Bharat Biotech’s ‘Covaxin’ Expected to Be Launched by June 2021
India’s Bharat Biotech has said that its COVID-19 vaccine candidate, Covaxin, is likely to be launched by June 2021.
A top official from India’s Bharat Biotech has said that its COVID-19 vaccine candidate, Covaxin, is likely to be ready for launch by June 2021, unless the government advances it through emergency use authorisation, The Indian Express reported on Friday, 23 October.
The Hyderabad-based firm has received approval from the Drugs Controller General of India (DCGI) for phase-3 clinical trials and plans to enrol “25,000 to 26,000” volunteers for the country’s first indigenous candidate, confirmed Sai Prasad, executive director, Bharat Biotech International Ltd.
“If we get all the approvals in place, I think during Q2 of 2021, we should get the efficacy readout from our phase-3 clinical trial — April, May, June, for example. That is for the full efficacy results.”Sai Prasad to The Indian Express
He also conveyed that the firm is committed to doing all the phase 1, phase 2 and phase 3 clinical trials in their entirety, although the government may consider emergency use approval. The firm, however, is not pushing for one.
“Our intent is to develop everything to its logical conclusion in terms of empirical evidence and data, and efficacy data and safety data. But there are discussions, I guess, within the government about that (emergency use approval),” he said.
The trials will involve over 20,000 volunteers tested in various states like Telangana, Tamil Nadu, Haryana, Maharashtra and Bihar. The target is around 25 clinical trial sites.
“For the last two months, we have been trying to establish and develop these sites…across 12 to 14 states in India as of now…it’s well spread between north, south, east and west.”Sai Prasad
The first two phases were conducted across 12 sites.
“There will be quite a few new sites and there will also be quite a few new states, because the site selection for phase-3 is completely different from a phase-1 or a phase-2. We are looking at, obviously, the capabilities and expertise of the site, but also at what’s happening in terms of Covid-19 disease in those respective areas…it’s a multifaceted approach to select a site,” he said.
Currently, India’s indigenous vaccines include Bharat Biotech’s COVAXIN in collaboration with the Indian Council of Medical Research (ICMR) and another by Zydus Cadila Ltd.
It is important to note here that ICMR had, on 3 July, said that Covaxin will be launched by 15 August, a claim which was termed ‘unrealistic’ and ‘unlikely’ by experts even then. In a press release that followed, the nodal research body clarified that its vaccine process was ‘exactly in accordance with globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel’, and that there would be no compromise on safety and efficacy.
What is an Inactivated Vaccine?
The SARS-CoV-2 strain for Covaxin isolated in NIV, Pune and transferred to Bharat Biotech, and then the inactivated vaccine developed and manufactured in their High Containment facility in Hyderabad.
An inactivated vaccine or a killed vaccine uses the killed version of the pathogen that causes the disease. They are made from viruses or bacteria that have been killed clinically and therefore they cannot cause diseases anymore, according to WHO.
Inactivated whole-cell vaccines often cannot produce an immune response or if they do, the response will be short-lived. You may need many doses of the inactivated vaccine to provoke a sufficient response. Comparatively, vaccines made from live viruses are often more powerful at provoking immunity.
On the plus side, since they are inactive, they pose no danger of disease and are safe and stable.
Currently, 198 vaccine candidates are in several stages of clinical research according to the World Health Organisation. Out of these, 44 vaccine candidates are in clinical evaluations and 154 candidate vaccines are in preclinical evaluation. You can read more about them here.
(With inputs from The Indian Express)
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