The Ministry of Health has finalized arrangements with Hyderabad-based vaccine manufacturer Biological-E to reserve 30 crore doses of COVID-19 vaccine. These vaccine doses will be manufactured and stockpiled by Biological-E from August to December 2021. For this purpose, the Union Ministry of Health would be making an advance payment of Rs. 1500 crore to Biological-E.
After exhibiting promising results in phase 1 and 2 clinical trials, the Biological-E’s COVID-19 vaccine is presently undergoing phase 3 clinical trials. The vaccine being developed by Biological-E is an RBD protein sub-unit vaccine and is expected to be available in the next few months.
The proposal of Biological-E was examined and recommended for approval after due diligence by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).
The agreement with Biological-E is part of the Indian government’s larger effort to promote indigenous vaccine makers by providing them support in research and development (R&D) as well as financial assistance.
The government of India has supported the Biological-E COVID vaccine candidates from preclinical to phase 3 studies. The Department of Biotechnology has not only provided financial support in terms of grant-in-aid of over Rs 100 crore, but it has also collaborated with Biological-E to undertake all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad.
This has been undertaken under the Government of India’s Mission COVID Suraksha- the Indian COVID-19 vaccine development mission, which was launched as part of the third stimulus package, Atmanirbhar 3.0, to boost and accelerate COVID-19 vaccine development efforts.
The Mission’s major goal is to bring to the citizens a safe, efficacious, affordable, and accessible COVID-19 Vaccine. The mission is to support the development of 5-6 COVID-19 vaccine candidates. Some of these are now closer to avail license and from being introduced in public health systems. It has not just hastened the COVID-19 vaccine development efforts, but also fostered a robust end-to-end vaccine development ecosystem in the nation that will be available for other ongoing and future research and developmental activities for other vaccines.