Sources close to the development said that CHL which is also known as Zydus Cadila has tested its vaccine candidate ZyCov-D on more than 1,500 children as part of its ongoing Phase-III clinical trials.
Cadila Healthcare (CHL) is all set to submit the data related to its vaccine candidate ZyCov-D by the end of current month and looking forward for an approval from the concerned authority in June this year.
“Our vaccine trial for ZyCoV-D which is a plasmid DNA vaccine is progressing well. It is by far the largest trial being done in the country right now and we have recruited 28,000 plus volunteers for the vaccine. The Phase III trials of our vaccine will be truly representative of the efficacy of the vaccine against many of the known variants as different variants have surfaced in this wave. So the trial outcomes will have more representative efficacy data than any other vaccine. We are looking to submit the data by the end of May and eventually look for an approval in June,” confirmed Dr Sharvil Patel, managing director of Zydus Group, in a written reply to the Financial Express.
Sources close to the development said that CHL which is also known as Zydus Cadila has tested its vaccine candidate ZyCov-D on more than 1,500 children as part of its ongoing Phase-III clinical trials. According to the sources, ZyCov-D can be given to children as they would be required to get three doses of vaccine. Zydus would have advantage over its competitors if its Covid-19 vaccine works for children as the number of children testing positive for Covid-19 has been on the rise.
A senior official of the company said that other than for above 18 years age, Zydus is also working toward getting approval to administer ZyCov-D to children above the age of 12 years. As on today, no other vaccine has been tested for children and is available in India. Globally Johnson & Johnson was reported to be still waiting for results of clinical trials it carried out for its vaccine on children.
The vaccine candidate ZyCoV-D was found to be safe and immunogenic during the phase-I and II trials. Once the company gets approval, it plans to make up to 240 million doses per annum at its facilities at Ahmedabad and Vadodara. Initially it plans to supply in India, but in future the company also wants to export in other countries.
As per original plans, Zydus was to complete Phase-III clinical trials for its vaccine candidate ZyCov-D by the end of March 2021. However, the company’s research team required a couple of months more to vaccinate more numbers of volunteers.