Ahmedabad-based Zydus on Friday (3 July) announced that that it’s plasmid DNA vaccine candidate for COVID-19 has been approved by the Drug Controller General of India (DCGI) for phase 1 and 2 human clinical trials.
Named ZyCoV-D, the Zydus vaccine candidate has been indigenously developed by the company at its Vaccine Technology Centre in Ahmedabad.
"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 neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate," Zydus said in a statement.
No safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration, the company said.
The company further added that 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 the clinical trials in July 2020 across multiple sites in India in over 1000 subjects," it said.
"With ZyCoV-D, the Company has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe. Further, no vector response and with absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1)," Zydus said.
With much improved vaccine stability and lower cold chain requirements, the platform alos makes it easy for transportation to remotest regions of the country, it added.
The DNA platform 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.
Zydus further said that it now intends to rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.
The DCGI nod to Zydus for human trials of the vaccine candidate comes days after the drug regulator had approved the phase 1 and 2 clinical trials of the Hyderabad-based Bharat Biotech's potential Covid-19 vaccine called COVAXIN.
Bharat Biotech is also starting the human trials of its potential covid-19 vaccine candidate from July.
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