VACCINES VERSUS COVID-19 VACCINES: MANEUVER TIMELINE OF DEVELOPMENT AND TRIAL DESIGNS
Development of vaccines and COVID-19 vaccines
Abstract
Recent pandemic of coronavirus disease 2019 (COVID-19) has made a serious threat to public health and became a global burden with millions of people at risk of death. At that time, there were no approved antiviral drugs and vaccines for COVID-19, but few drugs are repurposed with limited benefit. In less than a year, several COVID-19 vaccines have already been approved and hundreds of vaccines are undergoing clinical evaluation. This review focuses on need for vaccines, benefits of vaccination, the World Health Organization initiated new global strategy ‘the Immunization Agenda 2030’ (IA2030), stages and timeline of development, and clinical evaluation of traditional vaccines. We have summarized comparison of clinical evaluation between traditional vaccines and conventional drugs in the pre-pandemic era. The review briefly discusses the prioritized approaches, accelerated timeline of clinical evaluation, and seamless and immunobridging clinical trial designs of COVID-19 vaccines in the pandemic period. We have thoroughly searched recent literature and data on this topic and made a summary of current advances, regulatory amendments, and future perspectives of development and approval of vaccines.
Keywords:
COVID-19, Emergency use authorization, IA2030, Immunobridging, Seamless design, Vaccine for COVID-19
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References
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29. Pasupulati H, Avadhanula V, Mamilla A, Bamini M, Padi SSV. Antibiotic prescribing practices in primary care settings using 2019 WHO AWaRe framework. J Pharm Res Int. 2021;33(37A):58-66.
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31. Jordan VC. The 4Ps of Breast Cancer Chemoprevention: Putting proven principles into practice. Cancer Prev Res (Phila). 2017;10(4):219-222.
32. Egilman A, Wallach JD, Puthumana J, Zhang AD, Schwartz JL, Ross JS. Characteristics of preapproval and postapproval studies of vaccines granted accelerated approval by the US Food and Drug Administration. J Gen Intern Med. 2021;36(10):3281-3284.
33. D'Amico C, Fontana F, Cheng R, Santos HA. Development of vaccine formulations: past, present, and future. Drug Deliv Transl Res. 2021;11(2):353-372.
34. Han S. Clinical vaccine development. Clin Exp Vaccine Res. 2015 Jan;4(1):46-53.
35. Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. COVID-19 vaccines: rapid development, implications, challenges and future prospects. Hum Cell. 2021;34(3):711-733.
36. Kalinke U, Barouch DH, Rizzi R, Lagkadinou E, Türeci Ö, Pather S, Neels P. Clinical development and approval of COVID-19 vaccines. Expert Rev Vaccines. 2022;21(5):609-619.
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41. Li M, Wang H, Tian L, Pang Z, Yang Q, Huang T, et al. COVID-19 vaccine development: milestones, lessons and prospects. Signal Transduct Target Ther. 2022;7(1):146.
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50. Jiang Z, Wang X, Xia J. Considerations on the clinical development of COVID-19 vaccine from trial design perspectives. Hum Vaccin Immunother. 2021;17(3):656-660.
51. Su SC, Li X, Zhao Y, Chan IS. Population-enrichment adaptive design strategy for an event-driven vaccine efficacy trial. Stat. Biosci. 2018;10(2):357–370.
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09-06-2023
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Gaddam S, Pasupulati H, Padi S. VACCINES VERSUS COVID-19 VACCINES: MANEUVER TIMELINE OF DEVELOPMENT AND TRIAL DESIGNS: Development of vaccines and COVID-19 vaccines. World Journal of Current Med and Pharm Research [Internet]. 2023Jun.9 [cited 2025May18];5(3):51-. Available from: https://wjcmpr.com/index.php/journal/article/view/265
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