The Ahmedabad-based drug maker will submit the results of its phase-2 trials next week, which “will ascertain the safety, dose and efficacy of the potential vaccine”, said the person who requested not to be identified.
Subsequently, Zydus will apply for phase-3 trial which it plans to conduct on 39,000 participants in December. “If all goes well, the company expects to introduce the vaccine by March next year,” the person said.
Zydus has conducted phase-2 trials on 1,000 participants. Preliminary results show that it is safe as no safety concerns have been observed so far, people tracking the trials said. “The indications are safe and the trial is under control,” one of them said.
In a recent interview with ET, company chairman Pankaj R Patel had said, “We could be looking at manufacturing 100 million doses to begin with, once the vaccine receives all regulatory permissions.”
Zydus’ vaccine technology centre (VTC) has in place the facilities for this, people aware of the matter said. The company is also exploring collaborations to make the vaccine available on a larger scale if need be, they said.
Zydus had initiated phase-1 and 2 trials in July.
With ZyCoV-D, Zydus has established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest, making it safe.