Another Covid 19 Vaccine From India Ready For Human Trials As Zydus Cadila Gets Nod From DGCA

India's second vaccine candidate to enter human trials after the DGCA gives approval to Ahmedabad Based pharma Zydus Cadila.

(Representative Image/ Getty)

New Delhi: Indigenously developed COVID-19 vaccine candidate, ZyCoV-D by Ahmedabad based Zydus Cadila Pharmaceuticals has been given the nod by Drug Controller General of India (DGCI) - Central Drugs Standard Control Organisation (CDSCO) to move to human trials after successfully completely the pre-clinical trials.  After Bharat Biotech’s Covaxin, ZyCoV-D this is the second vaccine from India to more to the human trials phase. According to a PTI report, in a regulatory filing, Zydus said that in the animal studies they found that the vaccine created a strong immune response in multiple animal species like mice, rats, guinea pigs, and rabbits. The antibodies in the vaccine completely neutralised the wild type virus in the virus neutralisation assay and indicated the potential of ZyCoV-D as a strong protective candidate. The filing also said that after repeat administration by both intramuscular and intradermal they found no safety concerns in the toxicology studies. In rabbits, after administering over three times the intended human dose, they found it ‘to be safe, well-tolerated and immunogenic’. The vaccine can also be modified in a couple of weeks in case the virus mutates. The Drug Controller General of India (DGCI) of the Central Drugs Standard Control Organisation (CDSCO) has given the Ahmedabad company to initiate phase I/II human clinical trials in India. "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 according to the PTI report. ZyCoV-D is a DNA vaccine using non-replicating and non-integrating plasmid to carry the gene. The vaccine candidate has no vector response, the absence of any infectious agent makes it safe to be manufactured with minimal biosafety requirements. The filing also said that the improved vaccine stability and lower cold chain requirement makes it easy for transportation to the remotest parts of the country. Zydus Cadila plans to ramp up the production in its various sites to meet the expanding global and Indian demands. In 2010, Zydus was the first company in India to develop and indigenously manufacture a vaccine to combat Swine Flu.  The company has manufactured in the past including tetravalent seasonal influenza vaccine, Inactivated Rabies vaccine (WHO Prequalified), Measles containing vaccines (MR, MMR, Measles), Typhoid conjugate vaccine, etc.