COVID-19 vaccine by Zydus Cadila gets DGCI approval for human clinical trials

Drugs Controller General of India (DGCI) has given its approval for the human clinical trials to the indigenously developed COVID-19 vaccine by Hyderabad based Zydus Cadila Healthcare Ltd.

The approval process was fast-tracked because of the recommendation by the subject expert committee on COVID-19 who pointed out the emergency and the ongoing unmet medical need amid the pandemic.

The approval for the human trial was given after the company had submitted data of the clinical trials on animals to the DGCI. In the data, the vaccine candidate was found to be successful with respect to safety and immunity.

Central Drug Standard Control Organisation grants approval to #ZydusCadilla to initiate phase I and II human clinical trials in India for its potential #COVID-19 vaccine.

— All India Radio News (@airnewsalerts) July 3, 2020

Key Highlights:

•  VG Somani from DGCI has given his approval to the potential COVID-19 vaccine by Zydus Cadila for phase I and Phase II human clinical trials.

•  The approval was given after the animal studies of the vaccine were found to be successful.

•  Zydus Cadila is most likely to start the enrolment of the subjects soon.

•  As per the sources, phase I and phase II human clinical trial will take around three months to be completed.

Bharat Biotech’s COVID-19 vaccine:

A few days earlier, DGCI had also given its approval to the country’s first indigenous COVID vaccine candidate Covaxin for the human clinical trials. The vaccine has been developed by Hyderabad based Bharat Biotech in collaboration with the National Institute of Virology and Indian Council for Medical Research (ICMR).

In the recent development, ICMR has announced that in collaboration with Bharat Biotech, the COVID-19 vaccine can be launched on August 15, 2020, for public use and it has asked the institutes to fast track clinical trials of Covaxin.