Union Ministry of Health has finalised arrangements with Hyderabad based vaccine manufacturer Biological-E to reserve 30 crore of COVID-19 vaccine doses. These vaccine doses will be manufactured and stockpiled by M/s Biological-E from August-December 2021. For this purpose, the Union Ministry of Health would be making an advance payment of Rs. 1500 crore to M/s Biological-E.
The COVID-19 vaccine of Biological-E 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 is likely to be available in the next few months.
The proposal of M/s Biological-E was examined and recommended for approval after due diligence by National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).
The arrangement with M/s Biological-E is part of the wider endeavour of Government of India 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 of India from Preclinical stage to Phase-3 studies. Department of Biotechnology has not only provided financial assistance in terms of grant-in-aid of over Rs 100 cr but has also partnered with Biological-E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad.
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 as part of the third stimulus package, Atmanirbhar 3.0.
The Mission aims to bring to the citizens a safe, efficacious, affordable and accessible COVID-19 Vaccine. The Mission is supporting development of 5-6 COVID-19 vaccine candidates. Some of these are now closer to licensure and introduction in public health systems. 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.