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 - second Indian pharmaceutical firm to get such d amid a surge in vel coronavirus infections worldwide. vaccine, ZyCoV-D, showed a "strong immune response" in animal studies, and antibodies produced were able to completely neutralise wild virus, Zydus, part of Cila Healthcare Ltd, said in a statement.

This comes within days of Bharat Biotech's Covaxin vaccine getting approval of drug regulator to start clinical trials. Over seven vaccines are being researched in India and two of m have got go-ahe to start human clinical trials just this week. Globally, over 100 candidates are being tested on humans but vaccine has yet been approved.

"Zydus has alrey manufactured clinical good manufacturing practice (GMP) batches of vaccine candidate and plans to initiate clinical trials in July 2020 across multiple sites in India in over 1,000 subjects," company said.

ZyCoV-D, developed at company's Vaccine Techlogy Centre in Ahmedab, has w received permission from Drug Controller General of India (DGCI) - Central Drugs Standard Control Organisation (CDSCO) to initiate phase I/II human clinical trials in India, Cila Healthcare said.

In animal studies, vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. antibodies produced by vaccine were able to completely neutralise wild virus in virus neutralisation assay indicating protective potential of vaccine candidate, it said.

It furr said safety concerns were observed for vaccine candidate in repeat-dose toxicology studies by both intramuscular and intrermal routes of ministration. In rabbits, up to three times intended human dose was found to be safe, well-tolerated and immugenic.

Zydus said, with its ZyCoV-D, it has successfully established DNA vaccine platform in India using n-replicating and a n-integrating plasmid carrying gene of interest making it very safe. company claimed that vaccine candidate has vector response and with absence of any infectious nt, platform provides ease of manufacturing vaccine with minimal biosafety requirements. It is also kwn to show much-improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest parts of country, it said.

"Furrmore, platform can be rapidly used to modify vaccine in a couple of weeks in case virus mutates to ensure that vaccine still elicits protection," it ded. company w intends to rapidly ramp up production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.