Biological E, the second biggest vaccine maker after Bharat Biotech from Hyderabad, has successfully completed the phase-2 and phase-3 clinical trials on its Corbevax Covid vaccine, which is being developed by the firm in collaboration with Baylor College of Medicine, Houston, Texas and Dynavax from California.

According to Mahima Datla, chairman and managing director of Biological E, the phase-2 and phase-3 clinical trials have already been successfully completed recently and the same will be submitted to the DCGI for getting emergency usage authorization (EUA).

“The Corbevax clinical trials which were conducted in 15 different hospitals in India have already been concluded, the final results of the clinical trial data will be submitted to the Drug Control General of India for getting emergency usage authorization. As we are expecting DCGI’s nod by end of November, we are preparing ground for the launch of the vaccine in India as soon as we get the permission from the Indian regulatory,” informed the CMD.

It is already known that Biological E is manufacturing Corbevax Covid vaccine in collaboration with US based Baylor College of medicine and Dynavax from Texas and California respectively.   

For conducting the second and third phase clinical trials for Corbevax, the Asian Institute of Gastroenterology (AIG) at Gatchibowli was chosen from Hyderabad. This apart the vaccine was tested in 14 more other centers across the country.

According to senior clinicians familiar with the clinical trials of the vaccine it is learnt that the vaccine comes in two doses was tested on as many as 1268 subjects in the age group from 18-80 years having moderate to high risk co-morbidities.

As the clinical trials have been completed successfully and soon after DCGI’s permission the Hyderabad based pharma giant has set a target of supplying 10 crore doses of Corbevax within days of its launch in India. Already the Indian government had invested 1,500 crore to buy Corbevax from Biological E. As part of this, the pharma company has already started manufacturing the vaccine in advance and stock pile the vaccine to be rolled out in one go as soon as it gets the DCGI nod.

The pharma giant earlier had also entered into a MoU with the US based International Development Finance Corporation for expanding its Shameerpet facility with an investment of $50 million in Hyderabad.