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COVID-19 vaccine research and the trouble with clinical equipoise argues that “a more fine-grained analysis of clinical equipoise is needed to account for cases in which uncertainty in the medical community exists for some outcomes [of COVID-19 research] and not for others,” in Lancet, February 2021 |
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A Politics-free Path to a COVID-19 Vaccine outlined by Physicians for Human Rights Advisory Council members, October 30, 2020 |
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Ethics of Placebo Controls in Coronavirus Vaccine Trials, by Franklin G. Miller, who argues that even after some vaccines receive Emergency Use Authorization by the FDA, it will remain ethical to enroll participants in other coronavirus trials that randomize half of them to a placebo, October 27, 2020 |
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Fair Compensation for Rare [COVID-19] Vaccine Harms, by Art Caplan and Dorit Reiss, advocates expansion of the National Childhood Vaccine Injury Compensation Program, rather than limiting manufacturers’ liability and providing claimants compensation under the Public Readiness and Emergency Preparedness Act, September 9, 2020 |
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How the race for a Covid-19 vaccine is getting dirty by Laura Spinney, author of Pale Rider: The Spanish Flu of 1918 and How It Changed the World, reports on global competition to develop a COVID-19 vaccine, The Guardian, August 30, 2020 |
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In Pregnant Women in Trials of Covid-19: A Critical Time to Consider Ethical Frameworks of Inclusion in Clinical Trials Ruth Farrell, Marsha Michie, and Rachel Pope argue that the pandemic demands reconsidering inclusion of pregnant women in treatment and vaccine trials, July 2020 |
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Center faculty member Alex John London was quoted in We can’t skip steps on the road to a COVID-19 vaccine, arguing that emergency conditions should be allowed to rush vaccine research and undermine rigorous scientific standards, The Verge, August 4, 2020 |
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Researchers Debate Infecting People on Purpose to Test Coronavirus Vaccines; bioethicists Art Caplan (NYU) and Jeff Kahn (Johns Hopkins) comment on the ethics of human challenge trials for a COVID-19 vaccine, New York Times, July 7, 2020 |
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Decades-Old Soviet Studies Hint at Coronavirus Strategy reports on the potential repurposing of polio vaccine to confer protection against the coronavirus, and ethical considerations associated with testing such repurposing, New York Times, June 25, 2020 |
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Can a Vaccine for Covid-19 Be Developed in Record Time?—a discussion moderated by Siddhartha Mukherjee, New York Times Magazine, June 14, 2020 |
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Human Challenge Studies for Covid-19 Vaccine: Questions about Benefits and Risks, by Ruth Macklin, concludes that it is ethically unjustifiable to begin human challenge trials for a COVID-19 vaccine, a “grave disease lacking an effective treatment,” June 15, 2020 |
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Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure argues that by accelerating vaccine evaluation, such studies could reduce the global burden of coronavirus-related mortality and morbidity, and that volunteers could autonomously authorize the risks to themselves and such risks could be acceptable under particular conditions and eligibility criteria, March 31, 2020 |
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What risks should be permissible in controlled human infection model studies? evaluates proposals for different risk thresholds for human challenge studies, March 1, 2020 |
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Challenge studies of human volunteers: ethical issues argues that such studies are not necessarily unethical, but that the level of risk is critical to ethical assessment of them, 2004 |
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In Compensation for cures: Why we should pay a premium for participation in ‘challenge studies’ Jonathan Anomaly and Julian Savulescu argue that standard worries about paying for participation in risky research, including challenge studies, are reducible to concerns that can be addressed with appropriate screening mechanisms, 2018 |
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The Road to Immunity During COVID-19 — Developing and Distributing a Vaccine—From the American Public Health Association and the National Academy of Medicine, this recorded panel discussion outlines types of vaccines and process of their development and testing, with attention to the manufacture and supply chain, as well as challenges of distribution of what will be an initially short supply of vaccines against COVID-19 (recorded June 10, 2020, posted with video and transcript) |
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Addressing the Coronavirus Challenge, and hour-long talk describing the process of creating vaccines against a previously unknown virus, by Michael Farzan, PhD, Professor and Co-Chair of the Department of Immunology and Microbiology at Scripps Research, April 22, 2020, with the talk beginning at minute 6:14 |
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What risks should be permissible in controlled human infection model studies?—Most agree that controlled human infection model (CHIM) studies deliberately infecting volunteers with pathogens “should be permissible in some circumstances.” Some endorse establishing risk thresholds to protect research participants from the risks of deliberate infection and to maintain public trust, but whether and why risk thresholds are justifiable have not been addressed in great detail. This 2020 paper argues “that there is no clear reason to develop a risk threshold uniquely for CHIM studies” and suggests “that the same constraints that should apply to the risks of non‐therapeutic procedures in other research designs, involving competent, healthy, fully informed adults, should also be invoked for CHIM studies” |
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The ethical challenge of infection-inducing challenge experiments—by Franklin G. Miller and Christine Grady, writing in Clinical Infectious Diseases in 2001, offer a framework for evaluating the ethical acceptability of infection-inducing challenge experiments that focuses on their “scientific and public health rationale …, the risks that they pose …, the symptoms experienced by healthy volunteers …, the exclusion of vulnerable research subjects, the informed consent process, the payment of volunteers, and the use of isolation of volunteers to prevent infection of others” |
