Drugs Controller General of India (DCGI) has given nod to Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials

New Delhi: The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of the Oxford University developed Covid-19 vaccine candidate in the country.

The approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr V G Somani after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on Covid-19.

Covid-19 vaccine"As per the study design, each subject will be administered two doses four weeks apart following which the safety and immunogenicity will be assessed at predefined intervals," the official said.

Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.

According to the revised proposal by the SII, 1,600 people aged above 18 years will participate in the trials across 17 selected sites.

Covid-19 vaccine

The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for Covid-19 had submitted its first application to the DCGI on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine.

Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the UK showed that it has an acceptable safety profile.