After Bharat Biotech India Ltd, Ahmedabad-based Zydus Cadila Healthcare Ltd has been given green signal to conduct phase 1 and 2 clinical trials of its indigenously developed Covid-19 vaccine.
Preclinical studies have shown experimental vaccine produced antibodies against the virus. The company is expected to begin enrollment of subjects soon.
The Drugs Controller General of India (DCGI) gave go ahead to Cadilla to conduct phase I and phase II human clinical trials after animal studies were found satisfactory.
The vaccine approval process was accelerated after recommendation by the subject expert committee on Covid-19.
“The company has submitted data to DCGI based on animal trial, they conducted. Animals like- mice, rabbits, guinea pigs, rats were used and these animals developed antibodies against the virus,” a senior Government official was quoted as saying to an agency.
“Their animal trial data was inspected thoroughly and was found satisfactory. And now, DCGI has granted permission to Zydus Cadila to conduct Phase I & II clinical trial for COVID -19 vaccine on humans after successful animal trial,” the official added.
On Tuesday, 30 June, India’s first Covid-19 vaccine COVAXIN, developed by Bharat Biotech International Limited (BBIL) in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) received DCGI nod to conduct Phase I and II human clinical trials.
Hyderabad based Bharat Biotech said trials of the vaccine are scheduled to begin across India this month. COVAXIN was developed using the SARS-CoV-2 virus strain isolated at NIV, Pune.