Phase 1 of human clinical trials of ZyCoV-D Covid-19 vaccine commence

Chandigarh, July 16, 2020: BIRAC has announced that ZyCoVD, the plasmid DNA vaccine designed and developed by Zydus and partially funded by the Department of Biotechnology, Government of India has initiated Phase I/ II clinical trials in healthy subjects, making it the first indigenously developed vac-cine for COVID-19 to be administered in humans in India.

The adaptive Phase I/II dose escalation, multicentric study will assess the safety, tolerability and immunogenicity of the vac-cine.

The human dosing of the vaccine marks a key mile-stone since the launching of the accelerated vaccine development programme for COVID-19 in February 2020.

Dr. Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, “The Department of Biotechnology Government of India has partnered with Zydus to address rapid development of an indige-nous vaccine for COVID-19 under the National Biopharma Mission. This partnership with Zydus is to

serve the country’s need for a vaccine to fight the dread-ed pandemic which has put a billion people at risk. Such research endeavours will help the country to develop preventive strategies for future disease outbreaks as well and exemplifies the government’s focus on cre-ating an ecosystem that nur-tures and encourages new product innovation to make real and measurable changes to issues most relevant to our society.”

She also mentioned that, “This is an important mile-stone for AtmaNirbhar Bharat as Zydus begins human clinical trials for the indigenously developed vac-cine. We hope, that the vac-cine continues to show posi-tive outcomes as it has done so far in the pre-clinical phase where it was found to be safe, immunogenic and well tolerated. This will be a big leap forward for Indian scientific research.”

Speaking on the develop-ment, Chairman of Zydus Cadila, Pankaj R. Patel said, “This is a very important step in our fight against this pandemic and one that will help the nation combat this healthcare challenge. We are thankful to BIRAC and the

Dept of Biotechnology, Government of India for their support in our quest to provide a safe and effica-cious vaccine to prevent COVID 19.”
About ZyCoV-D

In the pre-clinical phase, 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 neutralize the wild type virus in virus neutralization assay indicating the protec-tive potential of the vaccine candidate.

No safety concerns were observed for the vaccine candidate in repeat dose tox-icology studies by both intramuscular and intrader-mal 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 car-rying 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).

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 modi-fy the vaccine in couple of weeks in case thevirus mutates to ensure that the vaccine still elicits protec-tion.

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