Bioethics in Practice: The Bioethics of Developing a COVID-19 Vaccine From Vaccine Trials to Distribution – The Commentator

As the novel coronavirus, SARS-CoV-2, continues to rapidly spread around the globe, scientists and researchers have been rushing to develop a vaccine to halt this deadly pandemic. With over 38 million cases and one million deaths worldwide, the need to create a safe and effective coronavirus vaccine as quickly as possible is of utmost importance. While vaccines ordinarily take 10 to 15 years to develop and bring to market, researchers hope to have this vaccine ready for distribution in far less time than any vaccine previously made. However, under the pressure to create this extremely complex vaccine in such a short time span, it is important not to lose sight of the numerous bioethical challenges researchers must overcome in creating this vaccine.

Developing a vaccine is a complex process which is made up of a series of carefully planned stages. Of these stages, perhaps the most significant is the clinical development stage, where three recurring phases of vaccine trials on human subjects of increasing sample size are conducted. Due to the large number and diversity of individuals affected by COVID-19, one of the greatest bioethical challenges to be overcome in vaccine trials is making sure that individuals of all ages, genders and ethnicities are properly represented among vaccine trial participants. This strong need for diversity in the vaccine trial samples is vital in ultimately ensuring that the vaccine will be effective in vaccinating the maximum number of individuals across all demographics. Yet, despite the numerous federal guidelines in place to establish diversity in vaccine trials, recent studies suggest that many of the coronavirus vaccine candidates currently in development lack this necessary diversity.

The population most at risk for complications and death by COVID-19 are elderly individuals, with those above the age of 65 comprising over 80% of COVID-19 deaths. And yet, numerous studies suggest that COVID-19 vaccine trials lack an adequate representation of elderly participants. One such study published in JAMA Internal Medicine on Sept. 28, 2020, found that elderly people were excluded from more than 50% of COVID-19 clinical trials and 100% of vaccine trials. One possible explanation for the exclusion of elderly study participants could be that their inclusion in coronavirus vaccine trials is itself a controversial bioethical issue, with many arguing that elderly individuals should not be included due to the increased health risks they may face from participating in these trials. However, others contend that the inclusion of healthy elderly individuals in these trials is necessary to ensure that the vaccine will be effective in this more vulnerable population.

In addition to a lack of elderly participants in COVID-19 vaccine trials, studies also suggest that there is insufficient representation of ethnic minorities in many vaccine trials in the United States. According to the CDC, Hispanic and Black Americans comprise a disproportionately large number of COVID-19 cases and are nearly twice as likely to die from COVID-19 complications than their white, non-Hispanic American counterparts. Despite this, many vaccine trials failed to obtain a representative sample of these minorities, particularly in the earlier vaccine trial phases of many of the vaccine candidates currently under development.

Ensuring that the sample of participants tested in COVID-19 vaccine trials accurately represents the population of individuals affected by COVID-19 is a highly significant bioethical issue, as having this diversity in vaccine trials ensures that all individuals affected by this virus, regardless of demographics, can look forward to equal benefits from this vaccine. Fortunately, measures are being taken to improve the diversity of COVID-19 vaccine trials going forward.

Equity in the development of a vaccine for COVID-19 is one bioethical concern; equity in the distribution of that vaccine is of equal importance. Once a COVID-19 vaccine is deemed safe and effective, the vaccine will need to be distributed on both a national and international level. On a national level, due to the limited number of vaccines that can be produced at a time, some groups of people will be prioritized in receiving the vaccine over others. The CDC recently released its plan for COVID-19 vaccine distribution, stating that first responders, health care workers, those with underlying health conditions, elderly individuals and essential workers will be prioritized in vaccine distribution. This decision on which populations to prioritize is a delicate bioethical issue, with the ultimate goal being to maximize the number of lives saved.

On an international level of vaccine distribution, perhaps the most significant bioethical challenge to be dealt with will be ensuring equal access to COVID-19 vaccines by all individuals, regardless of demographics, such as socioeconomic status or geographic location. There are currently several existing proposals on how to ethically distribute COVID-19 vaccines globally, all of which seek to establish a system through which individuals in poorer, less developed countries will have equal access to vaccines, though the majority of these proposals tend to inadvertently prioritize wealthier, more developed countries.

Developing and distributing a COVID-19 vaccine will involve overcoming a multitude of unique and complex bioethical challenges, from making sure that COVID-19 vaccine trials contain samples representative of the large, diverse populations of individuals affected by COVID-19, to ensuring that COVID-19 vaccines are allocated fairly and equitably to individuals of all demographics. COVID-19 has united individuals of all ages, ethnicities, and socioeconomic statuses across the globe through mutual feelings of fear, grief, and uncertainty; we can only hope that all of these individuals around the world will have an equal opportunity to once again be united, but this time, finding solidarity in the mutual feelings of hope and relief that an ethically designed and fairly distributed COVID-19 vaccine will bring.

Photo Caption: Scientists and researchers have been rushing to develop a vaccine to halt this deadly pandemic.Photo Credit: Pixabay

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Bioethics in Practice: The Bioethics of Developing a COVID-19 Vaccine From Vaccine Trials to Distribution - The Commentator