Ethics of

Vaccination
Erin McDade, Pharm.D., BCPPS
Clinical Pharmacy Specialist
Pediatric Pulmonary Medicine
Texas Children’s Hospital
 Objectives
•Review the historical impact of vaccine refusal on outbreak of communicable
diseases

•Understand the basic principles of ethics and how they apply to vaccination

•Discuss the following scenarios and the ethical dilemmas posed by each:
‐ Mandatory influenza vaccination for healthcare professionals
‐ Mandatory vaccination of school children
‐ Physician dismissal of families who refuse vaccination

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 History of Immunization in the USA

https://www.youtube.com/watch?feature=player_detailpage&v=CuJJkdQQipk
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 Stanley A. Plotkin & Susan L. Plotkin. Nature Reviews Microbiology 9, 889‐893Page
(December
4 2011)
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 Herd Immunity

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 Measles Outbreaks
•1991 Philadelphia, PA
‐ ~1400 cases reported
‐ 9 children died
‐ Associated with two church congregations that did not believe in vaccination

•2015 Anaheim, CA
‐ ~100 cases reported
‐ Linked to anti-vaccine movement in CA

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 Pertussis Outbreaks
•Washington state 2011-2012
‐ >2500 cases
‐ ↑ by 1300%

•California 2010
‐ >9,000 cases
‐ 10 infant deaths
‐ Highest spike since 1947

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 Page 9

Page 9 Omer SB, et al. Am Journal of Epidemiology 2008;168:1389‐96.

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 Ethical Principles

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 Basic Ethical Principles
•Autonomy

•Beneficence

•Non-maleficence

•Justice

•Best Interest Standard

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 Autonomy
•Recognizes the rights of individuals to self-
determination
‐ Respect for individuals to make informed decisions
‐ Informed consent

PRO VACCINATION ANTI-VACCINATION

• Other ethical principles (beneficence) • Consent/Assent must be attained prior
may overrule autonomy to vaccine administration
o Personal autonomy may be
infringed upon to protect the
greater good of the group

https://scholarblogs.emory.edu/philosophy316/2014/02/24/public‐health‐and‐respect‐for‐personal‐autonomy/
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 Beneficence
•Promote the well being of others
‐ Taking actions that serve the best interest of the patient
‐ Putting the patient first

PRO VACCINATION ANTI-VACCINATION

• Compulsory vaccination programs:
protecting children against
communicable diseases as long as
vaccines are safe for them (no
allergies to vaccine components, etc.)
• Compulsory vaccination programs
infringe upon a persons right to
autonomy

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 Non-maleficence
•“First, do no harm” concept

PRO VACCINATION ANTI-VACCINATION

• By refusing vaccines, parents could be • Mental harm to parent/patient, telling
committing maleficence them their belief is wrong
o Unimmunized child could spread
disease
o Major threat of harm to those
who cannot receive vaccine

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 Justice
•Fair treatment of individuals → Equitable distribution of healthcare
dollars and resources

PRO VACCINATION ANTI-VACCINATION

• Cumpulsory vaccination means all children • Compulsory vaccination denies the

regardless of race, religion, and culture parent/patient the freedom of choice
should be vaccinated

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 Best Interest Standard
•Making decisions based on the child’s best interest

PRO VACCINATION ANTI-VACCINATION

Moderate to severe reactions to Parents view “risks” associated with
vaccinations are rare and the benefit of vaccination to outweigh benefits
vaccination outweighs these risks, unless
medically contraindicated. Therefore,
vaccination is in the best interest of every
child.

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 Mandatory Influenza Vaccine
for Health Care Personnel?

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 Influenza Vaccination Among Health Care
Personnel (HCP)
•Advisory Committee on Immunization Practices (ACIP)
‐ Reduce the spread of influenza
‐ Reduce staff illness and absenteeism

•American College of Physicians Board of Regents

‐ Mandatory influenza vaccine for HCP, unless medical or religious objections

•Joint Commission on Accreditation of Healthcare Organizations

‐ Requires all accredited institutions provide access to influenza vaccination

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 Healthy People 2020

55.8% 61.5% 66.9%

https://www.healthypeople.gov/2020/data/Chart/6361?category=1&by=Total&fips=‐1
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 Who is mandating influenza vaccination
•Arkansas
‐ Penalizes hospitals for failure to comply with vaccination requirements

•Maine
‐ Incompliant HCP can be placed on unpaid leave
‐ “Clear danger to the health of others”

•Rhode Island
‐ Unvaccinated required to wear mask
‐ $100 fine if no mask while caring for patients

