Recently, Bharat Biotech has declared the effective enrolment of 13,000 volunteers. It is continuously working towards realizing its target of 26,000 volunteers for phase-3 clinical trial across numerous places in the country of India’s first Make in India vaccine candidate, Covaxin, against the coronavirus disease (Covid-19). With a target of 26,000 volunteers across the country at multiple sites, the phase-3 human clinical trials of Covaxin started mid-November.
According to an official statement, the company stated that it is India’s first and only Phase-3 efficacy study for a Covid-19 vaccine. It further added that for any vaccine in India, it is also the largest phase -3 efficacy trial ever conducted. In Phase 1 and Phase 2 clinical trial, Covaxin has been tested in about 1000 subjects. Nevertheless, for want of appropriate safety and efficacy data, Bharat Biotech’s application for emergency use authorisation (EUA) clearance for their Covid-19 vaccine candidate is still pending with the national drugs regulator, Drugs Controller General of India.
With an exceptional safety track record of at least 300 million doses, the vaccine candidate is an extremely sanitized and inactivated two-dose Sars-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform. On November 28, Prime Minister Narendra Modi visited the Bharat Biotech facility in Hyderabad. There he had interacted with the scientists. He commended them for the progress they had made in the vaccine trials.
After the Prime Minister’s visit, 64 ambassadors and high commissioners from several nations had also visited the facility. They wanted to know more about the work in the Bharat Biotech facility to produce a safe and efficacious vaccine against Covid-19.