India's second coronavirus vaccine set to go into human trial on 1,000 people

India's second possible vaccine against COVID-19, ZyCoV-D, is all set to begin its human trial this month, the company said. It plans to conduct the trials on 1,000 volunteers across multiple sites in the country. In last week of June 2020, Zydus Cadila group received approval from Drug Controller General of India (DGCI) to initiate phase 1 and phase 2 human clinical trials of possible COVID-19 vaccine in India.

Zydus Cadila group chairman Mr Pankaj Patel said the estimated time to finish the trials is around three months. The company will get approval from apex drug regulators to go for phase 3 trials only after it has completed the phase 1 and phase 2 of human trials. "If phase-3 trials come into picture, then it will take another 3 months before the vaccine gets available in the market," Mr Patel said.

The ZyCoV-D vaccine is developed at Zydus' Vaccine Technology Centre in Ahmedabad, show a "strong immune response" in animal studies, the company said. The antibodies produced by the vaccine were able to neutralise the wild type virus in virus neutralisation assay indicating the protective potential of the vaccine candidate, the company said.

So far, no safety concerns were observed for the vaccine candidate in repeat-dose toxicology studies by both intramuscular and intradermal routes of administration.

Zydus added, with its ZyCoV-D, it has successfully established the DNA vaccine platform in India using non-replicating and a non-integrating plasmid carrying the gene of interest making it very safe.

According to the company’s claim, the vaccine candidate has no vector response and with the absence of any infectious agent. The platform offers ease of manufacturing the vaccine with minimal bio-safety requirements, Zydus said. The vaccine has also shown much-improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest parts of the country, it said. "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," it added.

"Before meeting country's demand, we will not start export. However, we may give our technology to other countries so that they can make this vaccine," Mr Patel said.

Another possible vaccine against COVID-19, Covaxin, will soon start human trial on over 1,100 people in two phases, according to a report. Bharat Biotech, an unlisted Indian vaccine maker, received regulatory approval to start human clinical trials for its experimental shot. The phase 1 trial of Covaxine is scheduled to start next week. Around 375 people have been enrolled by the company in the first phase of clinical trials.