Regulatory approval pathway for COVID-19 vaccine in USA, Europe and India.

Abstract

The coronavirus disease-2019 (COVID-19) outbreak has confused everyone, including healthcare experts, physicians and frontline workers. Monoclonal antibodies, anticoagulants and immunomodulatory therapy were initially used to treat COVID-19. However, they can only inhibit the virus from replicating, which is not enough to provide a lasting cure. As each month passes, a growing number of companies are working on vaccinations that will aid in the development of resistance against the corona virus. As a result, all regulatory bodies have stated that if a vaccine has high efficacy and low risk of adverse events, it will be approved through an emergency use application. However, there is one major hindrance: After completing phase II clinical trials with an emergency use application, the product can be released to the market. However, the firm should conduct phase III and phase IV trials at the same time, with peer review occurring after each cycle of clinical trials and also market data to be presented simultaneously to track adverse events. In this article, the author has compared the standard approval process (i.e. Standard Biological License application) with the emergency use application to describe how the COVID-19 vaccine was approved by the different regulatory bodies.