Hyderabad-based pharmaceutical company Biological E Limited (BE) has said the Phase III trials of its vaccine CORBEVAX is currently underway and the firm expects to apply for emergency use authorisation by August 21. The company said it will supply a minimum of 300 million doses of vaccine to the Central government on obtaining that Emergency Use Licence (EUL), which it hopes to secure by September 21.
In an exclusive interview to CNBCTV-18, Biological E said its major subject recruitment, interim safety and immunogenicity data will be available in August. The Phase III clinical study is being conducted in 15 sites across India and it will evaluate the immunogenicity and safety of Biological E’s Covid-19 vaccine for protection against the disease in about 1,268 healthy subjects in the age range of 18 to 80 years.
The firm has started at-risk drug substance manufacturing of CORBEVAX and expects to fill at a rate of 75 million doses per month at the time of launch. It further said the country can anticipate 100 plus million doses per month starting February 2022.
It is being said that two doses of Corbevax will cost Rs 500. As per reports, Corbevax vaccine has shown promising results in Phase 1 and 2 clinical trials. The vaccine is a RBD protein sub-unit vaccine and is likely to be available in the next few months.
The Coalition for Epidemic Preparedness Innovations (CEPI) and the Biotechnology Industry Research Assistance Council (BIRAC) had provided support for the Phase I/II clinical trials and has also supported the ongoing Phase III trial of this vaccine candidate. Phase I/II clinical trial evaluated the safety and immunogenicity of the vaccine candidate in about 360 healthy subjects in the age range of 18 to 65 years.