Zydus Cadila on Friday announced that its plasmid DNA vaccine candidate for COVID-19 (ZyCov-D) has received permission from Drug Controller General of India-Central Drugs Standard Control Organisation (CDSCO) to begin human clinical trials in Phase I/II in India.
The vaccine candidate ZyCov-D has been developed originally at the company’s research centre-Vaccine Technology Centre (VTC) in Ahmedabad, India.
The vaccine when tested on animals brings out a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced due to the vaccine were able to completely neutralise the wild type virus. The vaccine was well-tolerated and was found immunogenic when the dose was tripled in rabbits. It was found safe by both intramuscular and intradermal routes in the toxicology studies.
Zydus till now has manufactured clinical good manufacturing practice (GMP) batches of the vaccine candidate and plans to begin the clinical trials in July 2020 across the country in multiples locations with over 1,000 subjects.
Besides, the company also determines to ramp-up its production capacity of ZyCov-D at multiple facility centres so as to cater to Indian and global demand.
At 10.32 am on Friday, the stock of Cadila Healthcare Ltd was trading at Rs 366 with a growth of 0.76 per cent on BSE.