By Yong-Bee Lim, Biodefense PhD Candidate
With events like the COVID-19 pandemic, it is easy to focus solely on the numbers and the devastating impact it has had on the economy and politics. As of November 4th, the World Health Organization (WHO) reported over 48 million cases of COVID-19, resulting in over 1.2 million deaths globally. At over 9.5 million confirmed cases and upwards of 234,000 deaths, the US accounts for nearly 20% of all COVID-19 cases and deaths.
This pandemic also highlighted vulnerabilities in the medical product supply chain. It has significantly hampered the transportation of supplies as some nations have closed their borders in an attempt to get a handle on the spread of COVID-19. In addition, a global dynamic has emerged where demand for personal protective equipment (PPE) has far exceeded domestic and international supplies.
This incident has highlighted clear tensions that exist between the need to cooperate on an international scale and the fundamental need for individual states to prioritize the health and well-being of their citizens. This has had significant impact in areas like pharmaceutical research, development, and distribution – in particular, the issue of distribution raises ethical questions about equitable access to treatment during a global pandemic.
During the 63rd American Biological Safety Association (ABSA) Annual Biosafety and Biosecurity Virtual Conference, a global community of biosafety and biosecurity practitioners and experts convened from November 4 –6, 2020. This conference focused on a broad variety of topics dealing with biosafety, biosecurity, and bioethics with an emphasis on activities related to COVID-19.
Overview of ABSA Virtual Conference Report
I attended this virtual conference along with my GMU Biodefense Program colleagues Ms. Rachel-Paige Casey and Ms. Sally Huang. To provide our readership with a comprehensive report on the ABSA conference, we self-assigned sessions that we would write about. This report provides an overview, details, and comments on the following sessions:
- Session IV: Decontamination Panel
- Session V: Bioethics and Biosafety Panel
- Session VII: Outreach and Training
- Session X: Coronavirus Inactivation and Challenges in Coronavirus Vaccine R&D
Session IV: Decontamination Panel
As COVID-19 continues to rage throughout the United States, healthcare facilities need solutions to supply chain issues. One option it to try and acquire new supplies of PPE gear. Unfortunately, global supply chain issues and the rise of counterfeit and mis-advertised products pose significant challenges to this option.
The other option is to find ways to repurpose used PPE. For healthcare facilities, this option offers the advantages of availability and minimal transport compared to procuring new PPE. However, the major obstacle for this option is researching, developing, and testing PPE decontamination protocols in real time.
The decontamination panel consisted of Drs. Antony Schwartz (Duke University), Andrea Vogel (National Institutes of Health [NIH]), and Brian O’Shea (Battelle). These experts discussed three different PPE decontamination efforts during the on-going COVID-19 pandemic – the research and development of two different protocols using hydrogen peroxide vapor to decontaminate and reuse N95 respirators and powered air-purifying respirators (PAPRs), as well as Battelle’s development of a vapor phase hydrogen peroxide technology to accomplish the same goals.
Each panelist described the research, development, and protocol calibration of decontaminating and reusing PPE as difficult. Unexpected challenges arose as groups tried to develop successful protocols for reusing PPE. A common thread across the three presentations included dealing with PPE soiled with makeup – in all three decontamination efforts, masks soiled with makeup were taken out of the decontamination and reuse rotation to err on the side of caution. In addition, each panelist described logistical obstacles they had to overcome to scale their decontamination efforts to meet the demand of reusable PPE – this meant finding and using large, dedicated spaces with temperature, environmental, and vaporized hydrogen peroxide release controls, as well as developing special racks and hangers to allow for proper PPE decontamination and drying. A third major challenge to overcome was efficacy – proving that the masks had both been decontaminated and had not degraded in performance.
Despite these obstacles, each panelist pointed towards clear evidence of success. Dr. Vogel noted in her section that over 38,000 N95 masks had successfully been reprocessed, Dr. Schwartz discussed how his project’s protocol have repurposed over 10,000 N95 masks and a significant quantity of PAPRs, and Dr. O’Shea pointed to how Battelle’s overcame logistical obstacles to help address PPE shortages through its network of over 60 Critical Care Decontamination System sites across the United States.
Session V: Bioethics and Biosafety Panel
ABSA traditionally considers itself as an organization that focuses on biosafety and biosecurity, which is apparent in the title of this conference: 63rd Annual Biosafety and Biosecurity Virtual Conference. However, with this year’s heavy emphasis on COVID-19 issues, it is impossible to talk about addressing COVID-19-related issues without having a conversation about incorporating at least one session on bioethics – the study of ethical issues, framing paradigms, and implications due to advances in areas like medicine and the life sciences.
