Introduction:
The outbreak of the Coronavirus towards the onset of 2020 presented many unique challenges for both the citizens and governing bodies of many nations. Within the United States, the coronavirus initiated a nation-wide lockdown, mask mandates, occupancy limitations in public areas, and a "push" for pharmaceutical drug developers, scientists, and other medical institutions to find a vaccine to help combat this international pandemic.
The first vaccines made available to the public were released in December of 2020, including Johnson & Johnson, Pfizer BioNTech, and Moderna [1]. Frontline workers and the elderly were amongst the first to receive these varieties of coronavirus vaccines. However, the release of COVID-19 vaccines endured much skepticism from the American public. According to a research survey issued by the Kaiser Family Foundation (KFF) in 2020, a quarter of U.S participants were still “vaccine hesitant” despite an increase in those willing to receive the vaccine under the same circumstances [2]. One theory for such hesitancy among Americans I deduced from both survey reports and my own personal conversations with others: the vaccines are speculated amongst the public to have circumvented certain procedural and testing requirements set forth by the FDA and CDC due to the speed at which they were produced.
In this paper, I hope to explore this theory by interviewing individuals of different age groups about their decisions to receive the COVID-19 vaccine. Following the interview synopsis, I will briefly discuss how and when the FDA decides to expedite the production and use of biologics (in this case the COVID-19 vaccine). I will also weigh in on how I believe this decision is highly based on the delicate balance between beneficence and maleficence in clinical research and drug development.
I am aware that my interview pool is limited in size due to travel restrictions, technological inadequacies, time constraints, and other unforeseen circumstances. I acknowledge that I carry bias concerning the coronavirus vaccine as a caretaker and relative of those who are older and/or immuno- compromised due to a medical condition.
Interviews:
In order to gauge the repercussions of having a seemingly expedited vaccine released to the public, I asked the interviewees questions concerning when they received their first vaccine (if at all) and why they decided to receive it at that time instead of in January or February of 2021.
All of those who agreed to be interviewed identified as Black/African American. The interview age group ranged from twenty to sixty years old.
Although there were variations in age, household count, and health insurance coverage status, all interviewers expressed a high level of uneasiness during the debut of the coronavirus vaccine in December of 2020. As stated by one of the interviewees, the vaccines seemed to have “shown up as quickly as the [corona] virus did” in relation to the start of the national lockdown in March of the same year. The earliest date any of those interviewed received their first round of vaccines was recorded to be in March of 2021, a year after lockdown in the U.S began and 3 months after the first COVID vaccine was made available to the public. The level of distrust seemed to be exponentially higher with the Johnson & Johnson vaccine over Pfizer and Moderna. There was not a clear correlation between these worries and the Johnson vaccine outside of the fact that the Johnson vaccine only required a single dose, perhaps suggesting weaker immunity as compared to the other double-dose vaccines.
In terms of reasons for delaying getting a vaccine, the responses were fairly consistent throughout the interviews. Those who were employed from December 2020 on forward (and were not remote workers) stated that their employers encouraged employees to get vaccinated. Some employers offered at most a full day of paid time off for employees to receive the vaccine. Interviewees between the ages of 20-29 years old who either were or were not employed after the start of 2021 shared similar reasons for receiving their choice of vaccine. These interviewees in particular expressed that the "push" to get vaccinated came from older family members and friends.
This scenario was the case with my family and I as I was not too keen about getting vaccinated in the beginning. I would best describe my feelings as feeling like "a human guinea pig" for the vaccine as its long-term side effects were practically unknown. After experiencing an onslaught of acute symptoms, I tested positive for COVID in September of 2020 and was quarantined for 2 weeks thereafter. I was very skeptical about the vaccine prior to it becoming available to the public. I gave thought to the number of different strains of the SARS virus that could exist. Would one vaccine be enough? Could the virus adapt quicker than vaccines could be produced? How much information is known about the virus and its effects on the human body? Given that I have an autoimmune disease, will my immune system be able to cope with an alternative strain if it is different from the inactive form of the virus within the vaccines?
My contact with those outside of my household were still fairly high as I ran errands for household needs at least once a week to every other week. The constant cleaning, sanitizing, and being disinfected every time I left or entered the house for any reason became overwhelming. I eventually got vaccinated along with my family in late-April 2021. Similar to many of the responses I received from the interviews, the pros of being vaccinated and allowed to continue caring for family members outweighed the cons and risks of receiving the vaccine. In all, the apparent race to create and distribute a COVID-19 vaccine may have had an opposite effect and actually deterred the general public from voluntarily wanting to receive the vaccine.
Brief Explanation of FDA Protocol & Beneficence in the Expedition of Vaccines
In the United States, the FDA along with its subset departments (the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) are responsible for the approval and regulation of vaccines [3]. The FDA in conjunction with these departments published a guide for drug development companies concerning the government's biologics expedition programs. For the implementation or public use of a drug or biologic, there are four primary programmed outcomes through which they can receive approval from the FDA if produced to address a serious condition. According to the FDA’s Guidance for Industry Expedited Programs for Serious Conditions, these expedited programs are allotted to companies and researchers whose products contribute to “efforts [addressing] an unmet medical need in the treatment of a serious condition” as defined by the FDA [4]. Submissions made to the FDA under the premise of fulfilling this need require detailed summary as to how the product will be used and what clinical testing has already begun. The FDA in turn evaluates the severity of both the condition and lack of aiding resources available before issuing a final decision.
