Our Indian scientists are leaving no stone unturned to come up with a potential coronavirus vaccine. Just last week, ICMR chief had announced, that India’s first indigenous vaccine “Covaxin” will be ready to fight coronavirus by 15 August 2020. “Covaxin” is developed by BBIL in association with ICMR via a viral strain isolated by National Institute of Virology, Pune.
Moving on the same lines, another Indian candidate for the coronavirus vaccine, got the approval to begin the human trials. Zydus Cadila announced today that it has begun the human trial (Phase I and Phase II) of its potential coronavirus vaccine across multiple sites.
The company says, “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.”
Zydus coronavirus vaccine named “ZyCoV-D” was formulated at the company’s Vaccine Technology Center, Ahemdabad. The company has received the permission from Drug Controller General of India to begin with the Adaptive Phase-I/Phase-II human trials in India. ZyCoV-D coronavirus vaccine is a DNA vaccine which uses non-replicating and non-integrating plasmid to carry the gene of interest. Hence, the vaccine is safe to use.
The company says,”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).”
According to the Clinical Trial Registry of India data (updated on 4 July), in the Phase-I of human trials, the coronavirus vaccine will be tested on the volunteers to determine its safety aspects, and it will take 84 days to complete it. Further, the Phase-II of the human trials will test the vaccine’s safety, efficacy, and also compare it with placebo. This phase of the human trials will again take 84 days to complete.
According to the company’s representative, “In the preclinical 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 protective potential of the vaccine candidate. No safety concerns were observed for the vaccine candidate in repeat dose toxicity studies by both intramuscular and intradermal routes of administration.”
The Ahmedabad site is approved by the CLinical Trial Registry of India for the human trial of Zydus Cadila coronavirus vaccine. Hopefully, we will soon hear more positive updates from the company about the vaccine’s development.