The bioethics panel consisted of Drs. Stefen Wagner (Biorisk International) and Brynn Welch (University of Alabama, Birmingham). Dr. Wagner provided a brief overview of the foundations of bioethics a field whose guiding principles consist of four main considerations, or “pillars”: nonmaleficence, justice, beneficence, and autonomy.
Dr. Wagner described two examples of bioethics that were salient to both the ABSA audience and modern dilemmas. The first example involved popular commercial genetic testing kits and databases like those of 23andMe and Ancestry.com. While people have used these commercial tests to discover their potential historic ancestry based off their DNA, Dr. Wagner noted that there are implications to companies having such unique, personalized data at their disposal. His second example involved a recent COVID-19-related hot topic: the efficacy and desirability of so-called “immunity passports.” Immunity passports are a framework that would allow those previously infected with COVID (and thus, hopefully, immune) to travel, work, and interact with others as they had before the pandemic. In regard to immunity, he noted that exposure to COVID-19 results in higher IgG and IgM antibodies against the virus, which means it is quite likely that the body is primed to address COVID-19 and provide at least some degree of immunity. The caveat he offers is that the efficacy and longevity of immunity remain in question, and scientists can only find that out with more research over the years to come. Dr. Wagner raised a number of points about how effective such a framework would be, as well as raising the question of unintended consequences – given the desirability of immunity passports, what is the extent to which people may deliberately infect themselves, commit fraud and theft, and even use immunity passports as a way to discriminate against others?
Dr. Welch then presented on a hot topic at the intersection of bioethics and COVID-19: the bioethics of COVID-19 vaccine trials. During her presentation, she reiterated that she understood both the need and the desirability of finding a vaccine for COVID-19. However, she also wanted to raise points about how an accelerated COVID-19 vaccine may not be in the best interest of the rights of individuals, communities, and society.
Dr. Welch discussed four main issues that she saw regarding the bioethics of COVID-19 vaccine research and development. First, she expressed concern that individuals may be feeling social and biological coercion to participate in vaccine trials, which can meaningfully undermine a person’s autonomy. Second, she discussed the difficulties of truly communicating risks to test subjects, which raises questions about how informed participants can be when giving consent. Third, she noted that test participants may not be getting adequate compensation in drug trials, or that attractive compensations may skew the pool of participants to those with greater financial needs. Finally, she brought all her former considerations together to ask how practitioners can balance the welfare of research subjects against life-saving and economy-saving scientific research.
Session VII: Outreach and Training
Even prior to the pandemic, ABSA members were engaging in outreach and training to new audiences participating in the life sciences. This partially has to do with the expansion of the life sciences research and practices outside of academia, industry, and government as highlighted by groups such as the Do-It-Yourself Biology (DIYBio) movement. In addition, biosafety experts have realized that students, faculty, and staff may have to deal with potentially infectious materials during their work and everyday lives.
The outreach and training panel consisted of Ms. Irene Mendoza (Arizona State University, Tempe), Ms. Janelle Runberg (Northern Arizona University, Flagstaff), and Dr. Muhammed Karahan (Pendik Veterinary Control Institute, Istanbul, Turkey). Each of the panelists discussed unique outreach and training initiatives to make their respective communities and institutions a safer space from a biosafety perspective.
Ms. Mendoza presented on three main activities she helped organize and facilitate to promote outreach and training. First, she discussed an initiative called the “Eye Promise Campaign” – an effort to promote a culture of safety at ASU by setting expectations for those doing work that require safety glasses. This “Eye Promise Campaign” included flyers, presentations, and hands-on activities like “Blinging for Safety,” where prescription safety glasses were provided at no cost for individuals to decorate and use during their lab work. The second initiative she discussed was the Arizona State University (ASU) Open Door event, where ASU invites local community members to visit and explore any of the 5 ASU campus locations. Free and open to the public, the ASU Open Door event also includes hands-on biosafety and biosecurity activities at booths and labs in conjunction with FBI partners, including “Ask an FBI Agent,” “Bio Bistro,” “Lab Made Foods,” and “A Biosecurity Investigation.” She then discussed a STEM initiative for students in grades 6 – 12 called the “Chief Science Officers” program, where students participate in leadership training sessions, attend meetings with local business and civic leaders, and receive direct mentorship.
