Hyderabad-based Bharat Biotech on Wednesday announced that it has entered into a licensing deal with Washington University School of Medicine in St. Louis for a novel chimp-adenovirus, single-dose intranasal vaccine for COVID-19. The Indian Pharma company owns the rights to distribute vaccines in all markets apart from USA, Europe and in Asia, Japan.
The vaccine maker who after completing Phase I at Saint Louis university and receiving required regulatory approval will pursue further stages of clinical trial in India. The company also plans to undertake large scale manufacturing of the vaccine at its GMP facility situated in Genome Valley, Hyderabad.
Bharat Biotech is set to begin the third phase of human trials for its COVAXIN vaccine candidate against SARS-CoV-2, the virus that causes coronavirus disease (COVID-19). The trials will be held at three government medical colleges in Punjab, as per an official statement of Bharat biotech. The Phase 3 trials are slated to begin on 15 October.
The trial will test the safety and efficacy of the shot, and will reportedly be conducted in about 25,000-30,000 volunteers.
The Drugs Controller General of India (DCGI), India’s regulatory agency, granted approval for Phase I and II trials of the vaccine in June. Bharat Biotech, in a partnership with the National Institute of Virology, has concluded phase 1 human trials of their COVAXIN candidate at most of the 12 chosen centres as of 14 August. The results from the preliminary trial suggest that the vaccine is safe so far.
The company is also in talks with other partners and looking at possibilities of manufacturing the vaccine in 4-5 countries. It is looking at having at least 1 billion doses per annum manufacturing capacity of Covaxin.