Days after privately held Bharat Biotech got a green signal for human studies for its vaccine candidate, the Drug Controller General of India (DGCI) has given similar approval to Zydus for its potential COVID-19 vaccine.
Zydus, a part of the Cadila Healthcare group, today said that its indigenously developed COVID-19 vaccine candidate – ZyCoV-D – has received permission from Indian authorities to conduct human trials after successfully completing pre-clinical phase.
“Zydus has already manufactured clinical good manufacturing practice (GMP) batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1,000 subjects,” the company said.
Zydus has developed ZyCoV-D at the company’s Vaccine Technology Centre in Ahmedabad. It has now received permission from the Drug Controller General of India (DGCI) – Central Drugs Standard Control Organisation (CDSCO) to initiate phase I/II human clinical trials in India, Cadila Healthcare said in a regulatory filing.
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According to Cadila Healthcare, 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 neutralization assay indicating the protective potential of the vaccine candidate, it said.
The company further said 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.
Zydus said, with its ZyCoV-D, it has successfully established the DNA vaccine platform in India using non-replicating and a non-integrating plasmid carrying the gene of interest making it very safe. The company claimed that the vaccine candidate has no vector response and with the absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements.