Zydus Cadila seeks govt nod to start Phase-III clinical trials of COVID-19 vaccine

NEW DELHI: Drug firm Zydus Cadila on Thursday said its vaccine against COVID-19, 'ZyCoV-D', has been found to be safe and immunogenic in the Phase I/II clinical trials, and the company is seeking regulatory approval to commence Phase-III trials. The company's "plasmid DNA vaccine to prevent COVID-19, ZyCoV-D, was found to be safe, well tolerated and immunogenic in the Phase I/II clinical trials. The company is now planning to initiate Phase III clinical trials in around 30,000 volunteers upon receiving necessary approvals," Zydus Cadila said in a statement.

The Phase-II study of the vaccine, ZyCoV-D, had been conducted in over 1,000 healthy adult volunteers as part of the adaptive Phase-I and II dose escalation, multi-centric, randomised and double-blind placebo controlled study. The vaccine was found to be safe and immunogenic, he added.

The trial has been reviewed by an independent Data Safety Monitoring Board (DSMB) and reports have been submitted to the Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome, the statement said.


On the development, Zydus Group Chairman Pankaj R Patel said that after establishing safety in Phase-I clinical trial, ZyCoV-D has now completed Phase-II clinical trials and the vaccine has been found to be safe and immunogenic.

"We are optimistic of Phase-III clinical trial outcomes as well and that we would be able to start the production of the Novel Vaccine on its successful completion," he added.

With ZyCoV-D, the company has established the DNA vaccine platform in the country. The platform is also known to show much improved vaccine stability, thus requiring lower cold chain requirements. This makes the vaccine ideal for access in remotest regions of the country, Zydus Cadila said.

The platform can be rapidly used to modify the vaccine in a couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection, it added.

Shares of Cadila Healthcare, the listed entity of Zydus Group, on Thursday closed at Rs 489.65 per scrip on the BSE, up 3.14 per cent from its previous close.