Potential COVID-19 vaccine by Zydus Cadila gets DCGI nod for human clinical trials

A potential COVID-19 vaccine indigeusly developed by Ahmedab-based Zydus Cila Healthcare Ltd has got d from Drugs Controller General of India (DCGI) for human clinical trials, according to a government source.

approval process was fast-tracked following recommendation by subject expert committee on COVID-19, considering emergency and unmet medical need during pandemic.

"DCGI Dr V G Somani has given approval for phase I and II clinical trials (on humans) of potential vel coronavirus vaccine developed by Zydus Cila Healthcare Ltd on Thursday after its animal studies were found to be successful," an official source in kw of developments told PTI.

assent for human trials was given after company submitted data of clinical trial on animals to DCGI, in which vaccine candidate was found to be successful with respect to safety and immugenicity, source said.

company is likely to start enrolment of subjects soon.

" phase I and II trials will take around three months to be completed," source said.

country's 'first' indigeus COVID-19 vaccine candidate Covaxin, developed by Hyderab-based Bharat Biotech in collaboration with Indian Council of Medical Research and National Institute of Virology (NIV), h recently got d for human clinical trials from DCGI.

India's COVID-19 tally rose to 6,04,641 on Thursday with a single-day increase of 19,148 cases, just five days after it crossed five-lakh mark, while death toll rose to 17,834 with 434 new fatalities, according to Union Health Ministry.