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Bharat Biotech to begin Phase-3 human trials of COVAXIN in Punjab

By Gitanjali Mangal -- September 23, 2020 9:38 pm -- Updated:September 23, 2020 9:38 pm

Bharat Biotech is all set to begin the third phase of human trials for its COVAXIN vaccine against SARS-CoV-2, the virus that causes coronavirus disease (COVID-19).

As per the official statement, the trials will be held at three government medical colleges in Punjab.

The Phase 3 trials are slated to begin on 15 October, according to a report by Asian News International, as disclosed by a government spokesperson after a virtual COVID-19 review meeting chaired by the Punjab Chief Minister Amarinder Singh.

The trial will test the safety and efficacy of the shot, and will reportedly be conducted in about 25,000-30,000 volunteers.

The Punjab CM has strictly instructed the Medical Education and Research Department to ensure full care and strict adherence to all the required precautions during trials, and that mandatory consent of all participants involved in the trial is taken.

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As per the reports, he followed these instructions up with stern directions to ensure the poor are not pulled into trials without consent, knowledge and understanding of the potential repercussions and dangers.

Bharat Biotech recently shared the results of their COVID-19 vaccine candidate safety trials in animals. The experimental shot, called 'COVAXIN', was found safe in rhesus monkeys that were vaccinated and exposed to the SARS-CoV-2.

COVAXIN: AIIMS to start human trials of India's first COVID-19 vaccine  today - Oneindia News

The Drugs Controller General of India (DCGI), India's regulatory agency, granted approval for Phase I and II trials of the vaccine in June. Bharat Biotech, in a partnership with the National Institute of Virology, has concluded phase 1 human trials of their COVAXIN candidate at most of the 12 chosen centres as of 14 August. The results from the preliminary trial suggest that the vaccine is safe.

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According to the reports, the second phase of human trials for the vaccine is likely to begin in the first week of September.

Three government colleges from Punjab to participate in phase 3 trials of  Covaxin | Health Tips and News

COVAXIN is the first indigenously-developed vaccine against coronavirus. It is an inactivated vaccine candidate, designed to produce unique elements of the SARS-CoV-2 virus, which are used by the immune system to recognize a threat if the whole virus in ever encountered in the real world.

-PTC News

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