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ORIGINAL RESEARCH article
Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1482035
This article is part of the Research Topic Pandemic Preparedness in Vaccine Safety and Regulation View all 3 articles
Accelerated Therapeutic Development During COVID-19: Insights, Regulatory Strategies, and Recommendations for Future Pandemic Preparedness
Provisionally accepted- Tokyo University of Science, Tokyo, Japan
The clinical development of therapeutics for COVID-19 proceeded at an extraordinary pace. Given the lack of studies evaluating this experience systematically, we analyzed the clinical development methods for COVID-19 therapeutics to determine strategies for shortening the clinical development period in preparation for future pandemics. Methods: We confirmed the US-FDA review documents for fourteen products that underwent Emergency Use Authorization (EUA) in the US during the COVID-19 pandemic to examine the time required for clinical development and regulatory review and the submitted data for EUA. Results: Six of the fourteen products with clinical study data for other indications were evaluated in fewer studies than new molecular entities. The application data for each product included the stipulated content, and placebo-controlled comparative studies were included for all products. Clinical development measures were adopted, including adaptive protocol design, nonsequential phase development, and clinical dose adaptation based on non-clinical study results. Conclusions: Products with clinical study data for other indications are advantageous for early approval. However, early approval of new molecular entities is also important because they may not be sufficiently effective against new infectious diseases. It would be effective to approve a product promptly for a limited target population at first and then gradually expand it as data becomes more abundant. To prepare for future pandemics, we recommend establishing a framework for identifying candidates from existing products, managing and disseminating information in emergencies at various levels, and clarifying the conditions for applying regulatory flexibility to encourage pharmaceutical companies to make early decisions regarding clinical development.
Keywords: COVID-19, SARS-CoV-2, Emergency use authorization, pandemic, Clinical development, 100 Days Mission, streamlined development
Received: 17 Aug 2024; Accepted: 28 Mar 2025.
Copyright: © 2025 KATAYAMA and Shikano. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
MIYUKI KATAYAMA, Tokyo University of Science, Tokyo, Japan
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.