Zydus gets nod for human trials of COVID-19 vaccine

Zydus on Friday said it has received approval from authorities to start human trials for its COVID-19 vaccine contender - the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide. The vaccine, ZyCoV-D, showed a "strong immune response" in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus, part of Cadila Healthcare Ltd, said in a statement.

This comes within days of Bharat Biotech's Covaxin vaccine getting approval of the drug regulator to start clinical trials. Over seven vaccines are being researched in India and two of them have got go-ahead to start human clinical trials just this week. Globally, over 100 candidates are being tested on humans but no vaccine has yet been approved.

"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.

ZyCoV-D, developed at the company's Vaccine Technology Centre in Ahmedabad, 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 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, it said.

It 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. It is also known to show much-improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest parts of the country, it said.

"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," it added. The company now intends to rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.