Tuesday, August 25, 2020

Ethics and Vaccine Development

Linda Hogan, Trinity College Dublin

We have all seen the devastation that COVID-19 has wrought on lives and livelihoods, and while the extreme lockdown measures have eased in many jurisdictions, the medium-term challenges of living with the virus are only now being properly understood.  The complexities involved in balancing individual autonomy with the common good, or public health with economic wellbeing are debated daily across all media platforms.  The greatest hope for the resumption of social, cultural and economic activity lies in the development of an effective vaccine and the commitment to deliver it to populations across the world.  

Hope that an effective and safe vaccine will soon be developed is high and the public appetite for up-to-date knowledge about progress is strong.  In addition to the technical updates in scientific journals, more popular venues, such as the Guardian and the New York Times keep the public informed about the various vaccine candidates (135+) and their relative stages of development from the pre-clinical stage to approval.  Rarely has scientific investigation and discovery been conducted under such public scrutiny or in such a contested political climate.   In this context of heightened interest and pressure for success, ethics has a critical role to play.  Moreover, when understood as a partner of the scientific disciplines it can assist by assuring the integrity of the scientific process, building confidence in the safety and efficacy of the vaccine and ultimately promoting public trust in science.

COVID-19 vaccine development involves research on human subjects, a field that is already carefully regulated according to scientific, medical and ethical principles.  The 1964 Declaration of Helsinki (updated 2013) and in Europe the 1997 Oviedo Convention map out the core requirements for ethical research on human subjects.  Respect for the individual frames the entire approach, requiring the full and informed consent of participants and the opportunity to opt out at any stage. The Declaration also insists on the primacy of the subject’s health and welfare, even over scientific advances, as well as on protections of vulnerable subjects.  The Oviedo Convention, whose formal title is the Convention on Human Rights and Biomedicine, is legally binding on its signatories and specifies even more clearly the practical implications of protecting human dignity, without discrimination in biomedical research. 

There is now a strongly embedded culture of ethical biomedical research leading to therapeutic interventions, including vaccines, and this is the context in which COVID-19 vaccine development takes place.  However, the relentless pace of COVID infections and deaths has created pressure to shorten the timeframe for vaccine development, through the use of challenge trials, namely trials that deliberately infect healthy subjects with COVID-19 after giving them vaccine candidates.  Challenge trials are controversial, though not unusual in the history of drug and vaccine development.  They often used prisoners, psychiatric patients, people living in poverty, that is, individuals from whom consent could be obtained because of their vulnerability.  Indeed, this was not unique to scientific research but rather was part and parcel of a more general societal disregard for these populations.  However, there are now strong protections for vulnerable subjects so this risk is mitigated to a certain extent, although Jill Fisher’s Adverse Events: Race, Inequality and the Testing of New Pharmaceuticals tells a more sobering tale.

Therefore, accepting that vulnerable subjects would be excluded, is it morally acceptable to infect healthy, willing subjects with a potentially deadly virus for which there is no treatment?   There are strong arguments against these trials.  There is significant risk of harm or death. The beneficient outcome of an effective vaccine may be unrealized. Genuine, free consent may not be possible, particularly if there is societal pressure for altruism, even extreme altruism, as proposed by Julian Savulescu and Dominic Wilkinson. Notwithstanding these difficulties, it is possible to construct an ethical framework for challenge trials in specific and limited circumstances.  Indeed the World Health Organisation has already published scientific and ethical criteria that would underpin ethically acceptable challenge trials for COVID-19 vaccines and has more recently published a roadmap for their implementation.  In addition to the high scientific bar, the WHO guidelines also map out an elevated threshold of independent ethical and public review.  This requirement incorporates the principles of PPI (public patient involvement) in the design as well as the implementation of the trials, thereby enhancing the agency of volunteer participants.  The WHO guidelines require participants to be young and in good health, thus excluding the elderly with altruistic motives who may feel societal pressure to participate.  They also include rigorous assessment of the informed consent process as well as the obligation to provide excellent medical care to participants.  Although the WHO has not, as yet, endorsed the use of challenge trials for COVID-19 vaccine candidates, the guidelines create a robust roadmap for the ethical use of challenge trials in these unique circumstances.

Vaccine development is laden with scientific and ethical challenges, and these challenges are amplified in the fraught and contested political climate of 2020.  Nonetheless we are presented with a unique opportunity to demonstrate that scientific advancement and ethical research are partners, not rivals, in the search for a safe and effective vaccine for COVID-19.

Linda Hogan is Professor of Ecumenics, Trinity College, Dublin.

Suggested citation: Linda Hogan, ‘Ethics and Vaccine Development’ COVID-19 Law and Human Rights Observatory Blog (25 August 2020)  https://tcdlaw.blogspot.com/2020/08/ethics-and-vaccine-development.html

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