Zydus says potential COVID-19 vaccine gets DGCI nod for human trials
"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.
View all Offers
- 27% OFF
Samsung Galaxy M12 (Blue,4GB RAM, 64GB Storage) 6000 mAh with 8nm Processor | True 48 MP Quad Camera | 90Hz Refresh Rate₹ 9499₹ 12999Buy On
- 31% OFF
Apple iPhone XR (64GB) - Black₹ 32999₹ 47900Buy On
- 11% OFF
Samsung Galaxy Z Flip3 5G (Phantom Black, 8GB RAM, 256GB Storage) with No Cost EMI/Additional Exchange Offers₹ 84999₹ 95999Buy On
- 16% OFF
Oppo A16 (Pearl Blue, 4GB RAM, 64GB Storage) with No Cost EMI/Additional Exchange Offers₹ 13490₹ 16990Buy On
- 17% OFF
Redmi Note 10 Lite Aurora Blue 4GB RAM 128GB ROM | Alexa Built-in₹ 14999₹ 15999Buy On
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 a regulatory filing.
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 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 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 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. RKL ANS ANS
(This story has not been edited by Business Insider and is auto-generated from a syndicated feed we subscribe to.)
- A CryptoPunk NFT bought for $74 resurfaced after four years and just sold for $2 million
- Best DIY wallpapers to revamp your house
- India's largest car maker loses nearly two thirds of its profit to chip shortage
- New Range Rover: Check out expected price in India, features and other details
- Softbank will make $250 million by selling a fifth of its stake in Policybazaar