International Journal of Clinical Case Reports 2024, Vol.14, No.3, 117-131 http://medscipublisher.com/index.php/ijccr 117 Review Article Open Access Safety and Efficacy of mRNA Vaccines: Insights from Clinical Trials Lihui Xu, Tingting Feng, Keyan Fang Traditional Chinese Medicine Research Center, Cuixi Academy of Biotechnology, Zhuji, 311800, Zhejiang, China Corresponding author: keyan.fang@cuixi.org International Journal of Clinical Case Reports 2024, Vol.14, No.3 doi: 10.5376/ijccr.2024.14.0014 Received: 16 Apr., 2024 Accepted: 20 May, 2024 Published: 01 Jun., 2024 Copyright © 2024 Xu et al., This is an open access article published under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Preferred citation for this article: Xu L.H., Feng T.T., and Fang K.Y., 2024, Safety and efficacy of mRNA vaccines: insights from clinical trials, International Journal of Clinical Case Reports, 14(3): 117-131 (doi: 10.5376/ijccr.2024.14.0014) Abstract The rapid rise of mRNA vaccines during the COVID-19 pandemic has demonstrated exceptional efficacy and safety. However, comprehensive studies on their long-term safety and efficacy across different populations are still ongoing. This study evaluates the safety and efficacy of mRNA vaccines in disease prevention based on clinical trial data, providing a basis for public health policy-making, vaccine promotion, and future vaccine development. By comparing the performance of mRNA vaccines with traditional vaccines, the study reveals their characteristics in terms of protective efficacy, adverse reactions, and applicability to special populations, offering references for optimizing vaccine selection and vaccination strategies. Additionally, the study addresses the challenges mRNA vaccines face in development, production, distribution, and public acceptance, exploring their future development directions. This provides scientific evidence for future vaccine development and public health decision-making. Keywords mRNA vaccines; Safety; Efficacy; Clinical trials; Vaccine development 1 Introduction Messenger RNA (mRNA) vaccines represent a groundbreaking advancement in the field of vaccinology, offering a promising alternative to traditional vaccine approaches. Unlike conventional vaccines, which often rely on inactivated pathogens or protein subunits, mRNA vaccines utilize synthetic mRNA to instruct cells to produce specific proteins that trigger an immune response. This innovative approach has several advantages, including high potency, rapid development, and the potential for low-cost manufacturing and safe administration (Pardi et al., 2018; Maruggi et al., 2019; Zhang et al., 2019). Recent technological advancements have significantly improved the stability and delivery efficiency of mRNA, making it a viable platform for both prophylactic and therapeutic vaccines (Pardi et al., 2018; Gote et al., 2023). The concept of mRNA-based vaccines has been explored for over two decades, but it was not until recent years that significant progress was made in overcoming the challenges associated with mRNA instability and inefficient in vivo delivery (Pardi et al., 2018; Maruggi et al., 2019; Yang et al., 2022). The COVID-19 pandemic accelerated the development and approval of mRNA vaccines, with the Pfizer-BioNTech and Moderna vaccines becoming the first mRNA vaccines to receive emergency use authorization from regulatory agencies worldwide (Korang et al., 2022; Gote et al., 2023; Zhang, 2023). These vaccines have demonstrated high efficacy in preventing COVID-19 and have set a precedent for the rapid development and deployment of mRNA vaccines against other infectious diseases (Kim et al., 2021; Korang et al., 2022). As mRNA vaccines continue to gain prominence, it is crucial to thoroughly evaluate their safety and effectiveness. Clinical trials and real-world data have shown that mRNA vaccines can induce potent and long-lasting immune responses with a favorable safety profile (Zhang et al., 2019; Jackson et al., 2020; Korang et al., 2022). However, ongoing monitoring and further research are necessary to fully understand the long-term safety and potential adverse effects of these vaccines (Korang et al., 2022). Evaluating the safety and efficacy of mRNA vaccines is essential to ensure public confidence and to guide future vaccine development efforts (Korang et al., 2022; Yang et al., 2022). This study provides a comprehensive analysis of the safety and efficacy of mRNA vaccines by synthesizing data from clinical trials and real-world studies. By aggregating data from multiple sources, this study aims to
RkJQdWJsaXNoZXIy MjQ4ODYzNQ==