Now, Zydus Cadila gets DCGI nod for human trials of Covid vaccine

Zydus Cadila intends to now rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand
After Bharat Biotech, now Ahmedabad-based drug major Cadila Healthcare Ltd (Zydus Cadila) has bagged the Drug Controller General of India (DCGI)'s - Central Drugs Standard Control Organisation (CDSCO) nod for initiating phase-I/II human clinical trials for its Covid-19 vaccine.

Zydus Cadila has already successfully completed preclinical phase for its plasmid DNA vaccine candidate ZyCoV-D developed indigenously at its Vaccine Technology Centre in Ahmedabad. According to the company, Zydus has already manufactured clinical GMP batches of ZyCoV-D for human clinical trials and plans to initiate the same this month across multiple sites in the country on over 1000 subjects.

With the Indian Council for Medical Research (ICMR) wishing to launch Covid-19 vaccine for public health by August 15, Zydus Cadila intends to now rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.

Apparently, the vaccine was found to have elicited a strong immune response in multiple species like mice, rats, guinea pigs and rabbits during animal studies. The antibodies produced by the vaccine were able to completely neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate," Cadila Healthcare said in an official communique on Friday.

Moreover, no safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration. On the other hand, up to three times the intended human dose in rabbits were found to be safe, well tolerated and immunogenic, the company stated.

 
With ZyCoV-D, Cadila Healthcare has claimed to have successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe.

In addition, with no vector response and absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1).

"The platform is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest regions of the country. 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," the company further stated.

Earlier, Zydus Cadila was the first company in India to develop and indigenously manufacture the vaccine to combat Swine Flu during the pandemic in 2010. The company's Vaccine Technology Centre has built wide range of capabilities in developing and manufacturing viral, toxoid, polysaccharide, conjugate and other subunit vaccines for unmet needs.

Meanwhile, the company also has a strong pipeline of vaccines like Measles-Mumps-Rubella-Varicella (MMRV), Human papillomavirus vaccine, Hepatitis A, Hepatitis E vaccines which are at various stages of development.


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