The government will make an advance payment of Rs 1,500 crore to Biological E for reserving 300 million vaccine doses. These vaccine doses will be manufactured and stockpiled by Biological E between August and December.
Biological E’s vaccine – a RBD protein sub-unit vaccine – is currently undergoing Phase-3 clinical trials after showing promising results in phases 1 and 2.
The National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) has approved the Biological E vaccine. The MoHWF said this arrangement with Biological E was part of the plans to encourage indigenous vaccine manufacturers by providing them support in R&D and also financial support.
This vaccine candidate had been supported by the government from the pre-clinical stage to Phase-3 studies. The department of biotechnology has not only provided a financial assistance in terms of grant-in-aid of over Rs 100 crore but has also partnered with Biological E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute, Faridabad.
The Phase III clinical study started in April 2021 and is being conducted in 15 sites across India to evaluate the immunogenicity and safety of Biological E’s vaccine for protection against Covid-19 disease in about 1,268 healthy people in the age range of 18 to 80 years.