Zydus’ Covid-19 vaccine receives permission to initiate human clinical trials

The company to start human clinical trials in July 2020

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Zydus
Zydus’ Covid-19 vaccine is found to be immunogenic in multiple animal species. Antibodies produced in animal studies are able to completely neutralize the wild type virus. Photo - Zydus

Zydus, a global pharmaceutical company, announced that its plasmid DNA vaccine candidate for Covid-19 (ZyCoV-D) developed indigenously at its Vaccine Technology Centre in Ahmedabad, India has completed the preclinical phase and has now received permission from the Drug Controller General of India – Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I and II human clinical trials in India.

According to the company’s press statement, in animal studies, the vaccine elicits 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 vaccine candidate’s protective potential. 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 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 1000 subjects.
With ZyCoV-D, the company has claimed to successfully establish the DNA vaccine platform in the country using non-replicating and a non-integrating plasmid carrying the gene of interest, making it very safe.

Further, no vector response and with the 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 a couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection.

The company intends to now rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.

Zydus’ Vaccine research program

Vaccine Technology Centre of Zydus Cadila has wide range of capabilities in developing and manufacturing viral, toxoid, polysaccharide, conjugate and other subunit vaccines for unmet needs. Zydus claims to be the first company in India to develop and indigenously manufacture the vaccine to combat Swine Flu during the pandemic in 2010. In past, it has also indigenously developed numerous vaccines successfully including tetravalent seasonal influenza vaccine (first company in India to develop and commercialize indigenously), Inactivated Rabies vaccine (WHO Prequalified), Varicella vaccine (first Indian company to develop and receive market authorization indigenously), Measles containing vaccines (MR, MMR, Measles), Typhoid conjugate vaccine, pentavalent vaccine (DPTHepB-Hib) and others to name a few. 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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