Covid: Covaxin crosses halfway mark in Phase 3 trial

Bharat Biotech says recruitment for Covid-19 vaccine's Phase 3 trial reaches halfway mark

Covaxin was evaluated in about 1,000 subjects in the Phase I and Phase II clinical trials, with promising safety and immunogenicity results

Representative image. Credit: iStockPhoto

Bharat Biotech has announced the recruitment of 13,000 volunteers, the halfway mark of its Phase-3 clinical trial of Covaxin which began in mid November across multiple centres in India

The total targeted participation of 26,000 volunteers is the largest Phase-3 efficacy trial ever conducted for any vaccine in India. This is India’s first and only Phase III efficacy study for a Covid-19 vaccine, Bharat Biotech said.

"These 13,000 volunteers were given a shot of the vaccine and there has been no adverse event till date,” a company representative told DH.

Covaxin is a highly purified and inactivated two-dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform. It is India's indigenous Covid-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology.

This vaccine is manufactured in Bharat Biotech's Bio-Safety Level 3 biocontainment facility, “one of its kind in the world”, in the Genome Valley on Hyderabad outskirts.

“This is an unprecedented vaccine trial ever to take place in India, and we are overwhelmed with the steady rise in participation. We sincerely thank all the 13000 volunteers across the country for their support in enabling us to bring out a safe and efficacious Indian vaccine for Covid-19,” Suchitra Ella, joint managing director, Bharat Biotech said. “This pro-vaccine public health volunteerism is a morale booster for us to achieve our milestone target of 26,000 soon.”

Covaxin was evaluated in about 1,000 subjects in the Phase I and Phase II clinical trials, with promising safety and immunogenicity results and their acceptance in international peer reviewed scientific journals, BBIL said.

On 28 November, Prime Minister Narendra Modi visited Bharat Biotech, as part of his three city visit to take stock of the Covid-19 vaccine development and manufacturing process.

Earlier this month, a delegation of 64 envoys visited Bharat Biotech and Biological E facilities at the Genome Valley and were apprised of the progress.

The two Hyderabad based companies are involved separately in the development of Covid-19 vaccines.