The vaccine decision: Report on the considerations

about whether to vaccinate or not

22616381

Assignment presented in the partial fulfilment

of the requirement for the degree of
BComHons (Actuarial Science)
at the University of Stellenbosch

Supervisor: Mrs. Natalie van Zyl

Degree of confidentiality: A March 2023

 PLAGIARISM DECLARATION

1. Plagiarism is the use of ideas, material and other intellectual property of another’s work and
to present it as my own.

2. I agree that plagiarism is a punishable offence because it constitutes theft.

3. I also understand that direct translations are plagiarism.

4. Accordingly, all quotations and contributions from any source whatsoever (including the
internet) have been cited fully. I understand that the reproduction of text without quotation
marks (even when the source is cited) is plagiarism.

5. I declare that the work contained in this assignment, except otherwise stated, is my original
work and that I have not previously (in its entirety or in part) submitted it for grading in
this module/assignment or another module/assignment.

6. I understand that if were to have I received any solutions or any material, where marks were
awarded, from any previous student in this module and consulted the material for guidance
in answering the assignments, that it constitutes plagiarism.

7. I therefore declare that I do not have in my possession any previous student’s solutions and
I declare that I will not pass my solutions on to any future student.

22616381
Student number Signature

M.A. Dollie 6 March 2023

Initials and surname Date

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Copyright © 2023 Stellenbosch University
All rights reserved

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 ACKNOWLEDGEMENTS

I wish to acknowledge David Rodwell for generously creating a LATEX template based off the USB
(University of Stellenbosch Business School) guidelines which have been adapted for the purposes
of the department.

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 TABLE OF CONTENTS

PLAGIARISM DECLARATION iii

ACKNOWLEDGEMENTS iv

1 INTRODUCTION 1
1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Clarification of Key concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2.1 Vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2.2 Side Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2.3 Vaccine Infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

2 VACCINE CONSIDERATIONS 4
2.1 Positive Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1.1 Infectious disease protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1.2 Herd immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1.3 Spurious side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.2 Negative Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.2.1 Myopic vaccine trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.2.2 Severe side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.2.3 Risk-benefit misinterpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3 Neutral Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3.1 Adverse event monitoring and compensation . . . . . . . . . . . . . . . . . . 6

3 SOURCE CHECKING 7
3.1 College of Physicians of Philadelphia, 2022 . . . . . . . . . . . . . . . . . . . . . . . 7
3.2 Maier and Richter, 2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.3 BMJ Letters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

REFERENCES 9

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 CHAPTER 1

INTRODUCTION

1.1 INTRODUCTION

Vaccines are a controversial topic. Many people feel strongly about the implications, benefits and
risks regarding the decision to vaccinate. This report aims to outline considerations which might
factor into the decision process.

In order to fully consider each stance on the matter and make a decision, it can be very helpful
to understand the objective facts and also recognise that as a medical decision, it is a subjective
process.

1.2 CLARIFICATION OF KEY CONCEPTS

In this section, some clarification is given around certain objective facts about concepts critical to
understanding the topic at hand.

1.2.1 Vaccines

A vaccine is any medical product which uses an inert disease causative agent or part thereof to
prevent and protect its user completely from the disease or partially from the severe symptoms.
The way vaccines achieve this is by activating the immune system to recognise the agent as foreign
to launch an immunological response which confers protection for the specific disease in the future.

Vaccines are mostly used to prevent or treat infectious diseases, which pose a systemic risk to
society. This is important to consider in the cost-benefit analysis of vaccines, as the decision to
forego vaccination affects both oneself and society at large.

There are different types of vaccines that differ in the form of the causative agent, method of
immune stimulation, and delivery process. Although the basic objective of all vaccine types is to
elicit an immune response, their efficacy, safety, and side effects vary which significantly factors into
the decision-making process.

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1.2.2 Side Effects

Side effects are secondary effects resulting from a medical treatment which were not intended and
are typically negative and undesirable.

Vaccines have side effects, as all medical products do. Side effects resulting from vaccines are known
as adverse events. There are two main axes on which side effects in general can be scaled: severity
and causation. (College of Physicians of Philadelphia, 2022)

1. Severity
Side effects can range from mild to severe, with some being easily treatable and others po-
tentially life-threatening. Vaccines can also have short or long-term effects, with some taking
time to develop and only become apparent after long-term studies.

2. Causation
Causation refers to the level of connection between treatment and side effects. The extremes
are coincidence and perfect causation, while most fall in between those extremes either being
indirect or just correlated.

