25,800 volunteers enroll for Bharat Biotech’s Covid-19 vaccine’s Phase III trials

The indigenous vaccine has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

The Bharat Biotech International Limited on Thursday announced the successful completion of volunteer enrolment for phase-3 clinical trials of its indigenously manufactured COVID-19 vaccine ‘Covaxin.’

A health worker and participant during a dry run of the Covid-19 vaccination programme in Gurugram.(Parveen Kumar/Hindustan Times)

“Covaxin successfully completes phase 3 clinical trials enrolment of 25,800 volunteers,” Suchitra Ella, Joint Managing Director of Bharat Biotech in a statement while expressing gratitude towards principal investigators and healthcare workers for their support in their public-private partnership vaccine programme.

“My deep appreciation to all the volunteers for reposing trust and expressing pro-vaccine public health volunteerism in the phase-3 clinical trials of India’s 1st fully indigenous COVID-19 vaccine,” Ella added.

The indigenous vaccine has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

COVAXIN has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer-reviewed scientific journals, the company had said in a statement.

COVAXIN is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, it had added.

COVID-19 vaccines of Serum Institute of India’s ‘Covishield’ and Bharat Biotech’s ‘Covaxin’ were granted permission for restricted use in an emergency situation by the Drugs Controller General of India (DCGI) on January 3.

Earlier in the day, Union Health Minister Dr Harsh Vardha said that the COVID-19 vaccines ‘Covishield’ and ‘Covaxin’ are on the verge of being available in the country.The Health Minister, while addressing a press conference, said, “COVID-19 vaccines ‘Covishield’ and ‘Covaxin’ are on the verge of being available in the country. Our efforts are to ensure seamless last mile delivery of the vaccine.”