Sharma Alok, Ahmed Suhail, Kaur Jasleen, Chawla Rakesh, Rejeeth Chandrababu
Department of Pharmacognosy, ISF College of Pharmacy, Moga, Punjab 142001 India.
Department of Pharmacology and Toxicology, NIPER-Kolkata-700054, Kolkata, India.
Virusdisease. 2021 Jun;32(2):198-210. doi: 10.1007/s13337-021-00684-5. Epub 2021 May 5.
COVID-19 outburst initiated from the city of Wuhan in China in December 2019 and has been declared as a public health emergency of international concern. This pandemic portrays a spectrum of clinical complications, primarily affecting the respiratory system reported to be caused by a pathogen SARS-CoV-2 belonging to the family of beta coronavirus. Currently, the main objective of the government authorities of all affected countries and research organizations is to find a potential solution in the form of a pharmacological intervention or a vaccination to eradicate the disease and to have a long-term solution to deal with the pandemic. A multitude of anti-viral regimens is proposed based on the repurposing of currently available drugs for other issues or the compassionate use of drugs to immediately control and optimize the healthcare facilities. Meanwhile, a number of agencies are proposing new drug candidates to recreate the possibility of treating the disease. Similarly, a lot of research work is going on worldwide for the development of vaccination. Currently, a good number of candidates has finally reached the borders of Clinical Trials and are expected to be launched as soon as possible. However, the regulatory framework and authorization of these candidates is the most significant aspect of the whole scenario, which needs a specific set of time for validation purposes. The present work is widely focused on the general aspects of COVID-19 and the regulatory landscape for the emergency authorization of repurposed drug candidates, compassionate use of drugs, investigational entities, and vaccine development worldwide.
The online version contains supplementary material available at 10.1007/s13337-021-00684-5.
2019年12月，新冠疫情在中国武汉市爆发，并已被宣布为国际关注的突发公共卫生事件。这场大流行呈现出一系列临床并发症，主要影响呼吸系统，据报道是由一种属于β冠状病毒科的病原体严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起的。目前，所有受影响国家的政府当局和研究组织的主要目标是以药物干预或疫苗接种的形式找到一种潜在解决方案，以根除该疾病并找到应对大流行的长期办法。基于将现有药物用于其他问题的重新利用或药物的同情使用，提出了多种抗病毒方案，以立即控制和优化医疗设施。与此同时，一些机构正在提出新的候选药物，以重现治疗该疾病的可能性。同样，全球正在进行大量关于疫苗开发的研究工作。目前，相当数量的候选疫苗最终已进入临床试验阶段，并有望尽快推出。然而，这些候选疫苗的监管框架和授权是整个情况中最重要的方面，这需要特定的时间进行验证。本研究广泛关注新冠疫情的一般情况以及全球范围内重新利用的候选药物的紧急授权、药物的同情使用、研究实体和疫苗开发的监管情况。
在线版本包含可在10.1007/s13337-021-00684-5获取的补充材料。