According to the College of Physicians of Philadelphia (2022) most of the side effects from vaccines
are mild and cases of severe ones are usually rare. This is an important consideration because in
the risk-benefit analysis of vaccines, one has to differentiate between the severity of the side effects
and their rarity.

1.2.3 Vaccine Infrastructure

Vaccine infrastructure involves a lengthy process from development to widespread rollout, requiring
investment in trials, supply-chain infrastructure, and monitoring. Regulators like the Food and
Drug Administration (FDA) are responsible for testing, approval, and monitoring of vaccines,
creating institutional responsibility to ensure a functional vaccination infrastructure.

Extensive tests are performed before vaccine distribution, including trials of varying stages and
sample sizes to verify efficacy and safety issues. Most vaccine trials are randomised controlled
trials (RCTs) which assign participants to a treatment or placebo group, and if the vaccine shows
significant efficacy, an ethical dilemma arises because withholding treatment from the placebo

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group would be unethical. This can lead to trials being terminated early, which reduces the study
of adverse events and ultimately leads to debate about the long-term safety implications of vaccines,
as less study time gets devoted to researching the possible side effects.

Overall, vaccine infrastructure is a complex process that requires investment in various aspects
of development, regulatory oversight, and trial testing. Understanding the ethical implications of
testing is also important in ensuring that the benefits of vaccination outweigh the risks.

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 CHAPTER 2

VACCINE CONSIDERATIONS

The report now presents positive, negative, and neutral factors from the literature review without
aiming to influence decision-making, but rather to inform the decision-maker about all aspects and
contested points with context.

2.1 POSITIVE CONSIDERATIONS

2.1.1 Infectious disease protection

Vaccines are the primary method of protection against infectious diseases and have eliminated
devastating diseases in the past. (Maier & Richter, 2013)

Vaccines provide individual and community protection against epidemics and pandemics by making
it difficult for diseases to spread. Lower vaccination rates decrease protection against severe diseases.
(Maier & Richter, 2013)

Classen and Classen (1999a) suggest the current risk-benefit analysis is flawed because it only
considers short-term adverse events, neglecting longer-term effects.

2.1.2 Herd immunity

Herd immunity protects vulnerable individuals who cannot be vaccinated, but only works when a
high enough proportion of the population is vaccinated. Defined as “the protection of the whole
population through the presence of vaccinated individuals” (Maier & Richter, 2013), it prevents
the disease from replicating and spreading enough to infect the vulnerable.

2.1.3 Spurious side effects

Jefferson (1998) suggests that many conditions, such as sudden infant death syndrome and autism,
have been falsely attributed to vaccines due to a breakdown in the scientific process. Claims of
causal links are made without peer review, and subsequent contradictory research is not given
appropriate attention. This misleads the public and fails to highlight the true cost of unvaccinated
populations or the dangers of losing public trust in vaccines. These claims arise from unreliable

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scientific research and irresponsible journalism, rather than vaccines themselves.

2.2 NEGATIVE CONSIDERATIONS

2.2.1 Myopic vaccine trials

Vaccine safety research primarily focuses on short-term adverse events during trials, with limited
attention given to long-term risks. The ethical dilemma mentioned in section 1.2.3 of withholding
efficacious treatments leads to trials ending before they can detect long-term signals, resulting in
vaccine trials being criticised for their lack of long-term risk analysis. (Jefferson, 1998; Classen &
Classen, 1999a)

Classen and Classen (1999a) believe that long-term studies are needed to assess the true long-term
implications of vaccines, citing the example of the apparent causal link between the Hib vaccine and
type 1 diabetes as evidence for this belief. Bedford and Elliman (1999) argue that this causality is
incorrect and the occurrence is merely related in time.

2.2.2 Severe side effects

Vaccines can have serious side effects such as blindness, encephalitis and death (College of Physicians
of Philadelphia, 2022). Some may be linked to chronic immunological diseases such as diabetes,
asthma and immune-mediated cancers (Jefferson, 1998). It is irresponsible to ignore these risks or
hide them from the public.

The links between vaccines and chronic diseases are disputed and require proper analysis, according
to Jefferson et al. (1999) and Bedford and Elliman (1999). They argue that the data has been
misrepresented. Severe side effects are usually rare and only generally occur in specific situations
such as those with compromised immune systems (College of Physicians of Philadelphia, 2022)

According to the College of Physicians of Philadelphia (2022), each year around 30000 adverse
events are reported following vaccination. Of these events between 10% and 15% are serious medical
situations that lead to hospitalisation, disability and even death. They do state that not all of these
events are necessarily caused by vaccines and could just represent temporal coincidences.

