Vaccination:An Obligation or a Privilege?

Vaccination:Vaccination:An Obligation or a Privilege?An Obligation or a Privilege?

Encounters in Bioethics2012-2013Dr. David WilliamsMarch 20/21, 2013

Encounters in BioethicsEncounters in Bioethics20122012--20132013Dr. David WilliamsDr. David WilliamsMarch 20/21, 2013March 20/21, 2013

Vaccination:Injecting Ethics into Public Health!

• Brings into sharp focus a critical and ongoing debate on the function of public health:– “they reveal an enduring tension between public health

and individual rights – a tension that we ignore at our own peril”. (Bayer 2007)

• US State High Court– “it is unquestionable that the legislature can confer

police powers upon public officers for the protection of the public health. The maxim Salus populi suprema lexis the law of all courts. The individual right sinks in the necessity to provide for the public good”(Parmet, 1985)

Vaccination: Just a Needle?

What are Vaccinations

• Primary vs. Booster• Active vs. Passive• Side Effect vs. Adverse Event• Injected, Oral, Inhaled• Intramuscular, Subcuticular, Intradermal• Active Agent, Antigen, Adjuvant, Preservative,

Stabilizer, • Single, Multiple agents• Inactivated (killed) or attenuated (live)

Vaccination – Communicable Diseases

• Microbes versus Armies• Communal Living : Civil Order and Law• Protecting the Public from itself!• Levitical Priesthood and other models

– Knowledge and Authority– Powers to limit and require action

• Risk appropriated authority and power• Vaccination and probabilistic risk

Vaccination or Immunization

• Definition– Was limited to the inoculation of a preparation

derived from cowpox. Later it was extended to the injection of any microbial antigen for the purpose of inducing immunity to a corresponding disease. (Last 1988)

– the administration of antigenic material (a vaccine) to stimulate an individual's immune system to develop adaptive immunity to a pathogen. (Wikepedia)

Immunization

• Definition:– Protection of susceptible individuals from

communicable disease by administration of a living modified agent, a suspension of a killed organism, or an inactivated toxin.

– Temporary passive immunization can be produced by administration of antibody in the form of immune globulin.

Vaccination/Immunization concepts

• Used interchangeably• Individual vs. Population Vaccination

– Herd Immunity– Transmission Rates– Adverse Events– Immunogenicity – Vaccine Effectiveness– Waning Immunity

Vaccination: Changing Technology

• Historically: Edward Jenner 1796 injected pus from a cowpox pustule of a dairymaid into 8 year old James Phipps to prevent smallpox.

• Whole Cell – Split Cell – Egg based –Molecular – Plant based

• Single Antigen • Cancer prevention vaccines• Immune System Modification – enhance or

reduce• Future ?

Ethical Issues/Principles

• Individual vs. Public Good• Public/Government funded Vaccination

programs• Mandatory Vaccination i.e. Health Care

Worker (HCW’s) or school pupils ( ISPA –Immunization of School Pupils Act, Ontario)

• Emergency vs. “times of Peace”

Ethical Principles

• Producing Benefits• Avoiding, preventing and removing harms• Producing the maximal balance of benefits

over harms and other costs (i.e.. Utility)• Distributing benefits and burdens fairly• Ensuring public participation of affected

parties • Respecting autonomous choices and actions,

including liberty of action

Ethical Principles continued

• Protecting privacy and confidentiality• Keeping promises and commitments• Disclosing information as well as speaking

honestly and truthfully• Building and maintaining trust

Ethics of Vaccination Programs

• Schwartz and Caplan 2011– “Ethical issues are present at each stage in the vaccine

product life cycle, the period extending from the earliest stages of research through the eventual design and implementation of global vaccination programs. Recent developments highlight fundamental principles of vaccine ethics and raise unique issues for ongoing vaccination activities worldwide. These include the 2009-2010 H1N1 pandemic influenza vaccination campaign, renewed attention to the potential global eradication of polio and the ongoing evaluation of vaccine risk controversies, most notably the alleged link between childhood vaccines and autism”

Vaccination Programs: Key Ethical Goals

• Maximize the Benefits of Vaccines in Preventing Morbidity and Mortality in all Populations;

• Minimizing exposure to severe vaccine-related adverse events;

• Minimizing infringement on the decision-making prerogatives of individuals (or parents, for vaccines administered to children)

Schwartz and Caplan2011

Vaccine Safety and Risk

• Cultural and Geographical Variability• Certain cultures opposed others demanding

more and more• Risk of disease : Risk of Adverse Event

– Not always balanced or understood– Both are not linear but probabilistic – Subjective or Objective Evidence– Weighted on bias agenda pro and con

Vaccine Safety and Risk

• MMR and Autism Spectrum Disorder– 2010 U.K. General Medical Council: Wakefield of

guilty of research misconduct and banned from practicing medicine in the U.K.

