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Bharat Biotech’s Phase 3 Covid-19 Vaccine Trials Cross Half the 13,000 Volunteer Mark


Bharat Biotech announced the successful recruitment of 13,000 volunteers and continued its progress towards achieving its goal of 26,000 participants for the in-country multi-site phase 3 clinical trial of India’s first Make in India vaccine candidate, Covaxin, against coronavirus disease (COVID-19).

Phase 3 human clinical trials of Covaxin began in mid-November and targeted 26,000 volunteers from across the country at various sites.

“… This is India’s first and only phase 3 efficacy study for a Covid-19 vaccine, and the largest phase 3 efficacy trial ever conducted for any vaccine in India. Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising results for safety and immunogenicity, with acceptance in international peer-reviewed scientific journals, ”the company said in a statement issued Tuesday.

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However, Bharat Biotech’s emergency use authorization (US) application for its Covid-19 vaccine candidate is still pending with the national drug regulator, India’s Comptroller General of Medicines, due to lack of adequate safety data. and efficiency.

Covaxin, Bharat Biotech’s indigenous Covid-19 vaccine from India is developed in collaboration with the Indian Council for Medical Research (ICMR) – National Institute of Virology (NIV).

This indigenous inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) biocontainment facility, the only one of its kind in the world.

The candidate vaccine is a highly purified and inactivated two-dose Sars-CoV-2 vaccine manufactured on a Vero cell manufacturing platform with an excellent safety record of at least 300 million doses.

“This is an unprecedented vaccine trial to be conducted in India, and we are overwhelmed by the steady increase in participation. We sincerely thank the 13,000 volunteers across the country for their support in enabling us to bring out a safe and effective Indian vaccine for Covid-19. This public health volunteering for vaccines is a moral boost for us to achieve our historic goal of 26,000 soon. Thank you volunteers. Thank you India, ”Suchitra Ella, Deputy Managing Director of Bharat Biotech, said in a statement.

Prime Minister Narendra Modi visited the Bharat Biotech facility in Hyderabad on November 28 and interacted with scientists. He congratulated them on the progress they had made in vaccine trials.

The Prime Minister’s visit was followed by the visit of up to 64 ambassadors and high commissioners from various nations to learn more about the work at the Bharat Biotech facility to produce a safe and effective vaccine against Covid-19.

(With input from Srinivasa Rao Apparasu)

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