The Central Drugs Standard Control Organisation (CDSCO) has given permission to the Hyderabad-based pharmaceutical company Biological E Limited (BE) to start the Phase III clinical trial. In the second week of November 2020, Biological E had started the Phase I and II clinical trials of its Covid subunit vaccine candidate 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 is expected to produce 30 crore doses, Zydus Cadila 5 crore, Serum Institute of India 20 crore doses of Novavax, and Bharat Biotech 10 crore doses of its nasal vaccine, while Genova will make available 6 crore doses and Sputnik V 15.6 crore doses.
Who are the Biological E’s Covid-19 vaccine candidates?
The vaccine candidates of Biological E, Zydus Cadila, Genova, Bharat Biotech's nasal vaccine are in various stages of clinical trials.
It 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 a three-dose level adjuvanted with CpG 1018 plus alum. It uses 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.
The Phase III clinical study will be conducted in 15 sites across India:
According to reports, it will evaluate the immunogenicity and safety of Biological E’s SARS-CoV-2 Covid-19 vaccine. It will be done to access its 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.
Biological E Vaccine Rollout
India’s Biological E Ltd will soon start Phase III trials of its Covid-19 vaccine and plans to produce 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 authorization (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
According to a Times Of India report, the pharma company has said its vaccine will be “one of the most affordable” options in India. 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.