Zydus Cadila receives DCGI nod for human clinical trials

July 3, 2020 0 By FM

Indian drug maker Zydus Cadila (Cadila Healthcare Ltd) said on Friday that its plasmid DNA vaccine candidate for COVID-19 has received approval from the Drug Controller General of India to conduct Phase I/II human clinical trials in India.  The vaccine, code named as ZyCoV-D, which was developed at the company’s Vaccine Technology Centre located in Ahmedabad, has successfully completed the preclinical phase.

The human trials were allowed subsequent to the company’s submission of animal trial data to the regulator—Central Drugs Standards Control Organisation (CDSCO), in which the vaccine candidate was found to be successful with respect to safety and immunogenicity.

The antibodies produced by the vaccine during the animal studies were able to completely neutralise the wild type virus in the virus neutralisation assay indicating the protective potential of the vaccine candidate, the company said in a statment. The company plans to initiate the clinical trials in July across multiple sites in India in over 1000 subjects.

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 said the sources. ZyCoV-D is the second COVID-19 vaccine to receive a green light from the DCGI to initiate the human clinical trial in India following that of the Bharat Biotech’s COVAXIN.