– Wakefield remains a champion of antivaccine and many uphold the accusation in the absence of evidence

– Wakefield 1998 in Lancet • Thimerosal and other addictives• Polio vaccine in Pakistan and Nigeria

Freedom of Choice: Societal Cost

• UK post Wakefield outbreaks of measles due to low coverage– Hospitalizations– Complications– Morbidity and Mortality

• Risk of Adverse Event vs. Risk of Disease• Insurance Coverage• 2010-2011 Influenza Season and ER

overload – Costs?

Vaccine Safety and Risk

• Status of ongoing debate– “Resistance to vaccination is as old as vaccination

itself”.– “Health care providers should view individuals

hesitant about or opposed to vaccines not as frustrations or threats to public health, but as opportunities to educate and inform”. (Schwartz and Caplan 2011)

• Individual Freedom versus Collective Responsibility

Individual Freedom vs. Collective Responsibility

• Individual’s wishes conflict with what is best for their health/interests?

• Individual’s rights restricted for his/her own benefit?

• Individual’s behaviour/choices go against what is best for population benefits?

• “Immunization represents a classic case of social dilemma: a conflict of interest between the private gains of individuals and the collective gains of a society”. (Sadique 2006)

Individual Choice vs. Social Optimum

• Herd Immunity– The immunity of a group or community – the

resistance of a group to invasion and spread of an infectious agent, based on the resistance to infection of a high proportion (social optimum) of individual members of the group. (Last 1988)

– Two concepts• Eliminate introduction or spread of Agent• Protection of those unable to acquire resistance

against the agent

Herd Immunity – Social Optimum

• “The benefits to society are larger than the sum of those to individuals, public policy measures aim to increase demand closer to the ‘social optimum by subsiding vaccine or through compulsory vaccination”.

• Controversy over the effectiveness of public intervention compared to the free choice outcome.

Scenario: H1N1 Pandemic 2009-2010

• New Technology introduced using Adjuvanted vaccine

• Vaccine Production underway, delayed• Expert opinions alter as to use of vaccine in

pregnancy and children prior to vaccine release

• Risk perception wanes prior to Vaccine release and doubt of second wave

• Experts debate publicly over actual impact or true existence of Pandemic

Scenario: H1N1 Pandemic continued

• Statistically sound polling shows limited uptake desired of vaccine

• First child death second wave minimal impact• Second child death, young hockey player

causes nation wide sudden demand for vaccine

• Vaccine availability priority causes public and media outcry in some urban settings

• Final coverage less than 50%

Vaccination Ethics in Emergency

• Priority Vaccination in limited supply• Required Vaccination of some sectors• New technology with unknown risks• Risk of disease acquisition uncertain• Risk of Morbidity and Mortality uncertain

Free? Choice? Collective? Responsibility?

• “Vaccination decisions are made under imperfect information, which means an individual’s assessment of the risks and benefits of vaccination are often inaccurate. But even if individuals had perfect information regarding the cost and benefits of vaccination, the free choice outcome would still be different from the social outcome due to the ‘free rider’ problem associated with vaccination” (Sadique 2006)

Emergency/Urgent Ethical Decision?

• Evidence based decision making requires a non-heuristic cognitive process

• In most urgent settings decision making even by the most well informed is in the final stage an emotional/heuristic decision

• Are ethical discussions most focused in the “retro-spectoscopic setting” except where time, issues and emotion permit a cognitive review and decision making.

• Getting a needle is still often an emotional event, even for the informed and calm.

Vaccination: Pointed Social Dilemma

• “this will only hurt a bit!”• “what is best for your child?”• “it is your professional responsibility”• “the risk of adverse event is one in a million”• “togeather we can eliminate this disease from

the world”• “if he/she had been vaccinated then this

decision to turn off the ventilator would most likely not have to be made”

Public Health: State/National Trust

• “When the state curtails individual freedoms for the collective good, it should address several issues including the magnitude of the individual and community risk, the strength of the individual’s conviction, wider and long-term consequences of restricting individual autonomy, effective risk communication, best available scientific evidence, and transparency of the decision making process”.

(Salmon and Omer: 2006)

Vaccination: Obligation or Privilege?

• Questions/Discussion• Thank you for your participation in the

discussion and evolution of this vital and timely, yet critical issue.