Zydus Cadila seeks nod for phase three clinical trials of Covid vaccine

The vaccine was found to be safe and well tolerated in tests on more than a thousand healthy adult volunteers in phase 1 and 2 trials

Zydus Cadila on Thursday submitted data from phase one and two clinical trials for its coronavirus vaccine ZyCov-D and sought approval for the next phase of tests.

The vaccine was found to be safe and well tolerated in tests on more than a thousand healthy adult volunteers, said the company, adding phase three clinical trial in around 30,000 volunteers upon receiving necessary approvals.

The multi-centre and randomized trials were reviewed by an independent Data Safety Monitoring Board (DSMB). Reports have been submitted to Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome.

Zydus Group chairperson Pankaj Patel said that company is optimistic of the phase III clinical trial outcomes as well. "We would be able to start production of the novel vaccine on its successful completion," he said.

The DNA platform used in ZyCoV-D improves the vaccine’s stability, lowering cold chain requirements and making it usable in remotest regions of the country. Administered through the intradermal route, it also allows for the ease of administration. 

Further, the platform also provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1). The platform can be used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection.

The plasmid DNA when introduced into the host cells would be translated into the viral protein and will elicit a strong immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in protection from disease as well as viral clearance. National Biopharma Mission, BIRAC, Department of Biotechnology, ICMR and NIV Pune have also supported the development of ZyCoV-D, the company acknowledged.