Sagili Anthony Deva Priya, Sivakumar Kavitha, Venugopal Priyanka, Sriram Damal Kandadai, George Melvin
Department of Clinical Research, Hindu Mission Hospital, Tambaram, Chennai, 600 045, India.
Diabetology and Endocrinology, Hindu Mission Hospital, Tambaram, Chennai, 600 045, India.
Clin Drug Investig. 2021 Jun;41(6):499-509. doi: 10.1007/s40261-021-01022-9. Epub 2021 Mar 23.
The COVID-19 pandemic continues to affect millions of people across the world. The current global statistics for the disease are 111 million cases and 2.45 million deaths, with new cases emerging each day. Although several drugs including remdesivir have been approved for emergency use, they remain ineffective in bringing the infection under control. Therefore, there is a need for highly effective and safe vaccines against COVID-19. The recent advancements in mRNA vaccines have catapulted them to be forefront in the race to develop vaccines for COVID-19. Two mRNA vaccines, BNT162b2 and mRNA-1273, developed by Pfizer-BioNTech and Moderna Therapeutics, respectively, have been granted authorization for emergency use by the US Food and Drug Administration. Interim analysis of the clinical trials for BNT162b2 and mRNA-1273 vaccines reported an efficacy of 95% and 94.1%, respectively, after the second dose. The adverse events for both the vaccines have been found to be mild to moderate, with mostly injection-site reactions and fatigue. No serious adverse events have been reported. Moreover, Pfizer-BioNTech and Moderna Therapeutics have announced that their vaccines are effective even against the new strains (B.1.17 and B.1.351) of the virus. Both companies are now scaling up the production of the vaccines to meet the global demand. Although the long-term efficacy, safety, and immunogenicity of these vaccines is uncertain, there is hope that they can turn the tables against COVID-19 in this current pandemic situation.
新冠疫情持续影响着全球数百万人。该疾病目前的全球统计数据为1.11亿例病例和245万例死亡,且每天都有新病例出现。尽管包括瑞德西韦在内的几种药物已被批准用于紧急使用,但它们在控制感染方面仍然无效。因此,需要研发高效且安全的新冠疫苗。信使核糖核酸(mRNA)疫苗的最新进展使其在新冠疫苗研发竞赛中处于领先地位。辉瑞-生物科技公司研发的BNT162b2和莫德纳疗法公司研发的mRNA-1273这两种mRNA疫苗已获得美国食品药品监督管理局的紧急使用授权。对BNT162b2和mRNA-1273疫苗临床试验的中期分析报告称,第二剂接种后,二者的有效率分别为95%和94.1%。已发现这两种疫苗的不良事件均为轻度至中度,主要是注射部位反应和疲劳。未报告严重不良事件。此外,辉瑞-生物科技公司和莫德纳疗法公司均宣布,其疫苗对该病毒的新毒株(B.1.17和B.1.351)也有效。两家公司目前都在扩大疫苗生产以满足全球需求。尽管这些疫苗的长期有效性、安全性和免疫原性尚不确定,但人们希望在当前的疫情形势下,它们能够扭转局势战胜新冠病毒。