Accelerated Vaccine Trials during the COVID-19 Pandemic: A Methodological Review
DOI:
https://doi.org/10.32628/IJSRST25123117Keywords:
Vaccine Trial, Clinical Trial Methodology, Adaptive Trial, Covid-19Abstract
The COVID-19 pandemic catalyzed a paradigm shift in vaccine development, prompting the adoption of innovative clinical trial methodologies to accelerate timelines without compromising scientific integrity. This review critically examines the methodological adaptations employed during the development of COVID-19 vaccines, including overlapping and adaptive trial designs, the use of platform trials, regulatory flexibilities such as Emergency Use Authorizations, and the integration of decentralized and digitally enabled trial models. Ethical considerations, recruitment strategies, and challenges related to equity and public trust are also explored. While these innovations improved efficiency, they also highlighted the need for sustained attention to equity, transparency, and long-term safety monitoring in future vaccine research.
Downloads
References
Krammer, F. COVID-19 vaccines in development. Nature 586, 516–527 (2020). https://doi.org/10.1038/s41586-020-2798-3
Voysey, M., Clemens, S. A. C., Madhi, S. A., et al. (2021). Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against COVID-19. The Lancet, Volume 397, Issue 10269, 99 – 111.
Study Details | COVID-19 Vaccine (ChAdOx1 nCoV-19) Trial in South African Adults With and Without HIV-infection | ClinicalTrials.gov
Leila Janani, Rachel Phillips, Ellie Van Vogt, Xinxue Liu, Claire Waddington, Suzie Cro, Past, present, and future of Phase 3 vaccine trial design: rethinking statistics for the 21st century, Clinical and Experimental Immunology, Volume 219, Issue 1, 2025, uxae104, https://doi.org/10.1093/cei/uxae104
Operation Warp Speed: Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges | U.S. GAO
LaVange L, Adam SJ, Currier JS, Higgs ES, Reineck LA, Hughes EA, Read SW; ACTIV Therapeutics-Clinical Working Group. Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): Designing Master Protocols for Evaluation of Candidate COVID-19 Therapeutics. Ann Intern Med. 2021 Sep;174(9):1293-1300. doi: 10.7326/M21-1269. Epub 2021 Jun 29. PMID: 34181444; PMCID: PMC8244665.
Emergency Use Authorization for Vaccines Explained | FDA
Pfizer-BioNTech COVID-19 Vaccine EUA Letter of Authorization reissued 05-10-2021
Sharma O, Sultan AA, Ding H and Triggle CR (2020) A Review of the Progress and Challenges of Developing a Vaccine for COVID-19. Front. Immunol. 11:585354. doi: 10.3389/fimmu.2020.585354
Franco P, Jain R, Rosenkrands-Lange E, Hey C, Koban MU. Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries. Ther Innov Regul Sci. 2023 May;57(3):484-514. doi: 10.1007/s43441-022-00480-3. Epub 2022 Dec 3. PMID: 36463352; PMCID: PMC9734413.
Duroseau B, Kipshidze N, Limaye RJ. The impact of delayed access to COVID-19 vaccines in low- and lower-middle-income countries. Front Public Health. 2023 Jan 12;10:1087138. doi: 10.3389/fpubh.2022.1087138. PMID: 36711400; PMCID: PMC9878283.
Stern AD, Trusheim M. Transformation of the Clinical Trial Enterprise: Lessons Learned from the COVID-19 Pandemic: Final Report [Internet]. Washington (DC): Office of the Assistant Secretary for Planning and Evaluation (ASPE); 2024 Feb 9. 4, Decentralized clinical trials and digital health technologies. Available from: https://www.ncbi.nlm.nih.gov/books/NBK609002/#
Aiyegbusi, O.L., Cruz Rivera, S., Kamudoni, P. et al. Recommendations to promote equity, diversity and inclusion in decentralized clinical trials. Nat Med 30, 3075–3084 (2024). https://doi.org/10.1038/s41591-024-03323-w
Seema K. Shah et al. ,Ethics of controlled human infection to address COVID-19.Science368,832-834(2020).DOI:10.1126/science.abc1076
Dal-Ré R. Placebo control group in COVID-19 vaccine trials: context and timing matters. Eur J Clin Pharmacol. 2022 Mar;78(3):523-526. doi: 10.1007/s00228-021-03259-x. Epub 2021 Nov 27. PMID: 34837495; PMCID: PMC8626740.
Khine H, Mathson A, Moshele PR, Thyagarajan B, Karger AB, Thomas SN. Targeted electronic health record-based recruitment strategy to enhance COVID-19 vaccine response clinical research study enrollment. Contemp Clin Trials Commun. 2023 Dec 20;37:101250. doi: 10.1016/j.conctc.2023.101250. PMID: 38312474; PMCID: PMC10837691.
Hill J, Montross D, Ivarsson M. Diversity and inclusion in clinical trials: Evolution throughout the development of an mRNA COVID-19 vaccine. Front Public Health. 2023 Apr 26;11:1113003. doi: 10.3389/fpubh.2023.1113003. PMID: 37181705; PMCID: PMC10169614.
COVID-19 Vaccine Equity for Racial and Ethnic Minority Groups | CDC Archive
Brown P, Waite F, Larkin M, Lambe S, McShane H, Pollard AJ, Freeman D. "It seems impossible that it's been made so quickly": a qualitative investigation of concerns about the speed of COVID-19 vaccine development and how these may be overcome. Hum Vaccin Immunother. 2022 Dec 31;18(1):2004808. doi: 10.1080/21645515.2021.2004808. Epub 2022 Feb 16. PMID: 35172678; PMCID: PMC8928812.
Tafere C, Demsie DG, Tefera BB, et al. Vaccine skepticism and vaccine development stages; inoculation from “cowpox” lesion to the current mRNA vaccine of COVID-19: review. Therapeutic Advances in Vaccines and Immunotherapy. 2024;12. doi:10.1177/25151355241288135
Bolsen T, Palm R. Politicization and COVID-19 vaccine resistance in the U.S. Prog Mol Biol Transl Sci. 2022;188(1):81-100. doi: 10.1016/bs.pmbts.2021.10.002. Epub 2021 Nov 10. PMID: 35168748; PMCID: PMC8577882.
Downloads
Published
Issue
Section
License
Copyright (c) 2025 International Journal of Scientific Research in Science and Technology
This work is licensed under a Creative Commons Attribution 4.0 International License.