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2.2.3 Risk-benefit misinterpretation

The approval of vaccines is based on the belief that the benefits of immunisation considerably
outweigh the risk of adverse events (Classen & Classen, 1999a). However, they argue that due to
the delayed nature of certain long-term side effects, this analysis is flawed.

In their analysis of the link between vaccines and diabetes Classen and Classen (1999b) state that
the believed benefit reduction of 23.5 children per 100000 vaccinations (in terms of death and severe
disability) is smaller than the increased rate of type 1 diabetes in the same population.

2.3 NEUTRAL CONSIDERATIONS

2.3.1 Adverse event monitoring and compensation

In the US there are multiple systems that have been set up to monitor the occurrence of vaccine-
related adverse events. These include the VAERS and VSD. Both of these systems are designed to
allow individuals to report any adverse events to the proper channels so that proper follow-up can
occur. There are also compensation schemes which aim to provide financial relief to individuals
who have suffered injuries due to vaccine complications. (College of Physicians of Philadelphia,
2022)

These systems provide a necessary layer of protection to the public and ensure that there is some
level of consideration for when things go wrong.

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 CHAPTER 3

SOURCE CHECKING

Now I will outline the aspects of each source I would have verified if that were allowed and why.

3.1 COLLEGE OF PHYSICIANS OF PHILADELPHIA, 2022

This source was generally free of points that I would have fact-checked. Since it was authored by a
professional body, I feel confident that care was taken to ensure a unbiased source. That being said,
if I were to nitpick, one aspect of source verification I would do is to check whether the College of
Physicians of Philadelphia have any controversial opinions that buck any professional standards or
medical consensus. This would just to be ensure that they are not guilty of being anti-establishment
behaviours.

3.2 MAIER AND RICHTER, 2013

Since this source was not primarily concerned with vaccines, and instead just used a pro-vaccine
text in their experiment. I would have done fact-checking on all of the points made in the appendix
text. This would include making sure that the statements that claimed as being made by specific
german officials were actually made those individuals and that thos individuals have the stated
titles.

3.3 BMJ LETTERS

Since these letters are all related to a specific dataset on the Finnish vaccine trials and the links
between that and type 1 diabetes, I would definitely examine the original papers. These would
include

• Classen and Classen paper (originally referenced in Jefferson (1998)) which make the claim
about the link between vaccines and diabetes (“The timing of pediatric immunisation and the
risk of insulin-dependent diabetes mellitus”). The reason for doing so would be examine the
statistical methods used to conclude the association. I would also examine how they came to
the numerical conclusion of diabetes risk outweighing the benefit of immunisation, since they

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 make an explicit claim that their analysis shows a clear disadvantage to vaccine benefits.

• The two independent reviews by Cochrane and the John Hopkins Vaccine Safety Institute
mentioned in Jefferson et al. (1999), because they have reviewed the data and so I would
examine their review to find any support for or against Classen and Classen’s claims.

• The data analysis of J Tuomilehto, since his data is cited by both sides as evidence of their
respective claims, and also because Classen and Claasen claim they were collaborators on
the study while Bedford and Elliman (1999) disputes this. So I would verify which claim is
correct.

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 REFERENCES

Bedford, H. & Elliman, D. 1999. Studies of adverse effects of vaccination have duty to present full
picture. BMJ, 318(7196):1487–1488.

Classen, J.B. & Classen, D.C. 1999a. Authors’ reply. BMJ, 318(7196):1487.

Classen, J.B. & Classen, D.C. 1999b. Public should be told that vaccines may have long term
adverse effects. BMJ, 318(7177):193, doi:10.1136/BMJ.318.7177.193

College of Physicians of Philadelphia. 2022. Vaccine side effects and adverse events
[Online]. Available: https://historyofvaccines.org/getting-vaccinated/vaccine-faq/vaccine-side-
effects-and-adverse-events [2023, March 2].

Jefferson, T. 1998. Vaccination and its adverse effects: real or perceived: Society should think
about means of linking exposure to potential long term effect. BMJ, 317(7152):159–160,
doi:10.1136/BMJ.317.7152.159

Jefferson, T., Rabinovich, R. & Tuomilehto, J. 1999. Vaccines and their real or perceived ad-
verse effects: Authors’ conclusions are at odds with investigators’. BMJ, 318(7196):1487,
doi:10.1136/BMJ.318.7196.1487

Maier, J. & Richter, T. 2013. Text belief consistency effects in the comprehension of
multiple texts with conflicting information. Cognition and Instruction, 31(2):151–175,
doi:10.1080/07370008.2013.769997