Hyderabad-based Biological-E will reserve 30 crore of COVID-19 vaccine doses after the Indian government decided to make an advance payment to the vaccine manufacturer. These vaccine doses will be manufactured and stockpiled by Biological-E from August-December 2021. The health ministry will making an advance payment of Rs. 1500 crore to the company.
Biological-E’s covid vaccine is currently undergoing Phase-3 clinical trial after showing promising results in Phase 1 and 2 clinical trials. The vaccine being developed by Biological-E is a RBD protein sub-unit vaccine and could be available in the next few months.
Biological-E’s proposal for vaccine manufacturing in advance was examined and recommended for approval after due diligence by National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), the health ministry said in a statement.
The Indian government also said that the arrangement with Biological-E is part of the wider endeavour to encourage indigenous vaccine manufacturers by providing them support in Research & Development (R&D) and also financial support.
Biological-E covid vaccine candidate has been supported by government preclinical stage to Phase-3 studies. Department of Biotechnology has not only provided financial assistance in terms of grant-in-aid of over ₹100 crore but has also partnered with Biological-E to conduct all animal challenge and studies, the health ministry said.
This has been undertaken as part of Government of India’s ‘Mission COVID Suraksha- the Indian COVID-19 Vaccine Development Mission’ which was launched to reinforce and accelerate COVID-19 vaccine development efforts, the government said.
Under this mission, the government is supporting development of 5-6 COVID-19 vaccine candidates. Some of these are now closer to licensure and introduction in public health systems, according to the government.
“It has not just accelerated COVID-19 vaccine development efforts, but also fostered a robust end-to-end vaccine development ecosystem in the country that will be available for other on-going and future research and developmental activities for other vaccines,” the government said.
Biological-E develops, manufactures and supplies vaccines and therapeutics, suppling its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. According to the company, it currently has 8 WHO-prequalified vaccines in its portfolio.
The Indian government recently said that the country could have as many as 1 crore million doses of COVID-19 vaccines available per day in July and August, compared with under 30 lakh now.
Vaccine manufacturers such as Serum Institute of India and Bharat Biotech are ramping up production to boost supplies while the country is also in talks with major foreign vaccine producers such as Pfizer Inc, officials have said.
Separately, Biological E. has entered into a licensing agreement with Providence Therapeutics Holdings to manufacture the Canadian company’s mRNA COVID-19 vaccine in India.
The Hyderabad-based company will run a clinical trial of Providence’s vaccine in India and seek emergency use approval for it, the company said in a statement.
Biological E also has a separate deal to produce about 60 crore doses of Johnson & Johnson’s COVID-19 shot annually. (With Agency Inputs)
