Hyderabad: A leading biotech company of Hyderabad, Bharat Biotech announced COVAXIN as India’s first approved COVID vaccine for phase I and II human clinical trials, on Monday (June 29).
COVAXIN, a drug manufactured by them, has been approved by the Drug Controller General of India (DCGI). The company has been working on the drug collaborating with the Indian Council of Medical Research (ICMR) and National Institute of Virology, Pune.
COVAXIN is an inactivated vaccine developed from the strains of SARS-COV-2 virus, which has shown effectiveness in preclinical studies. Chairman and Managing Direction of Bharat Biotech, Krishna Ella 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 the Central Drugs Standard Control Organisation (CDSCO) have enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.” “COVAXIN was evaluated in animals as per schedule Y guidelines of India and World Health Organisation. It was reported to be safe and immunogenic in all animals. We have now moved forward towards clinical development of this vaccine,” He was quoted as saying by The Times of India.
The DGCI, Central Drugs Standard Control Organisation (CDSCO) and Ministry of Health and Family Welfare granted permission to initiate Phase I and II human clinical trials which are scheduled in July across the country.
The virus has already claimed over five lakh lives worldwide, and 16,917 victims in India. Drug manufacturer around the world is racing to develop an efficient vaccine against the Coronavirus that has never been identified in the human body before. India, a leading manufacturer of drugs, is expected to have a key role in the race for making a vaccine.