Healthcare major Zydus Cadila said on Friday its plasmid DNA vaccine candidate for COVID-19 (ZyCoV-D) developed indigenously at its vaccine technology centre here has successfully completed the pre-clinical phase.
The company has received permission from the Drug Controller General of India -- the Central Drugs Standard Control Organisation (CDSCO) -- to initiate phase one and two human clinical trials in India.
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.
No safety concerns were observed for the vaccine candidate in repeat-dose toxicology studies by both intramuscular and intradermal routes of administration, said Zydus. In rabbits, up to three times the intended human dose was found to be safe, well-tolerated and immunogenic.
Zydus has already manufactured clinical GMP batches of the vaccine candidate and plans to initiate theclinical trials in July across multiple sites in India in over 1,000 subjects. With ZyCoV-D, the company has successfully established the DNA vaccine platform in the country using non-replicating and a non-integrating plasmid carrying the gene of interest making it very safe.
Further, no vector response and with the absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1). The platform is also known to show much-improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest regions of the country.
Furthermore, 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. "The company intends to now rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand," it said in a statement.
Zydus was the first company in India to develop and indigenously manufacture the vaccine to combat swine flu during the pandemic in 2010.