The Pune-based Serum Institute of India and Hyderabad-based pharmaceutical company Bharat Biotech have already approached the Controller General of Medicines of India (DCGI) to request an emergency use authorization for their potential vaccines. Covid-19. A committee of experts from the Central Medicines Standards Control Organization (CDSCO) has sought additional data on the safety and efficacy of Serum and Bharat Biotech after deliberating on their applications. The Indian arm of the US pharmaceutical giant Pfizer has also applied for emergency use approval.
At its press conference this week, the Union’s health ministry had indicated that the three candidates can obtain an advance license after reviewing data from ongoing trials.
Giving a bird’s-eye view of the Indian landscape of Covid-19 vaccines, Union Health Secretary Rajesh Bhushan had mentioned that eight vaccines are in different stages of development in India.
One is Covishield, which is being manufactured by the Serum Institute of India in collaboration with AstraZeneca. Phase two and three clinical trials of this vaccine are underway and the company has applied for an emergency use authorization.
Another is Covaxin, which is being indigenously developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) and is currently in phase three of clinical trials. It has also requested the authorization of emergency use from DCGI.
The third is ZyCOV-D, which is being developed by Cadila Healthcare Ltd in Ahmedabad in collaboration with the Central Government Department of Biotechnology and is in phase two of the trials.
The fourth candidate vaccine is Sputnik V, which is being manufactured by Dr. Reddy’s Lab, Hyderabad, in collaboration with the Gamaleya National Center of Russia and in accordance with their mutual agreement. The phase two trial in India has ended and phase three will begin next week.
The fifth is NVX-CoV2373, which is being developed by the Serum Institute of India in collaboration with Novavax and its phase three clinical trial is under consideration with the drug regulator.
The sixth candidate vaccine is a recombinant protein antigen-based vaccine, which will be manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA. Its preclinical studies in animals have been completed and phase human clinical trials have begun. one and two. Another is HGCO 19 manufactured by Genova in Pune in collaboration with HDT, USA Its preclinical studies in animals have been completed and phases one and two clinical trials are scheduled to begin.
The eighth vaccine is being developed by Bharat Biotech International Ltd in collaboration with Thomas Jefferson University, USA and is in the preclinical stages.
“Another vaccine, which is in the early stages, is the one being developed by Aurbindo Pharma. So there are a total of nine vaccines of which six are in clinical trials and three are in the preclinical stage,” Bhushan said.
India makes more than 60% of all vaccines sold worldwide, and while its $ 40 billion pharmaceutical sector is not yet involved in the production of Pfizer Inc and Moderna’s expensive injections, the nation will play a pivotal role in immunization of much of the world. .
(With inputs from agencies)
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