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Ahmedabad Based Zydus Cadila Seeks DCGI Nod For Phase-3 Clinical Trials Of Its COVID-19 Vaccine With 30,000 Volunteers
Zydus
In a positive development, Ahmedabad based pharmaceutical major Zydus Cadila has reached out to the Drugs Controller General of India (DCGI), seeking the nod to begin Phase-III clinical trials of its COVID-19 vaccine candidate called 'ZyCoV-D', reports Times of India.
The plasmid DNA vaccine candidate has been found to be safe, well-tolerated and immunogenic in the Phase-I and Phase-II clinical trials. Now, the company is looking to conduct a massive Phase-III clinical trial of the vaccine with around 30,000 volunteers.
In the Phase-II clinical trial, the company tested the vaccine on over 1,000 healthy adult volunteers as a part of the adaptive Phase-I and Phase-II dose-escalation, multi-centric, randomised and double-blind placebo-controlled study.
"We are optimistic of Phase-III clinical trial outcomes as well and that we would be able to start the production of the Novel Vaccine on its successful completion," Zydus' chairman Pankaj R Patel said.
It should be noted that the company has also claimed that the DNA vaccine platform established by it can also be used to modify the vaccine in a couple of weeks in case the virus mutates.
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