Bharat Biotech has announced the successful recruitment of 13,000 volunteers, and continued its progress towards achieving its goal of 26,000 participants for phase-3 clinical test across multiple sites within the country of India’s first Make in India vaccine candidate, Covaxin, against the coronavirus disease (Covid-19).
The phase-3 human clinical trials of Covaxin began mid-November, targeting 26,000 volunteers across the country at multiple sites.
“… this is often India’s first and only Phase-3 efficacy study for a Covid-19 vaccine, and therefore the largest phase -3 efficacy trial ever conducted for any vaccine in India. Covaxin has been evaluated in approximately 1000 subjects in phase I clinical trial and phase II clinical trial clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals,” said the corporate during a statement issued on Tuesday.
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However, Bharat Biotech’s application for emergency use authorisation (EUA) clearance for his or her Covid-19 vaccine candidate remains pending with the national drugs regulator, Drugs Controller General of India, for want of adequate safety and efficacy data.
Covaxin, India’s indigenous Covid-19 vaccine by Bharat Biotech is developed together with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
This indigenous, inactivated vaccine is developed and made in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility, the sole one among its kind within the world.
The vaccine candidate may be a highly purified and inactivated two-dose Sars-CoV-2 vaccine, manufactured during a Vero cell manufacturing platform with a superb safety diary of a minimum of 300 million doses.
“This is an unprecedented vaccine trial ever to require place in India, and that we are overwhelmed with the steady rise in participation. We sincerely thank all the 13,000 volunteers across the country for his or her support in enabling us to bring out a secure and efficacious Indian vaccine for Covid-19. This pro-vaccine public health volunteerism may be a morale building for us to realize our milestone target of 26,000 soon – many thanks volunteers. many thanks India,” said Suchitra Ella, joint director of Bharat Biotech, during a statement.
Prime Minister Narendra Modi visited the Bharat Biotech facility in Hyderabad on November 28 and interacted with the scientists. He congratulated them for the progress that they had made within the vaccine trials.
The Prime Minister’s visit was followed by the visit of as many as 64 ambassadors and high commissioners from several nations to find out more about the add the Bharat Biotech facility to supply a secure and efficacious vaccine against Covid-19.
(With inputs from Srinivasa Rao Apparasu)