Zydus Cadila COVID-19 vaccine gets DCGI nod for human clinical trials
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.;
Ahmedabad: Drug firm Zydus announced that it's plasmid DNA vaccine candidate for COVID-19 (ZyCoV-D) developed indigenously at its Vaccine Technology Centre in Ahmedabad, India has successfully completed the preclinical phase and has now received permission from the Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I/II 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 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.
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