BHARAT BIOTECH COVID VACCINE GETS NOD FOR HUMAN TRIALS
Bharat Biotech’s Covid vaccine candidate Covaxin is set to undergo human clinical trials in July. It was developed at the firm’s Genome Valley plant in Hyderabad, in collaboration with the Indian Council of Medical Research (ICMR).
On Monday, the Hyderabad-based firm said the Drug Controller General of India gave the green light for phase-1 and phase-2 human clinical trials of the indigenously developed drug, following submission of results generated from pre- clinical (animal) studies. These were meant to demonstrate safety and immune response.
The SARS- COV-2 strain was isolated at National Institute of Virology (Pune), an institute under the ICMR, and transferred to Bharat Biotech. Bharat Biotech has a biosafety level-3 plant in Hyderabad. These type of plants are appropriate for work involving microbes, which could cause serious and potentially lethal diseases, through the inhalation route.
Krishna Ella, chairman and managing director of Bharat Biotech, said: “We are proud to announce Covaxin, India’s first indigenous vaccine for Covid-19. The collaboration with ICMR and NIV was instrumental. The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”
Bharat Biotech had manufactured the H1N1 vaccine during the swine flu outbreak. The company has more than 140 global patents and a portfolio of over 16 vaccines.
Ahmedabad-based Cadila Healthcare was the first among Indian players to announce a vaccine candidate — it had also started pre - clinical studies. Pune-based Serum Institute and Delhibased Panacea Biotec, too, are leading candidates from India to develop a Covid-19 vaccine.