A new potential COVID-19 vaccine developed by the Ahmedabad-based Zydus Cadila Healthcare Ltd got a nod from Drugs Controller General of India (DCGI) for human trails, after the Bharat Biotech's Covaxin COVID-19 vaccine recently.
The approval process fast-tracked by following the recommendations by the subject expert committee laid for the COVID-19, considering the emergency and unmet medical need of the pandemic at present.
"DCGI Dr V G Somani gave approval for the phase I and II clinical trials (on humans) of the potential novel coronavirus vaccine developed by Zydus Cadila Healthcare Ltd on Thursday after its animal studies were found to be successful," an official source in the know of the developments told PTI.
At first, the company submitted data of clinical trials on animals to the DCGI. The vaccine candidate was found successful with respect to safety and immunogenicity.
"The phase I and II trials will take around three months to be completed," the source added.
India’s first indigenous COVID-19 vaccine candidate Covaxin, developed by Hyderabad based Bharat Bio-Tech on collaboration with the Indian Council of Medical Research and National Institute of Virology got the first nod for the human trail from the DCGI.
India with a record spike of 20,903 new cases in a single day on Friday, touched 6,25,544 cases in total. India reported 379 deaths in the last 24 hours. China and the US are also on the front runners of vaccine trails. Oxford University vaccine received funding and started clinical trials in Brazil.
