Cadila Healthcare (Zydus Cadila) will soon begin clinical trials on children aged 5 years and above soon for its DNA-plasmid technology-based COVID-19 vaccine, a report said on Monday.
The Ahmedabad-based pharma major is already awaiting approval from the Drugs Controller General of India (DGCI) for ZyCoV-D, the country’s first indigenously developed DNA vaccine candidate, Business Standard reported.
On July 15 the Centre informed the Delhi High Court that the company had concluded clinical trials of ZyCoV-D for the 12-18 age group and that the vaccine could soon be available.
“We now plan to start trials on children aged five years and above if the regulator approves,” the newspaper quoted Sharvil Patel, managing director of Zydus Cadila.
So far, no other vaccine has been approved globally for children below 12 years.
A DNA vaccine carries the genetic code for that part of a virus that triggers the immune system of the body. So when the SARS-CoV2 enters the body, the immune system is already prepared to recognise it and knows how best to fight it.
Zydus says the three-dose vaccine is easy to administer and has to be stored between 2 and 8 degrees Celsius, but remains stable even at room temperature (25 degrees Celsius).
ZyCoV-D has shown a 66.6 per cent efficacy in interim analysis of phase 3 trials, and can be stored at 25 degree Celsius for three months.