ReviewNPJ vaccines2020
Navigating facilitated regulatory pathways during a disease X pandemic.
Review in NPJ vaccines, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 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
21 citing papers in PubMed.
- Vaccinology in the twenty-first century revisited.NPJ vaccines · 2026Article
- Targeting the lethal weakness of SFTSV: Latest advances in antiviral strategies and immune prevention.iScience · 2026Review
- Confronting the known unknown: historical lessons and future strategies for Disease X.Frontiers in public health · 2026Review
- Approval delays in multi-country COVID-19 trials: the case of COPCOV and the risk of therapeutic inertia.Trials · 2025Article
- Policies to promote affordability and access across the life cycle of costly new drugs.BMJ (Clinical research ed.) · 2025Article
- Artificial intelligence for disease X: Progress and challenges.Journal of translational internal medicine · 2024Article
- Structure-Based In Silico Screening of Marine Phlorotannins for Potential Walrus Calicivirus Inhibitor.International journal of molecular sciences · 2023Article
- Strengthening clinical development activities and preparedness for vaccine manufacturers from emerging countries: Results of a survey.Vaccine: X · 2023Article
- Article
- Medicines Regulatory Science Expertise in Africa: Workforce Capacity Development and Harmonisation Activities Towards the Establishment of the African Medicines Agency.Pharmaceutical medicine · 2022Article
- Large-scale decontamination of disposable FFP2 and FFP3 respirators by hydrogen peroxide vapour, Finland, April to June 2020.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2022Article
- Reboot biomedical R&D in the global public interest.Nature · 2022Article
- COVID-19 vaccines-The way forward.Allergy · 2022Article
- Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America.Revista panamericana de salud publica = Pan American journal of public health · 2022Article
- Review
- Perspectives in the study of the political economy of COVID-19 vaccine regulation.Regulation & governance · 2021Article
- COVID-19 vaccine challenges: What have we learned so far and what remains to be done?Health policy (Amsterdam, Netherlands) · 2021Review
- Promoting versatile vaccine development for emerging pandemics.NPJ vaccines · 2021Review
- Article
- A review of 2020 through Nature's editorials.Nature · 2020Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In 2018, the Bill and Melinda Gates Foundation convened over thirty subject matter experts in clinical development, manufacturing, and regulatory assessment to determine how the development and approval of medical countermeasures could be accelerated in the event of Disease X. Disease X is the result of a presently unknown pathogen with epidemic or pandemic potential. A key opportunity to accelerate the scientific assessment and regulatory approval of medical countermeasures exists within efficient navigation of facilitated regulatory pathways. It was identified that not all stakeholders will be able to skillfully navigate the facilitated pathways offered by the various regulatory agencies during a public health emergency. To democratize this knowledge, we have written an overview of the facilitated approaches which have been developed and refined by Stringent Regulatory Authorities and the World Health Organization for the primary assessment of medical products. We discuss the conditions necessary for use of these approaches, scenarios in which certain pathways may be applicable, and the pros and cons of these approaches. We also address opportunities available to developers in, or developers who wish to access, low-income countries that may have nascent regulatory frameworks.
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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.