The severity, acute impact, and prolific spread of the SARS-CoV-2 virus lead to the FDA issuing an expediting protocol known as the Emergency Use Authorization (EUA) protocol. The EUA protocol allows medical treatments to be publically available and used in the case of a public health emergency. Ultimately, the FDA approves the use of “unapproved medical products or unapproved uses of approved medical products” in a public health emergency in order “to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives” [5,4]. Statutory criteria includes the interim or final data collected from phase 3 clinical trials conducted by vaccine manufacturers making the EUA request. The FDA also created a streamlined evaluation process for possible COVID-19 remedies known as the Coronavirus Treatment Acceleration Program (CTAP) in response to the pandemic [6]. For more details explaining the three phases of clinical drug and biologics testing or CTAP, visit the FDA official website or the summary report for COVID-19 provided by CBER (reference works 5 and 6 of this paper) .
The use of an EUA is a primary example of the delicate balance that exists between the bioethical pillars of beneficence and maleficence. In its simplest form, this is the desire to simultaneously cause the most amount of good and the least amount of harm. In order to form a well-informed and unbiased decision for an EUA, the FDA enlists the help of a Vaccines and Related Biological Products Advisory Committee. This committee is composed of a variety of public health and medical professionals who are tasked with taking a comprehensive look at how the proposed product performed on clinical trials and what impact it could have if approved for public use. An essential component of the FDA’s expediting decision-making process is weighing the known and unknown benefits as well as the potential harms of approving and releasing previously unapproved medical vaccines to the general public [5]. With this in mind, the FDA knows that there are inherent risks to be considered when dispensing vaccines, including risk of cross-contaminations and unknown side effects. The manufacturers are required by the FDA to provide data justifying the safety of the vaccine as well as reporting any adverse effects recorded during lab testing and from clinical trial participants. It is evident that the FDA, albeit under pressing circumstances, still requires vaccine manufacturers and researchers to meet the vast majority of biologic testing protocol in order to be considered for any expedited services.
The FDA must also weigh the positive outcomes that could result from expediting vaccine approval. There are also overall positive outcomes to receiving vaccinations, especially antibody production. The vaccination of frontline workers may decrease their risk of lethal consequences when working with patients and decrease the number of hospitalizations from clinically severe COVID symptoms. I believe the FDA considered the benefit of having a promising means of lowering the amount of hospitalizations and deaths related to COVID, along with certain protocols being met, became the driving force for their decision to give EUA access to developing COVID-19 vaccines.
Conclusion:
Given the limited time frame and other constraints, I continue to contemplate the short and long term effects the Coronavirus pandemic had on both clinical ethics and the medical relationship between U.S government agencies and the general public as a whole. As with all medical emergencies, the clinical decisions made on behalf of the FDA were not made without evaluating and accepting a certain level of risk. The FDA’s decision to expedite COVID-19 vaccines could in and of itself be seen as an act of beneficence in that the expedited vaccines were still judged against their unrelenting protocols. Although clinical testing may comparatively be considered on the smaller end as far as participant pools are concerned, the most desirable outcome was to produce and distribute a mass aid to combat the ever climbing death toll attributed to COVID.
The extent to which this decision will affect future protocols addressing acute disease outbreaks is constantly evolving and expands far beyond the scope of my interviews and the parameters of my paper. I believe further analysis of the repercussions of the pandemic and the COVID-19 vaccines would be necessary.
References
[1] American Journal of Managed Care: The Center for BioSimilars. (2021, January 1). A Timeline of COVID-19 Developments in 2020. AJMC. https://www.ajmc.com/view/a-timeline-of-covid19-developments-in-2020.
[2] Hamel,L., Kirzinger,A., Muñana,C., & Brody,M. (2020, December 22). KFF COVID-19 Vaccine Monitor: December 2020. KFF. https://www.kff.org/coronavirus-covid-19/report/kff-covid-19-vaccine-monitor-december-2020/.
[3] Centers for Disease Control and Prevention. (2014, May 1). Vaccine Testing and Approval Process. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/basics/test-approve.html.
[4] U.S Department of Human Services Food and Drug Administration. (2014). Guidance for Industry: Expedited Programs for Serious Conditions- Drugs and Biologics [White Paper]. FDA. https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf&ved=2ahUKEwie5dOI_urxAhXOJt8KHYRECToQFjACegQIHRAC&usg=AOvVaw1GMSmCJjvYB89U1Q7IFA1D
[5] Center for Biologics Evaluation and Research. (n.d.). Emergency Use Authorization for Vaccines Explained. U.S. Food and Drug Administration. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained.
[6] Center for Drug Evaluation and Research. (n.d.). Coronavirus Treatment Acceleration Program (CTAP). U.S. Food and Drug Administration. https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap#intro.
https://www.ajmc.com/view/a-timeline-of-covid19-developments-in-2020
https://www.kff.org/coronavirus-covid-19/report/kff-covid-19-vaccine-monitor-december-2020/
https://www.cdc.gov/vaccines/basics/test-approve.html
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap