ReviewVaccine2020
So much at stake: Ethical tradeoffs in accelerating SARSCoV-2 vaccine development.
Review in Vaccine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed.
- The next phase in Long COVID research: addressing the ethical challenges in trials of disease-modifying treatments.EClinicalMedicine · 2026Review
- Participant motivators and perceptions of risks and benefits in adult Phase 2/3 COVID-19 vaccine clinical trials.Human vaccines & immunotherapeutics · 2025Article
- Ethical Implications of Artificial Intelligence in Vaccine Equity: Protocol for Exploring Vaccine Distribution Planning and Scheduling in Pandemics in Low- and Middle-Income Countries.JMIR research protocols · 2025Article
- A risk science perspective on vaccines.Risk analysis : an official publication of the Society for Risk Analysis · 2024Article
- Risk, benefit, and social value in Covid-19 human challenge studies: pandemic decision making in historical context.Monash bioethics review · 2022Article
- Do coronavirus vaccine challenge trials have a distinctive generalisability problem?Journal of medical ethics · 2022Article
- Racial and Ethnic Diversity in SARS-CoV-2 Vaccine Clinical Trials Conducted in the United States.Vaccines · 2022Review
- Replacing vaccine paper package inserts: a multi-country questionnaire study on the acceptability of an electronic replacement in different target groups.BMC public health · 2022Article
- Physicians' opinions on the necessity of COVID-19 vaccination in patients with epilepsy.Epileptic disorders : international epilepsy journal with videotape · 2021Article
- Testing SARS-CoV-2 vaccine efficacy through deliberate natural viral exposure.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2021Review
- Ethical tradeoffs in SARS-CoV-2 vaccine development: Assuring fair availability for low-income countries.Vaccine · 2021Article
- Article
- Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials.JAMA network open · 2021Review
- Opinion: For now, it's unethical to use human challenge studies for SARS-CoV-2 vaccine development.Proceedings of the National Academy of Sciences of the United States of America · 2020Article
- Public Willingness to Participate in COVID-19 Vaccine Clinical Trials: A Study from Jordan.Patient preference and adherence · 2020Article
- Should nurses take a COVID-19 vaccine?Nursing outlookArticle
- Controlled Human Infection to Speed Up SARS-CoV-2 Vaccine Development.Frontiers in immunologyArticle
Corrections and comments
- Commented on by
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA sense of urgency exists to develop vaccines against SARS CoV-2, responsible for numerous global cases and deaths, as well as widespread social and economic disruption. Multiple approaches have been proposed to speed up vaccine development, including accelerated randomized controlled trials (RCT), controlled human challenge trials (CHI), and wide distribution through an emergency use authorization after collecting initial data. There is a need to examine how best to accelerate vaccine development in the setting of a pandemic, without compromising ethical and scientific norms.
methodsTrade-offs in scientific and social value between generating reliable evidence about safety and efficacy while promoting rapid vaccine availability are examined along five ethically relevant dimensions: (1) confidence in and generalizability of data, (2) feasibility, (3) speed and cost, (4) participant risks, and (5) social risks.
resultsAccelerated individually randomized RCTs permit expeditious evaluation of vaccine candidates using established methods, expertise, and infrastructure. RCTs are more likely than other approaches to be feasible, increase speed and reduce cost, and generate reliable data about safety and efficacy without significantly increasing risks to participants or undermining societal trust.
conclusionEthical analysis suggests that accelerated RCTs are the best approach to accelerating vaccine development in a pandemic, and more likely than other approaches to enhance social value without compromising ethics or science. RCTs can expeditiously collect rigorous data about vaccine safety and efficacy. Innovative and flexible designs and implementation strategies to respond to shifting incidence and test vaccine candidates in parallel or sequentially would add value, as will coordinated data sharing across vaccine trials. CHI studies may be an important complementary strategy when more is known. Widely disseminating a vaccine candidate without efficacy data will not serve the public health nor achieve the goal of identifying safe and effective SARS Co-V-2 vaccines.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.