Hyderabad-based pharmaceutical company Biological E Limited (BE) is all set to provide the cheapest Covid-19 vaccine in India. It is being said that two doses of Corbevax will cost Rs 500. Its clinical phase III trials are currently underway after getting approval from the the Central Drugs and Standards Control Organisation (CDSCO). It is yet to get emergency use approval in the country to fight against coronavirus pandemic.
The firm had started the Phase I/II clinical trials of its Covid-19 subunit vaccine candidate in the second week of November 2020 and has now completed them. According to the Union health Ministry, Biological E would supply 30 crore doses of its vaccine between August and December this year.
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. It is intended to be part of a larger global Phase III study.
Phase I/II Clinical Trials
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.
Result of Phase I/II Trails
Biological E Limited’s Covid-19 vaccine was found to be safe and well tolerated and immunogenic, the release said. Mahima Datla, Managing Director, BE, had said “We are delighted with the success of the Phase I/II clinical trials of our Covid-19 vaccine candidate. The results of these clinical trials are very positive and promising. We believe that our vaccine candidate will become another effective global Covid-19 vaccine as we move forward into Phase III clinical trials."
Biological E Vaccine Rollout in India
Biological E Ltd has started Phase III trials of its vaccine and planned to produce 75 million to 80 million doses a month from August, its managing director had said on May 7, 2021. Government officials had said that the vaccine could be rolled out in the country from August. Datla said Biological E. would apply for emergency use authorisation (EUA) for the drug based on government advice. Production “from August but EUA depends on the government. Will follow their advice and directives," she had told Reuters. “75-80 million doses a month from the time of launch."
Price of Corbevax vaccine
The Bio E company had said that its vaccine will be “one of the most affordable” options in India, according to a media report. Datla had told The Times of India that while she is “not at liberty to share" details of pricing as it is still being worked out, “I can assure you it will be among the most affordable Covid-19 vaccines that you can get a hold of." She had further sought to assure that the company “will not take advantage of the situation”.
The company had also signed to produce 600 million doses of Johnson & Johnson’s single jab Covid-19 vaccine in India. Notably, Biological E has been promised funding for at least 1 billion doses by 2022-end from the US International Development Finance Corporation under the Quad initiative.