vaccination programme” (WHO, 2013).

While each individual will target their focus on different aspects, this essay would round up and

discuss the concern over safety measures, legal enforcement, and accessibility – as would be seen

later on to be among the most concerning issues in public’s opinions.

It is important to note that in the early years of vaccine researches, in the 1980s to be

specific, safety guidelines were always in priority concerns after the concern over the safety of
children’s vaccines was surging. Given the case of how the National Childhood Vaccine Injury Act

was passed, it is crucial to ensure that everyone was well informed about the vaccine development,

safety guidelines, risks, and benefits of vaccination (Institute of Medicine, 2010).

Further than that, the Advisory Committee on Immunization Practices (ACIP) – a group

designed to oversee the development and approval process of the vaccine development, further

given the recommendation and guidelines for the citizens to ensure the efficiency of immunization

programs – was founded in 1964. The guidelines and recommendations from ACIP will, later on,

be the official guidelines of the government. This means that the attention to the issue was stated

early in the history of vaccines, and consistently changed and adapted to fulfill the public’s

requirement. But it also needs to state that several things need to be considered over the supervisor

roles of ACIP in the private companies’ researches, especially when they only mainly receive and

viewing the process by viewing the scientific researches and re-evaluating the final results such as

trials results, packaging, cost, and liability, but not exclusively involved in the making process.

Later on, other bodies were founded to fulfilled and assist ACIP in its role to provide a thorough

guideline as well as oversee the making process of vaccines, named as Center for Biologics

Evaluation and Research, a department in the Food and Drugs Administration (FDA).

1. Stages of vaccine development: 

The vaccine manufacturing process is complex, which requires several years for the entire

process to be completed. Initially, the vaccine will be studied in collaboration with government

researchers in partnership with the private sector, and then under corporate sponsorship, it will

progress to the testing phase. Ethical consideration in the vaccine development process revolves

mainly in this testing process. The testing process is divided into 2 phases: animal testing and

human testing, in which human testing continues to be divided into 3 more specific stages. Phase 1
of human trials will take place in a small group of different ages, if the vaccine is given to children,

then testing will be done on groups with higher age and the age of the participant will gradually

decrease over time as they reach the age to receive the vaccine. Stage 2 is similar, but with a larger

number of participants and includes those who are most likely to be infected. And phase 3 is the

testing phase with hundreds of thousands of people, to test the effectiveness and coverage of the

vaccine. The follow-up and testing of this testing process are mainly done through reports

submitted to FDA and ACIP periodically.

2. Controversial opinions over ethical consideration of vaccine:

Many conflicting opinions on the vaccine testing process have been raised over the years,

which can be categorized based on three main aspects: Safety guidelines; Legal considerations, and

accessibility considerations.

In terms of the safety guidelines, the majority of the controversial debate focused on the

safety measure and consent level in human trials and if the clinical trials and deployments on

vulnerable groups such as children and people with chronic illness are safe or not. These debates

mainly focus on the fact that while the government has control over the testing, no supervisor

action was taken further than evaluating the result from periodical reports.

In terms of legal considerations, people generally concern over current regulations being enforced

on vaccine trials. This argument mainly stays on the consent of participants in the process of

human trials, along with the lack of awareness of authorities over this specific stage in vaccine

development process.

And finally, in terms of accessibility considerations, it should be the most concerning issue

that has a huge impact on the effectiveness of the immunization program. The publics’ opinion

mainly focuses on the affordability of the vaccine and the chances to access the vaccine for certain
groups. Medical treatments are not cheap and should there be a program of financial assistance to

different groups that lack financial stability. Furthermore, there are concerns that people from

vulnerable groups and different ethics are having a hard time having their vaccine doses, especially

in the past few years, when the divide in the US society growing stronger. 

II. Safety Consideration:

1. The measure took by vaccine’s developers and authorities to ensure safety guidelines

is strictly followed.

As explained above, the vaccine testing process goes through many different stages, with

the extent of the samples becoming increasingly complex and broader in terms of quality and scale.

