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Breaking: India's second COVID-19 vaccine approved for human trials; details inside

Saturday, July 4, 2020 • Tamil Comments

Days after India's first vaccine candidate against Covid-19, Hyderabad-based Bharat Biotech's Covaxin, received approval from the Drug Controller General of India (DCGI) to conduct Phase I and Phase II trials on human beings, another Covid-19 vaccine candidate developed by the pharmaceutical major Zydus Cadilla has received approval from the DGCI to conduct human trials.

The Ahmedabad based company, Zydus Cadilla, said that it received permission from the DCGI- Central Drugs Standard Control Organisation for phase I and II trials of the potential plasmid DNA vaccine after successfully completing the preclinical phase. "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. 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," the pharma company said. Adding that the clinical GMP batches of the vaccine candidate have already been prepared and the clinical trials will begin this month in over 1000 subjects, the company mentioned, "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."

"The platform is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to remote 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 further added.

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