Bharat Biotech on Monday said it has commenced phase III trials for Covaxin, the COVID-19 vaccine candidate being developed in collaboration with the Indian Council of Medical Research (ICMR).
It will involve 26,000 volunteers across India, the first phase III efficacy study and the largest clinical trial for a COVID-19 vaccine in the country. The company said this after Chairman and Managing Director Krishna Ella told a conference, organised by the Indian School of Business (ISB), that the vaccine has entered the phase III trial.
The volunteers will receive two intra-muscular injections approximately 28 days apart. They will be randomly assigned to receive Covaxin or placebo. The trial is double blinded, such that the investigators, the participants and the company will not be aware of who is assigned to which group.
The vaccine candidate has been evaluated in around 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogencity data. Volunteers who wish to participate in this trial should be adults over 18 years of age, the release said.
The phase III study will be conducted at 22 sites across the country. While Nizams Institute of Medical Sciences in Hyderabad is the lone site in Telangana; in Andhra Pradesh the trial will be conducted at Guntur Medical College; and King Gorge Hospital, Visakhapatnam.
In his adddress at ISB’s Deccan Dialogue, Mr.Ella said Bharat Biotech is the only company with BSL-3 (Bio-Safety Level 3) bio containment facility and the inactivated vaccine is developed and manufactured there. The company is also working on a single dose nasal drop vaccine for COVID-19.
A release from ISB said it was the third edition of Deccan Dialogue and organised, on a digital platform, in partnership with Ministry of External Affairs (MEA) on the theme ‘Crisis and Cooperation: Imperative in the times of Pandemic’.
Speaking on health security, Secretary (Economic Relations) in MEA Rahul Chhabra said “nobody is safe until all of us are safe. Health security was not a main table agenda in international discussions, but post the pandemic, it has become the top agenda now.”
Industrialist and Member of ISB’s Executive Board Sunil Kant Munjal said over the years, ISB could institutionalise and create research driven institutions within the School focussed on infrastructure, manufacturing, healthcare and public policy. ISB will be delighted to create a separate centre of excellence on ‘Business and Diplomacy’ in partnership with MEA, he said.