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In 2017, an ethics panel convened by the National Institute of Allergy and Infectious Diseases and the Walter Reed Army Institute of Research published its recommendations regarding a proposal to conduct a controlled infection study in healthy human volunteers to develop a vaccine against the Zika virus. Ethical Considerations for Zika Virus Human Challenge Trials contains considerations pertinent to development of a vaccine for COVID-19 |
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Ebola vaccine development plan: ethics, concerns and proposed measures—Of particular relevance for this pandemic is this paper’s discussion of whether healthcare workers should be prioritized for vaccine research, as well as the need to counter misinformation in order to facilitate research on a vaccine |
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Vaccine testing for emerging infections: the case for individual randomization—Focusing on the 2014-2015 Ebola outbreak, authors Nir Eyal and Marc Lipsitch discuss the debate about using individually randomized controlled trials (iRCTs) to test candidate Ebola vaccines, a debate that centered on “statistical efficiency, logistical feasibility and public acceptability,” as well as ethical concerns. They make an ethical case for employing iRCTs based on benefits to non-participants, post-trial benefits to participants (including post-trial access to the study intervention), participants’ prospects before randomization, and the near-inevitable disparity between arms in any RCT |
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Are placebo controls necessary in controlled human infection trials for vaccines?—The authors of this 2020 Personal Viewpoint article in The Lancet review considerations supporting the view that data from past studies (historical data) could be used as a valid alternative to a placebo control group |
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"We are the heroes because we are ready to die for this country”: Participants' decision-making and grounded ethics in an Ebola vaccine clinical trial—This 2018 paper in Social Science and Medicine reports participant motivations for volunteering for a vaccine trial, in spite of anxieties, rumors and mistrust surrounding the Ebola outbreak |
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Ethics and pre-exposure prophylaxis for HIV infection—Although this article focuses on ethical challenges of testing the effectiveness of PrEP in preventing HIV infection, there are relevant parallels to be drawn for testing of a COVID-19 vaccine, because while “providing preventive modalities besides what is being tested in the trial … may protect participants, it may also undermine the ability of the trial to answer the research question at hand” |
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Microneedle array delivered recombinant coronavirus vaccines: Immunogenicity and rapid translational development—EbioMedicine publication reporting promising vaccine research, tested in mice, by the University of Pittsburgh (with Erasmus Medical Center Rotterdam), April 1, 2020 |
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Coronavirus (COVID-19) Update: Vaccines and Immunity—JAMA audio interview with Mayo Vaccine Research Group Director Gregory Poland, MD, who discusses antibody responses, duration of immunity, vaccine safety, and the prospects for using convalescent serum to passively immunize people unexposed to SARS-CoV-2 |
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Making Emergency Use of Experimental Vaccines Safer (2020)—Reflecting on the Ebola epidemic, the authors analyze challenges of deploying experimental vaccines and present recommendations of the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group |
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Guidance for Managing Ethical Issues in Infectious Disease Outbreaks (2016), World Health Organization—“Research is an integral part of the public health response—not only to learn about the current epidemic but also to build an evidence base for future epidemics. Research during an epidemic ranges from epidemiological and socio-behavioral to clinical trials and toxicity studies, all of which are crucial” |
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Ethical Considerations of Experimental Interventions in the Ebola Outbreak (2014)—Reflecting on the Ebola epidemic, Rid and Emanuel argue that “experimental Ebola treatments or vaccines should only be deployed in clinical trials. If trials are done, they must meet the eight ethical principles for research” |
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Ethics and Etiquette in an Emergency Vaccine Trial. The Orchestration of Compliance (2020)—cautioning readers about generalizing from the Ebola vaccine trial reported, the author analyzes “the practices that contributed to very high compliance rates [in an Ebola vaccine trial]. … This analysis uses the notion of bioetiquette—the set of rules specifying “proper” and “improper” trial subjects and behaviours—which runs in the shadow of formal bioethics in trials and requires careful transdisciplinary examination” |
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Infectious Disease Research and Dual-Use Risk (2006)—presents general recommendations to address the dual-use risk presented by vaccine and treatment research on infectious |
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Ethics Review of Studies during Public Health Emergencies: The Experience of the WHO Ethics Review Committee during the Ebola Virus Disease Epidemic (2017)—Based on a review of 24 new and 22 amended protocols for studies reviewed by the WHO ethics review committee during the Ebola epidemic, including vaccine and drugs trials, the authors make 8 recommendations to accelerate study approval in future public health emergencies |
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Ethical considerations in post-market-approval monitoring and regulation of vaccines—This 2014 paper provides a framework for evaluating post-approval oversight of vaccines to minimize potential harms, including both direct harms to health and indirect harms resulting from withdrawal of vaccines from the market, and concomitant special harms to vulnerable populations |
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The Hastings Center has collected articles from the medical and bioethics literatures regarding COVID-19 vaccine and treatment research |
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The Washington Post offers two, frequently updated primers on vaccines in development and under FDA review: |
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The race for coronavirus vaccines: a graphical guide: Eight ways in which scientists hope to provide immunity to SARS-CoV-2—This graphical guide in Nature explains different vaccine designs |