The availability of COVID-19 vaccinations is critical to meeting the Center's ambitious ambition of vaccinating everyone aged 18 and up by the end of 2021. The government has reserved 30 crore doses of Hyderabad-based Biological-Covid E's jab. The vaccine is still in a clinical trial, in order to meet a strict immunization target. The Health Ministry will give the business an advance of Rs. 1,500 crore for the vaccination, which will be the country's second made-in-India vaccine after Bharat Biotech's Covaxin.
How does the vaccine work?
According to the government, Phase 1 and 2 clinical studies of Biological E's shot showed encouraging results. Phase 3 trials are currently underway. Between August and December, 30 crore dosages will be manufactured and stored.
The yet-to-be-named COVID-19 vaccine is being developed in collaboration with Baylor College of Medicine in Houston. It will be modeled after the Hepatitis E vaccination.
When will it be made available?
The RBD protein sub-unit vaccine being developed by Biological-E is expected to be available in the coming months.
The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) reviewed Biological-request E's and recommended approval following due diligence, according to the statement.
Government Support to the Vaccine Producer
From preclinical to Phase 3 trials, the government has backed the Biological-E COVID Vaccine candidate. Through its Research Institute Translational Health Science Technology Institute, the Department of Biotechnology has not only provided financial assistance in the form of grant-in-aid worth over Rs 100 crore, but it has also partnered with Biological-E to conduct all animal challenge and assay studies.
This is part of the government's 'Mission COVID Suraksha- the Indian COVID-19 Vaccine Development Mission,' which was established as part of the third stimulus package, Atmanirbhar 3.0, to boost and expedite COVID-19 vaccine development activities.
The mission's goal is to provide citizens with a COVID-19 jab that is safe, effective, economical, and readily available. The Mission is funding the development of five to six COVID-19 vaccine candidates. Some of these are on their way to being licensed and implemented in public health systems.
It has not only hastened the development of the COVID-19 vaccine, but it has also cultivated a strong end-to-end vaccine development ecosystem in the country, which will be available for other ongoing and future research and development operations for other vaccinations.
In India, Biological E will also produce two distinct COVID-19 vaccines. The company has a partnership with Providence Therapeutic Holdings in Canada to produce its coronavirus mRNA vaccine, as well as an agreement with Johnson and Johnson to produce its single-dose Janssen jab.
Biological E sells to over 100 countries and manufactures eight World Health Organization (WHO) pre-qualified vaccinations. This includes vaccines for tetanus, measles, and rubella, as well as pentavalent vaccinations and snake anti-venom.
Following its newest partnership with Canada-based biotech business Providence Therapeutics, Hyderabad-based Biological E Limited, India's oldest private vaccine provider, is emerging as a local powerhouse in COVID-19 vaccine manufacturing.
Biological E licensed a recombinant protein COVID-19 vaccine candidate created by Baylor College of Medicine, a Houston-based health sciences university, on August 13 of last year. The technology was passed to Biological E, which will scale up manufacturing and continue to develop the vaccine candidate.
"The deal is for development of an affordable vaccine, especially for India and other low- and middle-income nations," according to Mahima Datla, granddaughter of the company's founders and managing director of Biological E.
The sterile injectable production plant is set across a 14-acre complex and has a built-up area of 39,000 square meters. It has annual capacity of roughly 135 million units and the ability to expand by another 30 million units immediately.