Zydus Cadila has secured regulatory approval from the Drug Controller General of India (DCGI) to conduct Phase I/II human trials of its Covid-19 vaccine candidate, named ZyCoV-D.
This approval comes days after DCGI authorised Bharat Biotech’s Covid-19 vaccine candidate for trials.
Zydus developed the Covid-19 vaccine candidate at its Vaccine Technology Centre in Ahmedabad, India.
In animal studies, the vaccine was able to induce a ‘strong immune response’ in multiple species, including mice, rats, guinea pigs and rabbits.
The antibodies generated were observed to completely neutralise the wild type virus when tested using virus neutralisation assay. This is said to indicate the protective potential of the vaccine.
In repeat dose toxicology studies, no safety concerns were reported for the vaccine candidate administrated via intramuscular, as well as intradermal routes.
Zydus added that up to three times the intended human dose was observed to be safe, well tolerated, and immunogenic in rabbits.
The company has already produced clinical GMP batches of the vaccine candidate, with plans to launch the clinical trials this month in more than 1,000 participants at various sites across India.
Zydus said in a statement: “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 company intends to now rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.”
Bharat Biotech received the DCGI approval for its Covid-19 vaccine candidate, Covaxin, to enter Phase I and II studies, which are expected to begin this month.
Covaxin is an inactivated vaccine developed in partnership with the Indian Council of Medical Research (ICMR)’s National Institute of Virology.
ICMR is now working to expedite the trials and contacted 12 institutes to fast track the studies, with an aim to launch the results by 15 August this year.