The Union Ministry of Health has reserved 30 crore doses of Covid-19 vaccine that Biological-E (BE) is developing.

“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 Ministry said on Thursday.

The double-dose vaccine candidate of the Hyderabad-based biological products company, said to be the first in the country, is undergoing Phase-3 clinical trials after showing promising results in first two phases.

It includes an antigen in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialisation team, along with Dynavax’s advanced adjuvant CpG 1018 based on a collaboration BE had entered into in November last year.

“It is is a Receptor Binding Domain (RBD) protein sub-unit vaccine and is likely to be available in the next few months,” the Ministry said.

The vaccine will be manufactured and stockpiled by Biological-E from August-December. For this purpose, the Health Ministry would be making an advance payment of ₹1,500 crore to the company.

The vaccine candidate has been supported by Government from the pre-clinical stage to Phase-3 studies.

The Department of Biotechnology has not only provided a grant-in-aid of over ₹100 crore, but also partnered with Biological-E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad.

The arrangement with Biological-E is part of the government’s wider endeavour to encourage indigenous vaccine-makers by providing them Research & Development and financial support.

This is also part of the Centre’s ‘Mission Covid Suraksha to develop a vaccine, which was launched as part of Atmanirbhar 3.0 package.

Other vaccines

In addition, Biological E has already entered into collaboration with few other global players for the Covid vaccine. Earlier this week, it tied up with Calgary-based Providence Therapeutics to manufacture its mRNA technology-based vaccine and undertake clinical trials in India.

Besides, it already has a deal to make over 500 million doses of the single-dose Johnson and Johnson vaccine. J&J’s is a viral vector based vaccine that uses human adenovirus Ad26.

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