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PRO MANDATORY INFLUENZA ANTI-MANDATORY INFLUENZA
VACCINATION VACCINATION

• Influenza is a serious threat • Violates an individuals right to refuse unwanted

 23,000 influenza related deaths annually treatment/the right to informed consent
 $10.4 billion in healthcare costs, $87.1 in economic • Mandatory vaccination has not been proven to reduce
burden annually patient morbidity and mortality
• Influenza vaccine are a critical necessity for controlling  Thomas RE. et al. Cochrane Database Syst Review
morbidity and mortality in high risk patients 2013;7:CD005187
 Ahmed F. Clin Infect Dis 2014;58:50‐7. • Influenza vaccine is not the only way to protect patients
• Working in healthcare is a choice that comes with a set  Isolation
of obligations  Improving infection control
 To place patients’ interests above their own  Washing hands
 “To do no harm”  Staying home when sick
 Be an example to the public in terms of disease • What about HCP with no direct patient contact?
prevention

Dubov A, Phung C. Vaccine 2015;33:2530‐2535. Page 22

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 Mandatory Vaccination for
School Children?

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 Mandatory Vaccination for School Children?
•Since the 1980s all states have had immunization requirements for
school children

•State law varies regarding acceptable exemptions

‐ Medical (allowed by all states)
‐ Religious (allowed by 48 states – including Texas)
‐ Philosophical (allowed by 18 states – including Texas)

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 http://vaccinesafety.edu/cc‐exem.htm Page 25

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 Religious Exemption
•States vary on how they enforce
‐ “Religious sincerity” hearing
‐ Written documentation that beliefs are not compatible with immunizations
‐ Check box
‐ Sign a form

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 Religious Exemption: Measles in Philadelphia
•1991 Epidemic

•Two fundamentalist Christian churches were at the heart of the

outbreak
‐ Exercised their right to refuse vaccination on religious grounds
‐ Also refused medical treatment

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 When is Vaccine Refusal Medical Neglect?
•Medical neglect = “parent’s failure to obtain adequate medical care
for a child despite having the ability to do so”

•AAP regards medical neglect as child abuse

•Unclear how medical neglect applies to vaccine refusal

‐ US Supreme Court
• “right to practice religion freely does not include the liberty to expose the
community of the child to communicable disease or the latter to ill health or
death”

Prince v Commonwealth of Massachusetts, 321 US 158 (1994)

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Asser SM, Swan SR. Pediatrics 1998;101:625‐9.
Page Bernlinger N. Virtual Mento 2006;8:681‐4.
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 Philosophical/Personal Belief Exemption
•Most have strong beliefs about “link” between vaccines and autism

•Alternative medicine

•Lack of knowledge about lethal childhood illnesses

•Lack of understanding of herd immunity

•Government opposition

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 Philosophical/Personal Belief Exemption
•Case-control study of parents who filed for non-medical vaccine
exemption
‐ Parents who filed for vaccine exemptions were more likely to think
• Their children had a low susceptibility of the diseases
• The severity of the diseases was low
• Efficacy and safety of the vaccines was low
‐ Most frequent reason for not vaccinating children
• Concern that the vaccine might cause harm (69%)

Arch Pediatr Adolesc Med. 2005;159:470‐476 Page 30

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 Philosophical/Personal Belief Exemption
•“Because you simply don't want to offer your child up for what appears to be no more than
a human experiment?”

•“My philosophical reason is that I don't believe in messing with the immune system in an
unnatural way that is not well understood and has never been tested for long-term safety.”

•“Personally I am an atheist and believe in evolution. I feel that attacking a bacteria in an

unnatural way is going to cause the bacteria to respond to its environment and evolve. So
I think that things like vaccines are actually making diseases worse because bacteria are
very evolutionarily adept. It is like when they treat mouse plagues by poisoning the mice
and then the birds of prey die causing the mice to reproduce in greater numbers because
there is nothing to control them. We have learned over and over again that screwing with
mother nature has consequences but we can't ever seem to learn that lesson.”

http://www.mothering.com/forum/47‐vaccinations/537241‐what‐some‐philisophical‐reasons‐not‐
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 Exemptions in Texas
•Texas
‐ (a) physicians to write medical exemption statements that the vaccine(s) required
would be medically harmful or injurious to the health and wellbeing of the child or
household member
‐ (b) parents/guardians to choose an exemption from immunization requirements for
reasons of conscience, including a religious belief

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PRO MANDATORY VACCINATION OF ANTI-MANDATORY VACCINATION OF
SCHOOL CHILDREN SCHOOL CHILDREN

• Vaccination is not just about individual rights, it is
necessary to consider public health ethics
 The choice NOT to vaccinate effects more than the • Mandatory vaccination may trade off the right to decent
single child, but those around them who cannot get
vaccinated for legitimate medical reasons.
• The personal choice of a parent not to vaccinate ignores
the rights of the child to science‐based preventive
medical care.
• Justice principle demands that in mandating vaccination,
everyone from geographically, socioeconomically, or
otherwise disadvantaged populations have equal access
to vaccines.
• Violates an individuals right to refuse unwanted
treatment/the right to informed consent.
education with the right to health.
 Preventing children to attend school is ethically
questionable due to the potential discrimination
against those of lower socioeconomic status who
cannot afford or orchestrate an alternative to public
education or receive exemptions.

