13,000 volunteers given 2nd dose of Covaxin: Bharat Biotech

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 the country.

Hyderabad: Bharat Biotech on Friday announced that 13,000 volunteers have been successfully administered the second dose of its Covid vaccine Covaxin in the phase-3 trials.

Suchitra Ella, Joint Managing Director, Bharat Biotech International Limited, thanked the volunteers for their pro-vaccine public health volunteerism.

The announcement came amid the continuing administration of Covaxin in the country in clinical trial mode as part of the nationwide vaccination programme launched for healthcare workers on January 16.

The Hyderabad-based firm had on January 7 announced that it completed the recruitment of 25,800 people for its phase 3 trials.

On January 2, the company said that it has recruited 23,000 volunteers. The next day Drugs Controller General of India (DCGI) approved its restricted use in the clinical trial mode.

The phase-3 human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers across India. 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 the country.

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.

India’s first indigenous Covid-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) — National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Biosafety Level 3) bio-containment facility, one of its kind in the world.

Meanwhile, the company also announced that phase-1 clinical trials studies of Covaxin have been published in the prestigious medical journal of The Lancet Infectious Disease. The company said this is the first clinical trial publication on a Covid-19 vaccine from India. “We continue in this journey of bringing you work that is made in India on par with international standards,” said Suchitra Ella.

Thursday’s announcements came amid reports that Bharat Biotech started supply of the second consignment containing over 25 lakh doses of Covaxin to 22 cities across the country.
Covaxin along with Serum Institute of India’s Covishied vaccine are part of the government’s mass vaccination programme.

Earlier on January 13, the first tranche of 2.4 lakh Covaxin doses were flown to 11 cities.

The vaccine maker earlier said 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 product development and clinical trial data thus far has generated five publications, of which four have been accepted by international peer reviewed journals and will be published soon, it had said.