Ms. Runberg’s work in outreach and training was driven by both her passion for biosafety and a desire to ensure that safety is an integral part of the learning and working environment at Northern Arizona University (NAU). To this end, she helped improve biosafety pre-COVID by rolling out an online training and hazard management system called “BioRAFT,” expanding the aperture of biosafety messaging and training to students and faculty that may have interactions with sharps (which include items like needles, scalpels, and other sharp objects), and increasing in-person training frequency and direct outreach to different departments at NAU. While COVID presented significant challenges to the direct availability of a biosafety person for training, Ms. Runberg generated training videos and presentations that she self-created to continue educating others in a socially distanced fashion.
Dr. Karahan’s presentation focused on finding ways to minimize biosafety risk for individuals that visited Pendik Veterinary Control Institute – a veterinary research institute in Istanbul, Turkey, which includes one BSL-3 laboratory out of 21 labs total. This government laboratory operates with 188 trained employees, but also has a guesthouse on campus where visitors can stay. Dr. Karahan discussed how those that often stayed in the guesthouse were typically unaware of the potential risk from the institute. To fill this gap, the institute obtained permissions from the government to develop and provide a set of emergency procedures for guesthouse visitors. Guesthouse visitors were given pre- and post-survey evaluations to test the efficacy of knowledge transfer and retention during their visit, with Dr. Karahan reporting that the surveys indicated that guests gained awareness and retained emergency procedures over the course of their stay.
Session X: Coronavirus Inactivation and Challenges in Coronavirus Vaccine R&D
Many countries around the world have experienced varying success with the different ways they have approached COVID-19 in terms of preparedness, response, and mitigation. One key element that exists across all countries is the importance of developing an effective vaccine. To this end, it is important to understand how viruses like COVID-19 can be inactivated and studied for the research and development of vaccines.
This panel consisted of Mr. Cary Retterer (ABL, Inc.) and Dr. Daniel Eisenman (Advarra). Mr. Retterer’s talk focused on developing and confirming protocols for viral inactivation in different conditions – from cell monolayers and tissue samples to concentrated virus stock and sera. After a detailed description of the protocol and results, Mr. Retterer discussed the challenges associated with consistent and effective viral inactivation. He noted that inactivation testing is resource intensive. In addition, he stated that filters tended to clog and interrupt the process, particularly for larger samples like tissue samples. Third, he noted that in vivo samples were particularly challenging to accommodate for viral inactivation. And finally, he provided a recommendation for a harmonized, pan-institute repository of inactivation methods that could leverage industry-wide experience and expertise, as well as minimizing the number of animal specimens that may then be required for inactivation testing.
Dr. Eisenman then presented on the major trends in scientific advances in clinical trials involving gene therapy and gene-modified cellular therapy. Dr. Eisenman has a unique vantagepoint on this topic as he has participated in providing institutional review board (IRB) oversight for 100% of Operation Warp Speed’s (OWS) COVID-19 vaccine trials as an employee of Advarra. In his discussion of Coronavirus vaccine R&D, he explained the basics of how vaccines work, as well as how all the vaccine research groups are utilizing some form of recombinant or synthetic nucleic molecules. While he noted the promise of these types of gene therapy approaches to future vaccine and treatment development, he also highlighted how these approaches can pose unique challenges in conducting future risk assessments in this area. A few issues practitioners will need to consider with gene therapeutic approaches are the genetic modifications that are occurring (to the vector, to the antigen, and the potential risk of recombination), the implications of viral shedding with gene-modified products, and the unique risks that may be involved with at-risk populations that may interact with study participants.
Necessity is the Mother of Invention – A Woven Thread
Each panel incorporated presentations and discussions about the challenges that COVID-19 has presented to operating safely, securely, and ethically in the life sciences. The pandemic has made resources scarce, in-person collaboration and outreach virtually impossible, and raised many questions on what the best approach is to bring about the end of the pandemic.
What this conference has shown is that necessity is the mother of invention. Each of these panels highlighted how innovation can happen in the face of adversity. Supply chain failures helped generate robust and sustainable PPE decontamination and reuse models in different settings. Incorporating bioethics in a time of great societal instability and erosion of trust in the institution of science is the first step in building a collective vision of what is and is not acceptable as we try to move to a post-COVID era. The inability to convene did not stop biosafety outreach efforts to teach other safety professionals and the broader community about how to handle and dispose of sharp objects, as well as how to properly don and doff PPE. Finally, while OWS was not the funder of the most promising therapeutic researched and developed by Pfizer, it has served as a demonstration of a moonshot challenge that may enable vaccines to be researched, developed, and deployed significantly more quickly than the typical 10 – 15-year timeline.