According to WHO, “monitoring adverse vaccine reactions is a major safety component of pre-

licensure clinical trials” (WHO, 2013). Interfering with this testing process by supervisors is often

not recommended due to confidentiality reasons, as a result of the high level of competition

between pharmaceutical companies and vaccine centers. However, disclosing this information does

not affect vaccine safety, as vaccine testing procedures have been carefully developed with a

reasonable path, starting from animal testing, to human testing. From 100 people at the starting

point, it can be up to approximately 10,000 people in the final stage, with a wide range of ages and

physical abilities to be able to assess the overview effect of the vaccine.

In addition, ensuring the safety of vaccines is not only deployed during development but

also after being licensed. The authorities will still monitor and collect information about possible

reactions from vaccine receivers. This was evident in the cases of the COVID-19 vaccines of

AstraZeneca and Jonhson & Jonhson, following reports of cases of blood clots in the brain after the

vaccination process. Although the number of cases is small compared to the vast coverage of the
two vaccines, the rapid response of companies and authorities has shown the concern and deep

attention of stakeholders concerning the extent of vaccine safety.

2. The counter arguments:

Revisit the National Childhood Vaccine Injury Act was stated at the beginning of the

research, it was a perfect example of how authorities value the importance of safety guidelines and

the public’s understanding of the issue. The law came after a series of criticism and unproven

claims about the side effects of the pertussis vaccine, which can cause brain damage and even

autism (Institute of Medicine, 2010). Although later, many reports have analyzed and pointed out

that the above points were false and misleading, the public still shows obvious confusion and

suspicion of vaccination in general. This Act is designed to strengthen public confidence in the

safety of vaccines as well as to ensure the responsibility of stakeholders with the implementation of

the vaccination program. Similar drastic actions have been repeatedly taken, along with a

combination of regulators such as the FDA, CDC, or ACIP, all expressing a deep concern for the

safety of vaccines in the process of development and deployment. This is completely

understandable, given the risk between the safety of a large population, as well as the success or

failure of building community immunity and the likelihood of success in the battle in any

pandemic.

i. Clinical trials and deployments on vulnerable groups:

Another controversial opinion of ethical consideration is about consent in too human trials.

This concern mainly revolved around whether participants were fully aware of the risks of

participating in trials, especially when medical knowledge and terminology were rather confusing

to the most of population. However, this has been ensured when the participants are given specific
instructions, from the documentation to the explanation of the specialist, are provided with full

information about the use, ingredients and mechanism of the vaccine, and the possible responses

toward the vaccine trial. Participants or guardians of those taking part need to have a high

understanding of the vaccination and testing process and have sufficient cognitive capacity before

joining. This is supervised and guaranteed by a team of nurses, doctors as well as lawyers to ensure

the interests of all parties involved. 

This also means that the vulnerable groups, especially children, cannot be the subjects of

the test until now. This causes a dilemma on how to ensure the safety of the vaccine in deployment

to such groups and simultaneously maintain the moral line. For the given reasons, to maintain

ethical consideration but simultaneously ensure the safeties of the vaccines, there are multiple ways

were conducted to tackle the problem, especially by scientific shreds of evidence through

researches. 

III. Legal consideration: Regulations being enforced on vaccine trials:

Each step is closely supervised not only by the organizations themselves but also

authorities. As stated above, all stages are closely followed by authorities and supervisors. The

human trial stages need to have the consent of participants and authorities. This stage requires

mandatory updates both in statics and detail researches, usual updates on trials. And later on, at the

licensing stage, there is cross-checked between different authorities over the results of trials and

scientific researches, and the whole process may need years to be qualified for mass immunization

programs.

The lack of individual and authorities’ awareness and responsibilities is still among the

most concerning challenges that is needed to be worked on. A 2008 case study on how healthcare
workers are one of the groups that is the least likely to be vaccinated against influenza, even

though healthcare workers with influenza can easily pass the virus to their patients in Newell,

Alexa’s “Preventing Flu in Health Workers: Vaccination Challenge Is Launched” article will

illustrate the significant impact of healthcare providers and health worker to be the role model in

getting vaccination (Newell, Alexa, 2008). This also demonstrates the lack of individual and

authorities’ awareness and responsibilities in making immunization programs efficient and

accessible to the public. We must consider another fact that is these health-care workers have been

given access to official immunization recommendations and free, voluntary immunization

programs. This left only one explanation to the low influenza vaccination rates among the health-

care workers, which is that the health-care workers are not aware of the importance of getting

vaccinated for themselves and for the sake of their patients. Another research that I found is that

the immunization rates among preschool children in the United States are significantly low. The

measles epidemic, which resulted in about 55,000 cases and 132 measles-related deaths (CDC,

1993a), was tragic evidence that vaccine-preventable diseases such as measles, rubella, diphtheria,

and pertussis remain a threat. (Institute of Medicine, 34) While the health-care workers are fully

grown adults, who are highly educated in the health sector should be responsible for getting

vaccinated, we cannot ask preschool children to take that responsibility. This proves that there is a

lack of responsibilities from local health departments, individual providers as well as the barrier in

knowledge, attitude and behavior of children’s families.

IV. Accessibility:

The cost of vaccines can raise a problem to immunization programs over how lesser and

vulnerable groups with limited access to the health care system can access this program. These
groups are mainly children from families with few conditions and low access to health care, the

elderly, and many other disadvantaged groups. With health care costs rising in recent years in the

US, access to similar services has become increasingly difficult. But these people are also the

group at higher risk of infection than other groups because their awareness of diseases and the

ability to access information about disease prevention are remarkably low. For the above reasons, it

is imperative to provide a health regime through the national aid packages, for humanitarian

reasons as well as for the benefit of the overall public health.

Vaccine affordability and immunization programs’ accessibility is a challenge that has a significant

impact on immunization programs in the United States. The National Immunization Survey-Teen

is a survey among caregivers of adolescents and vaccination providers by the mean of telephone

and mail. It was conducted in order to make an estimation of vaccination coverage in the U.S by

comparing the vaccination coverage between foreign-born and U.S.-born adolescents. “Foreign-

born adolescents had significantly lower unadjusted vaccination coverage for HepB. Coverage was

significantly lower among foreign-born adolescents, compared with U.S.-born adolescents.”

(National Immunization Survey-Teen, 2012) This illustrates the challenge with vaccine

affordability and inequality in access to immunization programs within the United States based on

one's insurance status, education, language, and household size. Not only the inequality contributes

to the inaccessibility of immunization services, but there are also complexities of the immunization

schedule and incomplete information about children's immunization status that do the same.

Distribution based on one's insurance status, education, language, and household size also

can pose an ethical issue. Not only the inequality contributes to the inaccessibility of immunization

services, but there are also complexities of the immunization schedule and incomplete information

about children's immunization status that do the same. This can happen due to the lack of resources
in a time of high demands, or even more socially deep-rooted problems. The ultimate goal of

distributing vaccines following strict rules is to protect those at greater risk, saving most lives as

possible and ensuring societal benefits, the real-life application might not follow the same rules,

when the information and application depend on such a diverse population with different accesses

and status, along with others concerns (Williams, Jane, 2021). This imposes a significant problem

to the immunization programs that up until now, there seems to be a lack of truly efficient solution.

V. The importance of ensuring ethical consideration:

It is non – debatable of the importance of vaccines to maintain the public’s health, and

while in some cases, the ethical line can cause a dilemma in the development process, but it is far

more important to raise the awareness of people toward the liability of vaccine. Times as the

current COVID 19 epidemics best demonstrate the importance of providing information and

expanding the coverage of vaccines to achieve public immunity. From the above arguments and

evidence, we can see that ethical consideration is always a priority in the policy of monitoring,

developing, and implementing vaccines to achieve immunity. However, this attention is mostly

demonstrated in vaccine implementation and research, with scrutiny and a multi-stakeholder

process coordinated, while the distribution process and post-deployment surveillance, in particular,

has many shortcomings, even though this specific issue plays an exceptional crucial role in the

success or failure of the vaccination program. A loophole in the program could cause a more

catastrophic pandemic as the virus's strain could evolve very rapidly, and the virus's ability to resist

vaccines could completely develop.

With that to be stated, the need to prioritize the moral concern and public the information

regarding this issue is extremely important and requires further actions of authorities, especially

while both legal and safety consideration is carefully designed, severe concerns still lay at the
accessibility of people to immunization programs. Therefore, when revisiting the thesis about the

importance of providing a clear and transparent system of ethical consideration to increase the

understanding and awareness of the people, the article proves that this thesis statement was

adequately made. This calls for action from all related stakeholders: vaccine developers need to

have systems that are easy to access, easy to understand for the majority of information during

testing. There is a greater emphasis on each step of development, as well as the distribution of

vaccines among disadvantaged and vulnerable groups in society. Such actions will ensure a

seamless and efficient implementation of the vaccination program, providing the ultimate benefit

for the whole community, as well as strengthening people's confidence in the health care and

vaccine system in a sustainable way.

Work Cited

Ducharme, Jamie. “New York City Is Requiring Some Residents to Get Vaccinated Against

Measles. Is That Legal — And Ethical?” Time Magazine, 10 Apr. 2019,

time.com/5567422/mandatory-vaccination-legal-ethics/. 

“Ethical Considerations for Vaccination Programmes in Acute Humanitarian Emergencies.” World

Health Organization, 26 Mar. 2013, www.who.int/bulletin/volumes/91/4/12-113480/en/.

Healy, Rodriguez-Lainz, Elam-Evans, Hill, REagan-Steiner, and Yankey. "Vaccination Coverage

among Foreign-born and U.S.-born Adolescents in the United States: Successes and Gaps -

National Immunization Survey-Teen, 2012-2014". Vaccine, vol. 36, issue 13, March. 2018,

pp. 1743 - 1750. Sciencedirect, doi:10.1016/j.vaccine.2018.02.052.

“Immunization Basics.” Centers for Disease Control and Prevention, 16 May 2018,

www.cdc.gov/vaccines/vac-gen/imz-basics.htm#:~:text=Definition%20of%20Terms,-Let's

%20start%20by&text=Vaccine%3A%20A%20product%20that%20stimulates,or%20sprayed

%20into%20the%20nose.

Institute of Medicine (U.S). "Accountability and Responsibility for Providing Immunizations."

Overcoming Barriers to Immunization: A Workshop Summary. E-book, Washington, DC:

The National Academies Press, 1994, pp. 34-38. 

Institute of Medicine (U.S.). "3: Informed Vaccine Decision Making."Priorities for the National

Vaccine Plan. E-book, National Academies Press, 2010 

Kołłątaj, Witold, et al. “Anti-Vaccine Movements – a Form of Social Activity for Health Care,

Ignorance or Diversion Aimed at Destabilizing the Health Situation? Part 1.

Epidemiological Safety. Vaccinations – Pros and Cons.” Annals of Agricultural and

Environmental Medicine, vol. 27, no. 4, 2020, pp. 544–552., doi:10.26444/aaem/126013. 

Newell, Alexa. “Preventing Flu in Health Workers: Vaccination Challenge Is Launched.”

Nursing for Women’s Health, vol. 12, no. 6, Dec. 2008, pp. 529–530. EBSCOhost,

doi:10.1111/j.1751-486X.2008.00388.x. 

Sifferlin, Alexandra. “Who Gets the Experimental Ebola Drugs?” Time Magazine, 12 Aug. 2014,

time.com/3104174/who-gets-the-experimental-ebola-drugs/. 
Williams, Jane, et al. “How Should We Conduct Pandemic Vaccination?” Vaccine, vol. 39, no. 6,

2021, pp. 994–999., doi:10.1016/j.vaccine.2020.12.059.