India’s first Covid-19 vaccine, Covaxin by Bharat Biotech gets DCGI’s approval for human trials

Keeping in mind the present scenario, the unanimous need of the world is to come up with a vaccine for the novel coronavirus. In this respect, a new trial awaited vaccine has created new hopes for mankind. The first indigenous COVID-19 vaccine named COVAXIN, is developed by the city-based Bharat Biotech in collaboration with National Institute of Virology (NIV) and Indian Council of Medical Research (ICMR). The vaccine was approved by the Drug Controller General of India (DCGI) for the human clinical trial on Monday i.e., on 29th June 2020.

The vaccine for SARS-CoV-2 got the approval for its clinical trials viz. Phase I and Phase II right after its pre-clinical research has shown the safety and immune results. Both these phases trials are supposed to start in July 2020 all across India. Evidently, the successful collaboration with the NIV and ICMR proved to be helpful in the development of the vaccine, as what the company said in a release.

Bharat Biotechs BSL-3 (Bio-Safety Level 3), being a high containment facility established in the Genome Valley, was the location where this native and inactivated vaccine has been developed.

After Bharat Biotech offered the results generated from the pre-clinical research, which has shown the safety and immune response; the Indian drug authoritarian organization Drug Controller General of India CDSCO (The Central Drugs Standard Control Organization), Ministry of Health & Family Welfare gave their nod to start the clinical trials viz. Phase I & Phase II. These trials are organized to start across the nation in July 2020.

Dr. Krishna Ella, who is the Chairman and MD of the company gave his statement: We are proud to announce COVAXIN, Indias first indigenous vaccine against COVID-19. The collaboration between these organizations have proven to be influential for the sake of the development of this vaccine.

The company fast-tracked its objective to launch the vaccine, which speeded up through the national regulatory protocols. The response generated through these studies have been hopeful and have shown widespread safe as well as effective immune responses. It is worth mentioning that apart from the aforementioned Bharat Biotech, nearly five other companies of India are at work to bring the vaccine for the lethal COVID-19 pandemic while parallel endeavors are ongoing in various other nations as well.