India's first COVID vaccine Covaxin gets DCGI nod for human trials; maker issues statement

In a significant development and towards a breakthrough of a potential vaccine for COVID-19, Drug Controller General of India (DGCI) has given a green signal for conducting the human trials of India's first COVID-19 vaccine 'Covaxin'. The development comes after the Union Health Ministry gave a nod for clinical human trials of the potential vaccine after successfully testing it on animals.

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Covaxin has been approved for Phase I & II Human Clinical Trials which will begin from July. The vaccine is being developed by Bharat Biotech in Hyderabad in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

Announcing the milestone, Dr Krishna Ella, chairman and managing director of Bharat Biotech, said, “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. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”

Suchitra Ella, joint managing director of 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.”

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Race to COVID-19 vaccine

There are several international pharmaceutical manufacturers in the race across the world to develop COVID-19 vaccine. Pharma major AstraZeneca in collaboration with Oxford University's Jenner Institute and the Oxford Vaccine Group has ramped up its capacity to produce a vaccine for COVID-19 on a wide scale. 

The British drugmaker was already in human trials phase of the vaccine developed by the University of Oxford, with a phase I trial in Britain due to end soon and a phase III trial already begun,  CEO of AstraZeneca, Pascal Soriot had told broadcaster Bel RTL.

China too is said to have developed a vaccine in association with the help of Chinese vaccine company CanSino Biologics, which shows promising results in early clinical trials.