Ahmedabad-based Zydus Cadila Healthcare Limited has got the nod from the Drugs Controller General of India (DCGI) for human clinical trials of its vaccine candidate developed for COVID-19. It is the second indigenous vaccine candidate to get permission for clinical trials. Earlier, Hyderabad-based Bharat Biotech had got the nod for clinical trial of its vaccine candidate ‘Covaxin’.
The approval process was fast-tracked following a recommendation by the subject expert committee on COVID-19, considering the emergency and unmet medical need during the pandemic.
“DCGI Dr V G Somani has given 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 was found to be successful,” sources said
The assent for human trials was given after the company submitted data of clinical trial on animals to the DCGI, in which the vaccine candidate was found to be successful with respect to safety and immunogenicity, sources said.
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.
Notably, the Ministry of Health and Family Welfare has informed that 20,903 fresh cases of novel coronavirus have been reported in India in the past 24 hours ending Friday morning. It is the biggest single-day spike in cases reported in the country that has taken the total COVID-19 case count to 6,25,544.
Also, 379 deaths have been reported in the country during this period that has taken the death toll beyond the 18,000-mark. So far, 18,213 people have succumbed to the deadly virus in the country.