COVID Vaccine: Bharat Biotech Starts Phase III Trials for Covaxin 

26,000 trial volunteers would be receiving two intramuscular injections around 28 days apart.

Updated
Treatment & Vaccine
2 min read
26,000 trial volunteers would be receiving two intramuscular injections around 28 days apart.
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Phase III trials for Bharat Biotech’s indigenous vaccine candidate COVAXIN have commenced across India, the company has announced, making it India’s first phase 3 efficacy study for a COVID-19 vaccine and the largest phase 3 trial ever conducted in India.

26,000 trial volunteers would be receiving two intramuscular injections around 28 days apart, and will be randomly assigned to receive COVAXIN or placebo in a double-blinded study. Those who wish to participate must be over 18 years of age.

The candidate vaccine has already been evaluated in 1,000 participants in the first two stages of clinical trials, in which it presented promising safety and immunogenicity results, the company has said in its press release.

Speaking on the occasion of the commencement, Mrs. Suchitra Ella Joint Managing Director of Bharat Biotech said, “The development and clinical evaluation of COVAXIN marks a significant milestone for vaccinology in India, for a novel vaccine. It is important for Indian companies to innovate and develop indigenous vaccines, especially during a pandemic. COVAXIN has garnered interest from several countries worldwide for supplies and introduction.”

COVAXIN, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

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.

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.

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