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International Journal of Drug Development and Research

  • ISSN: 0975-9344
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Abstract

Biopharmaceutical Innovations and a race for Human Vaccines

Saumya Singh*

Biotechnology is the technological application of biological organisms, systems, and processes to develop, make, or modify products for specific uses such as pharmaceuticals, crops, and livestock. Traditional methods are the employment of artificial selection and hybridization, but modern usage also includes genetic engineering as well as cell and tissue culture technologies. In this research, we review some biotechnologies applied for the development and production of vaccines especially in respect of coronavirus. The immune response generated and efficacy rate achieved by these vaccine jabs of eminent biotechnology company is critically analysed. In light of the WHO specified vaccine approaches, viral vector vaccines and mRNA technology have received first time such wide approval in clinical trials and marketability. The regulatory mechanism globally and domestically has different implications to it. The biotechnology law being governed by the Drugs and Cosmetics Act 1940 and Rules 1945 in respect of new drug which also includes a new vaccine employing mRNA technology is observed together with the Clinical Trial Rules. Where on one hand without FDA approvals, WHO Emergency Listing has given place to vaccines like Pfizer, Jansen and Moderna; on the other hand, CDSCO and Clinical Trial Rules have given green signals to Covaxin and Covishield fast tracking the process to bring impactful vaccine in dire need. The world has received vaccines on a time-limited basis and based on a risk-versusbenefit evaluation defying the traditional time lagging process. The vaccination drive has become the flagship achievement of modern biotechnology which is immunizing billions of populations till the time we achieve the herd immunity and slow down the spread to zero.

Published Date: 2021-10-18; Received Date: 2021-08-09