Zydus Cadila gets DCGI nod for potential COVID-19 vaccine trials on humans
Zydus, a part of the Cadila Healthcare group, on Friday said its indigenously developed COVID-19 vaccine candidate — ZyCoV-D — has successfully completed pre-clinical phase, and has received permission from Indian authorities to conduct human trials.
"Zydus has already manufactured clinical good manufacturing practise (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," the company said.
ZyCoV-D, developed at the company's Vaccine Technology Centre in Ahmedabad, has now received permission from the Drug Controller General of India (DCGI) - Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I/II human clinical trials in India, Cadila Healthcare said in a regulatory filing.
In animal studies, the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs, and rabbits. The antibodies produced by the vaccine were able to completely neutralise the wild type virus in virus neutralisation assay, indicating the protective potential of the vaccine candidate, it said.
It further said no safety concerns were observed for the vaccine candidate in repeat-dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well-tolerated, and immunogenic.
Zydus said, with its ZyCoV-D, it has successfully established the DNA vaccine platform in India, using a non-replicating and non-integrating plasmid carrying the gene of interest making it very safe.
The company claimed that the vaccine candidate has no vector response, and with the absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal bio-safety requirements.
It is also known to show much-improved vaccine stability and lower cold chain requirements, making it easy for transportation to remotest parts of the country, it said.
"Furthermore, the platform can be rapidly used to modify the vaccine in couple of weeks in case the virus mutates, to ensure that the vaccine still elicits protection," it added.
The company now intends to rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.