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India-based biotechnology company Bharat Biotech has secured regulatory approval from the Drug Controller General of India (DCGI) to advance its Covid-19 vaccine candidate, Covaxin, into human clinical trials.
This marks the first regulatory approval for India’s domestic vaccine to enter trials. DCGI’s approval will enable the company to conduct Phase I and II studies, which are set to begin next month.
Covaxin has been developed in partnership with the Indian Council of Medical Research’s National Institute of Virology. The inactivated vaccine was manufactured in Bharat Biotech’s facility at Genome Valley in Hyderabad, India.
Bharat Biotech chairman and managing director 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 CDSCO has enabled approvals to this project.”
In April this year, Bharat Biotech partnered with FluGen and University of Wisconsin–Madison (UWMadison) to develop and evaluate a Covid-19 vaccine candidate, CoroFlu.
CoroFlu will be administered intranasally with an aim to induce multiple immune responses.
Later in May, Bharat Biotech entered into an exclusive agreement to develop a Covid-19 vaccine candidate created at Thomas Jefferson University in Philadelphia, US.
Thomas Jefferson professor developed this vaccine candidate in January using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins.
Apart from Bharat Biotech, multiple companies in India are working to develop a Covid-19 vaccine, including Zydus Cadila, Serum Institute of India (SII) and Panacea Biotec. Currently, these candidates are in preclinical development stage.
In addition, SII entered a licensing agreement with AstraZeneca for one billion doses of a Covid-19 vaccine developed by the University of Oxford. AstraZeneca agreed to supply 400 million doses before the end of this year.