ReviewThe Lancet. Infectious diseases2021
Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities.
Review in The Lancet. Infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of COVID-19 vaccines.The Cochrane database of systematic reviews · 2022Pooled it
- Operational strategies among infectious disease clinical trial sites during pandemics: a scoping review.Trials · 2026Article
- A scoping review of ethics review processes during public health emergencies in Africa.BMC medical ethics · 2024Article
- The ethics of clinical research in the era of COVID-19.Frontiers in public health · 2024Review
- Neutralization against Omicron sublineages (BA.2/BA.5/BQ.1.1/XBB/XBB.1.5) in bivalent BNT162b2-vaccinated HCWs with or without risk factors, or following BT infection with Omicron.Scientific reports · 2023Article
- Article
- A comprehensive insight on the challenges for COVID-19 vaccine: A lesson learnt from other viral vaccines.Heliyon · 2023Review
- Ethical considerations of the vaccine development process and vaccination: a scoping review.BMC health services research · 2023Article
- Narrative review on century of respiratory pandemics from Spanish flu to COVID-19 and impact of nanotechnology on COVID-19 diagnosis and immune system boosting.Virology journal · 2022Review
- Neutralization activity of sera/IgG preparations from fully BNT162b2 vaccinated individuals against SARS-CoV-2 Alpha, Beta, Gamma, Delta, and Kappa variants.Scientific reports · 2022Article
- Real World Estimate of Vaccination Protection in Individuals Hospitalized for COVID-19.Vaccines · 2022Article
- Placebo control group in COVID-19 vaccine trials: context and timing matters.European journal of clinical pharmacology · 2022Review
- Restrictions on the use of placebo in new COVID-19 vaccine trials.European journal of clinical pharmacology · 2022Article
- A novel G-quadruplex aptamer-based spike trimeric antigen test for the detection of SARS-CoV-2.Molecular therapy. Nucleic acids · 2021Article
- Correlates of neutralizing/SARS-CoV-2-S1-binding antibody response with adverse effects and immune kinetics in BNT162b2-vaccinated individuals.Scientific reports · 2021Article
- Unveiling Associations of COVID-19 Vaccine Acceptance, Hesitancy, and Resistance: A Cross-Sectional Community-Based Adult Survey.International journal of environmental research and public health · 2021Article
- Current COVID-19 vaccine trials in high-income countries: are placebo-controlled trials ethical?Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2021Article
- New-onset and relapsing glomerular diseases related to COVID-19 vaccination.Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2021Article
- Are We Paving the Way to Dig Out of the "Pandemic Hole"? A Narrative Review on SARS-CoV-2 Vaccination: From Animal Models to Human Immunization.Medical sciences (Basel, Switzerland) · 2021Review
- Correlates of Neutralizing/SARS-CoV-2-S1-binding Antibody Response with Adverse Effects and Immune Kinetics in BNT162b2-Vaccinated Individuals.medRxiv : the preprint server for health sciences · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Large-scale deployment of COVID-19 vaccines will seriously affect the ongoing phases 2 and 3 randomised placebo-controlled trials assessing SARS-CoV-2 vaccine candidates. The effect will be particularly acute in high-income countries where the entire adult or older population could be vaccinated by late 2021. Regrettably, only a small proportion of the population in many low-income and middle-income countries will have access to available vaccines. Sponsors of COVID-19 vaccine candidates currently in phase 2 or initiating phase 3 trials in 2021 should consider continuing the research in countries with limited affordability and availability of COVID-19 vaccines. Several ethical principles must be implemented to ensure the equitable, non-exploitative, and respectful conduct of trials in resource-poor settings. Once sufficient knowledge on the immunogenicity response to COVID-19 vaccines is acquired, non-inferiority immunogenicity trials-comparing the immune response of a vaccine candidate to that of an authorised vaccine-would probably be the most common trial design. Until then, placebo-controlled, double-blind, crossover trials will continue to play a role in the development of new vaccine candidates. WHO or the Council for International Organizations of Medical Sciences should define an ethical framework for the requirements and benefits for trial participants and host communities in resource-poor settings that should require commitment from all vaccine candidate sponsors from high-income countries.
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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.