In a major feat for Indian pharma major Zydus Cadila (Cadila Healthcare Ltd), the Drug Controller General of India — Central Drugs Standard Control Organisation has granted the company permission to initiate phase-I/II human clinical trials for its plasmid DNA vaccine candidate for Covid-19.
The company on Friday said that its plasmid DNA vaccine candidate ZyCoV-D, developed indigenously at its Vaccine Technology Centre in Ahmedabad, has successfully completed the pre-clinical phase.
For the human clinical trials, Zydus has already manufactured clinical 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.
“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 neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate,” Zydus said in a statement.
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.
With ZyCoV-D, the Company has 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.
“Further, no vector response and with absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1),” it added.
“The platform is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to the 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 statement said.
The company intends to now rapidly ramp up production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.
Zydus’ Vaccine Technology Centre has a wide range of capabilities in developing and manufacturing viral, toxoid, polysaccharide, conjugate and other subunit vaccines for unmet needs. Zydus was the first company in India to develop and indigenously manufacture the vaccine to combat Swine Flu during the pandemic in 2010.
The company also has a strong pipeline of vaccines, for Measles-Mumps-Rubella-Varicella (MMRV), Human papillomavirus, Hepatitis A and Hepatitis E, which are at various stages of development.