Union Govt gives green signal for Bio-E - second 'Desi' vaccine after Covaxin

Union Ministry of Health has finalised arrangements with Hyderabad based vaccine manufacturer Biological-E to reserve 30 crores of Bio-E Covid-19 vaccine doses. M/s Biological-E will manufacture and stockpile these vaccine doses from August-December 2021. For this purpose, the Union Ministry of Health will be making an advance payment of ₹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 an RBD protein sub-unit vaccine and is likely to be available in the next few months. The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) examined and recommended the proposal of M/s Biological-E for approval after due diligence. 

The arrangement with M/s Biological-E is part of the wider endeavour of the Government of India to encourage indigenous vaccine manufacturers by providing them support in Research and Development (R&D) and also financial support. The Government of India has supported Biological-E Covid vaccine candidate from the pre-clinical stage to Phase-3 studies. Department of Biotechnology has provided financial assistance in terms of grant-in-aid of over ₹100 crores. 

India's Second Desi Vaccine Is On The Anvil From Hyderabad

It 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 the 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 the 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 ongoing and future R&D activities for other vaccines.

BACKGROUND TO BIO-E

During the Covid-19 pandemic, the company signed a pact with Baylor College of Medicine and Dynavax Technologies to manufacture a Covid-19 vaccine. The vaccine Bio E Covid-19 is expected to roll out in August with 75 to 80 million doses manufactured per month; the production expected to reach 1 billion by the end of 2022 under the Quad initiative. In August 2020, the company signed a deal with Johnson & Johnson to manufacture the latter's vaccine candidate at its Hyderabad facility.