India’s drug controller has given approval for human clinical trials of the country’s first coronavirus disease (Covid-19) vaccine candidate, which has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), the vaccine maker said on Monday.
The trials for the vaccine, named Covaxin, are likely to begin next month, the firm said. The strains of Sars-CoV-2 that causes Covid-19 was isolated by ICMR-NIV and transferred to Bharat Biotech in May. Scientists have managed to isolate and culture 11 strains that can be used to develop vaccines and aid research.
The indigenous and inactivated vaccine candidate was developed and manufactured at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.
“The Drug Controller General of India… granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020,” the company said.
Krishna Ella, chairman and managing director, Bharat Biotech, said: “We are proud to announce COVAXIN, India’s first indigenous vaccine against Covid-19.The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from Central Drugs Standard Control Organisation (CDSCO) has enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”
In the two phases, experts test if a vaccine is safe to be administered in humans and to establish trends of its efficacy.
There are 13 experimental vaccines in clinical trials and another 129 in the pre-clinical evaluation stage on June 22, according to World Health Organization’s draft landscape of Covid-19 vaccines on June 22.
The company completed comprehensive pre-clinical studies in two months after receiving regulatory approvals. Results from these studies have been promising and show extensive safety and effective immune responses, the company said.
“Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic. Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics,” said Suchitra Ella, joint managing director, Bharat Biotech.
ICMR-NIV managed to isolate the virus from swab samples in early February from initial Covid-19 patients in Kerala.
“It normally takes about two-three months for the vaccine candidate to be ready, and then different studies are undertaken to test the vaccine candidate. The next phase of trials will be equally crucial,” said an ICMR official, asking not to be named.
Source : Hindustan Times0