With the deal sealed, Biological E’s COVID-19 vaccine is set to become India’s second homegrown vaccine to be rolled out.
However, it must be noted that the vaccine has not yet received emergency use authorisation from health authorities.
What do we know about this vaccine? FIT answers your FAQs.
Who is producing the Biological-E Vaccine?
The COVID vaccine is being produced by the oldest private vaccine company in India, Hyderabad based pharmaceutical company, Biological E. The name of the vaccine is yet unknown.
The vaccine was recommended for approval by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), after it was cleared for Phase 3 clinical trials by the Drugs Control General of India (DGCI).
How does it work?
Biological E's COVID vaccine is a protein subunit vaccine.
To put it simply, a subunit vaccine uses only specific components of the pathogen, like particular antigens that best stimulate the desired immune response.
This is a widely used vaccine technology and is known for being very safe.
According to the WHO, owing to its safety, most vaccines in the childhood schedule, including tetanus, whooping cough, meningococcal meningitis are of this type.
Subunit vaccines often require adjuvants that help enhance the body's responses to an antigen, to trigger a strong immune response.
This particular vaccine uses the virus's protein antigen, SARS-CoV-2 Spike RBD, adsorbed to the adjuvant Al hydrogel (Alum), in combination with another approved adjuvant, CpG 1018 to trigger your immune system into action.
What is the status of the vaccine?
According to the Ministry of Home and Family Welfare (MoHFW), this vaccine is in phase 3 of its clinical trials after showing "promising results" in phases 1 and 2.
In these trials, the vaccine was found to be "safe, well-tolerated, and immunogenic."
The phase 3 trials are being conducted on 1,268 healthy subjects, across 15 places in India, in the age range of 18 to 80 years.
When will it be available?
According to the ministry's statement, the Biological E is set to manufacture and stockpile doses of the vaccine between August and December, and the vaccine is likely to be available "in the next few months."
What will the dosage schedule be like?
It is a two-dose vaccine. According to the company, in the clinical trials, the vaccine doses were administered with a gap of 28 days.
Is the government involved in the manufacturing of this homegrown vaccine?
According to a statement by the Ministry of Health and Family Welfare (MoHFW), the government has made an advance payment of Rs 1,500 crore to the company for the production of these vaccines.
“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 support in Research & Development (R&D) and also financial help.”Ministry of Home and Family Welfare
According to the ministry’s statement, the government has provided financial support to Biological-E’s COVID Vaccine from the Preclinical stage to Phase-3 studies.
“Department of Biotechnology has not only provided 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 (THSTI), Faridabad,” read the statement.
Is Biological E manufacturing other vaccines too?
Biological-E is the oldest vaccine manufacturing company in India and makes vaccines for diseases like tetanus, measles, rubella.
Apart from the vaccine in question, Biological-E also has other COVID vaccines in the pipeline.
In May, the company entered a manufacturing contract with Johnson and Johnson to produce their one-shot vaccine in India.
The company aims to produce 600 million doses of the Johnson and Johnson vaccine annually.
On 1 June, the company announced that it has partnered with a Canadian company, Providence Therapeutics Holdings, which will provide the technology needed to manufacture mRNA vaccines in India, with a minimum production capacity of 600 million doses in 2022 and a target capacity of 1 billion doses.
(This was first published on FIT and has been republished with permission.)
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