Hyderabad-based pharmaceutical company Biological E Limited (BE) received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organisation (CDSCO) – Subject Expert Committee (SEC) late last month. BE 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. The vaccine manufacturer will now conduct the Phase III trials of its candidate. According to the Ministry of Health and Family Welfare, Biological E would supply 30 crore doses of its vaccine between August and December this year.
BE’s Covid-19 Vaccine Candidate
BE’s vaccine candidate includes an antigen developed by the Texas Children’s Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicines integrated commercialization team, along with Dynavax Technologies Corporations advanced adjuvant CpG 1018TM. The vaccine candidate consists of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three-dose level adjuvanted with CpG 1018 plus alum. The Biological E vaccine uses the recombinant-protein technology in which a harmless agent is used to stimulate an immune response in cells. During the trials, the vaccination schedule consisted of two doses for each study participant, administered via intramuscular injection 28 days apart.
Third Phase Trial
The Phase III clinical study will be conducted in 15 sites across India and it will evaluate the immunogenicity and safety of Biological E’s SARS-CoV-2 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 Trial of Biological E Vaccine
The Coalition for Epidemic Preparedness Innovations (CEPI) and the Biotechnology Industry Research Assistance Council (BIRAC) have provided support for the Phase I/II clinical trials and also for the upcoming Phase III trial of this vaccine candidate. BE’s 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
BE’s novel 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
India’s Biological E Ltd will soon start Phase III trials of its COVID-19 vaccine and plans producing 75 million to 80 million doses a month from August, its managing director said on May 7, 2021. Government officials have said 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 told Reuters. “75-80 million doses a month from the time of launch.”
Price of Bio E Vaccine
The pharma company has said its vaccine will be “one of the most affordable” options in India, according to a Times Of India report. Datla told the paper 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 has 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.