Zydus to begin human clinical trials for Covid vaccineJuly 03, 2020 10:59
As we wait for further news from the PM's visit to Leh, here's something to keep your spirits up.
Healthcare major Zydus Cadila said on Friday its plasmid DNA vaccine candidate for COVID-19 (ZyCoV-D) developed indigenously at its vaccine technology centre 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.