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 Role of the Healthcare Provider
•Listen carefully and respectfully

•Be honest about what is and is not known about risks/benefits

•Attempt to correct any misperceptions and misinformation

•Assist in comparing risks of vaccination and risks of being

unimmunized

•Revisit immunization discussion on each subsequent visit

Diekema DS. Responding to parental refusal of immunization of children. Pediatrics 2005; 1428‐31.
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 If parents still refuse
•Good documentation of conversations of risks/benefits
‐ To avoid potential liability

•Consider a vaccination refusal waiver

•What about dismissing patient from practice?

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 Dismissing Patients Who
Refuse Vaccination?

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 Ethics of Refusing to Care for Vaccine Refusers
•HCPs should “avoid discharging patients from their practices solely
because a parent refuses to immunize his or her child”

•However…
‐ If “a substantial level of disrupt develops”
‐ “Significant differences in philosophy of care emerge”
‐ “Poor quality of communication persists”
… the HCP may consider encouraging the family to find another provider

Salmon DA. Hum Vaccin. 2008 Jul‐Aug;4(4):286‐91. Epub 2008

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 Termination of Physician-Patient Relationship
•“Physicians have an obligation to support continuity of care for their
patients. While physicians have the option of withdrawing from a
case, they cannot do so without giving notice to the patient, the
relatives, or responsible friends sufficiently long in advance of
withdrawal to permit another medical attendant to be secured.”

AMA Code of Medical Ethics: Opinion 8.115 Page 41

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 Legal Considerations
•Liability
‐ Negligence –harm to a patient if the physician had duty to the patient and failure to
meet that duty = patient harm
‐ Professional misconduct – if professional code of ethics is violated

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 Ethical Considerations
•Individual level
‐ Patient is practicing autonomy
‐ Patient may become marginalized and vulnerable if not able to find other care = health
inequities

•Population level
‐ Decreasing population immunization rates, compromises herd immunity, results in
outbreaks/epidemics
• Those who can not get immunized due to age or medical reasons are no longer
protected

•Public health ethical solidarity

Halperin, et al. Paediatr Child Health 2007;12:843‐5. Page 43

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 Ethical Considerations for the HCP
•Are providers who support rejection of vaccine committing an
unethical act?

•Are unvaccinated children posing a risk to clinic staff and other

patients?

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 O’Leary ST, et al. Pediatrics 2015; 136:1‐9. Page 45

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 Guidance from Redbook
•“Continued refusal after adequate discussion should be acknowledged
and no further action taken unless the child is put at additional risk of
serious harm (e.g., during an epidemic). Only then should state
agencies be involved to override parental discretion on the basis of
medical neglect. When significant differences in philosophy of care and
concerns about practice of care (e.g., recalling that a child is under
immunized at each sick visit and urgent call) emerge or poor quality of
communication persists, a substantial level of distrust may develop.
The pediatrician may choose to encourage the family to find another
physician or practice after providing sufficient advance notice in writing
to the patient or parent/legal guardian.”

American Academy of Pediatrics. Active Immunization. In: Kimberlin DW, Brady MT, Jackson MA, Long SS, eds. Red Book: 2015 Report of the Committee on
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Infectious Diseases. 30th ed. Elk Grove Village, IL; AAP:2015:12‐13.
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 Summary
•History has shown that refusal of vaccines is linked with the outbreak of vaccine-preventable
diseases

•Five basic ethical principles can be applied to the topic of vaccination

‐ Autonomy
‐ Beneficence
‐ Non-maleficence
‐ Justice
‐ Best Interest Standard

•There are a variety of ethical dilemmas relating to

‐ Mandatory influenza vaccination of healthcare professionals
‐ Mandatory vaccination of school children
‐ Physician refusal to care for those who refuse vaccination

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 Ethics of
Vaccination
Erin McDade, Pharm.D., BCPPS
Clinical Pharmacy Specialist
Pediatric Pulmonary Medicine
Texas Children’s Hospital