Zydus’ vaccine gets DCGI nod for human trials

DNA PLATFORM

Zydus’ vaccine gets DCGI nod for human trials

Pharma Major To Ramp Up Production

TIMES NEWS NETWORK

Ahmedabad:  04.06.2020

Pharmaceuticals and healthcare major Zydus Cadila has received regulatory nod to start phase I and II human clinical trials in India of its vaccine candidate for Covid-19. Called ZyCoV-D, it is a plasmid DNA vaccine in trial stage. The approval has been issued by Drug Controller General of India (DCGI) - Central Drugs Standard Control Organisation (CDSCO.

Zydus Cadila has become the second company after Bharat Biotech to have received the approval to conduct human clinical trials for the potential Covid-19 vaccine.

“The company’s vaccine has successfully completed preclinical phase and has now received the permission to initiate phase I/II human clinical trials in India,” Zydus Cadila said in a statement on Friday.

The company’s vaccine candidate has been indigenously developed at its Vaccine Technology Centre in Ahmedabad.

Pankaj Patel-promoted Zydus Cadila has already manufactured clinical GMP batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1,000 subjects.

“In animal studies, the vaccine was found to elicit a strong immune response in species like mice, rats, guinea pigs and rabbits. No safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration,” added the company.

With ZyCoV-D, Zydus has successfully established the DNA vaccine platform, which can also be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection.