Drug Controller General of India approves Coronavirus vaccine by Ahmedabad-based ZydusCadila Healthcare Ltd. for human clinical trials. The nod came after recommendation by the subject expert committee as approved by the Govt. authority. The approval has only come after ZydusCadila submitted data of clinical trial on animals to the DCGI, in which the vaccine candidate was found to be successful with respect to immunogenicity and safety.
The company is likely to start enrolment of subjects soon.
“The phase I and II trials will take around three months to be completed,” the source said.
Coronavirus Vaccine Gets a Green Light
Till date, India has two indigenous manufacturers for the potential COVID-19 vaccine. Earlier, Bharat Biotech International Limited (BBIL) was granted the permission by DGI to start Phase 2 testing. BBIL has partnered with the Indian Council of Medical Research (ICMR) to conduct Phase I & II human clinical trials to develop COVAXIN – indigenous vaccine for coronavirus. The Bharat Biotech is making use of virus strain insulated at ICMR’s National Institute of Virology (NIV), Pune to develop the vaccine.
Human clinical trials are scheduled to start across the country in July for the vaccine. The vaccine was firstdeveloped and manufactured in Bharat Biotech’s facility at Genome Valley in Hyderabad, India.
India, which lags behind the United States, Brazil and Russia in total cases, has reported 627,168 cases.More than 18,000 people have died from the disease since the first case in India in January. It has become crucial for the healthcare system to manage the increasing Covid-19 cases, and the need for a vaccine to control the rising numbers has taken precedence over everything.
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