COVID-19 Vaccine Development and Introduction - A Review of Regulatory Process

  • Varun Singh B.Pharm, MBA (Healthcare Management), Public Health Expert. Former Consultant (Urban Health and RCH Division), Ministry of Health and Family Welfare (Government of India), New Delhi.
Keywords: COVID-19, SARS-CoV-2, New Vaccine Introduction, Emergency Use Authorization (EUA), Compassionate Use, Clinical Trials

Abstract

COVID-19 is the infectious disease caused by a novel strain of coronavirus (SARS-CoV-2) reported first in Wuhan, China, in December 2019. Coronaviruses are a family of viruses that causes illnesses like a common cold, MERS (Middle East Respiratory Syndrome), SARS (Severe Acute Respiratory Syndrome), etc. After the US and Brazil, India has reached the third rank in the world in terms of the high number of COVID-19 cases. To protect humans from the disease, a race has begun among vaccine developers around the world and hundreds of COVID-19 vaccine candidates are at various phases of the clinical trial. Many of us may not be aware about technical terms like clinical trial, compassionate use, emergency use etc., as well as various regulatory process involved. Therefore, the article is an attempt to chalk-out various concepts that are presently resonating with respect to COVID-19 vaccine development and introduction with few global examples. The article also aims to depicts the procedures for new vaccine approval & introduction process in India.

How to cite this article:
Singh S. COVID-19 Vaccine Development and Introduction - A Review of Regulatory Process. Epidem Int 2020; 5(3): 19-27.

DOI: https://doi.org/10.24321/2455.7048.202023

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Published
2020-09-30