Hyderabad: Bharat Biotech on Friday claimed that the second dose of its Covid vaccine, Covaxin, was successfully administered to 13,000 volunteers in phase 3 trials.
Suchitra Ella, Bharat Biotech International Limited’s Joint Managing Director, thanked the volunteers for their voluntary public health pro-vaccine mission.
The announcement came in the midst of the country’s continued administration of Covaxin in clinical trial mode as part of the national vaccination campaign initiated on January 16 for health care workers.
On January 7, the Hyderabad-based firm revealed that it had completed the recruitment of 25,800 individuals for its Phase 3 trials.
The organization said on January 2 that it had hired 23,000 volunteers. The Drugs Controller General of India (DCGI) authorised its limited use in clinical trial mode the next day.
Covaxin’s phase-3 human clinical trials started in mid-November, with a goal of 26,000 volunteers across India. This is the first and only phase 3 efficacy study in India for the Covid-19 vaccine, and the largest phase 3 efficacy study ever performed in the world for any vaccine.
Covaxin is a highly purified and inactivated 2-dose SARS-CoV2 vaccine developed on a platform for the development of Vero cells with an outstanding safety track record of over 300 million doses.
Bharat Biotech is developing India’s first indigenous Covid-19 vaccine in partnership with the Indian Council of Medical Research (ICMR) National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in the bio-containment facility BSL-3 (Biosafety Level 3) of Bharat Biotech, one of its kind in the world.
In the meantime, the company also announced that Covaxin’s phase 1 clinical trial studies have been published in the prestigious The Lancet Infectious Disease medical journal. The company said this is the first publication of a clinical trial on a vaccine from India called Covid-19. “In this journey, we continue to bring you work that is produced in India on a par with international standards,” Suchitra Ella said.
Thursday’s announcements came in the midst of news that Bharat Biotech began supplying 22 cities across the nation with the second consignment containing over 25 lakh doses of Covaxin. Covaxin is part of the government’s mass vaccination program along with the Serum Institute of India’s Covishield vaccine.
Earlier, the first tranche of 2.4 lakh Covaxin doses was flown to 11 cities on January 13. Covaxin was tested in approximately 1,000 subjects in Phase I and Phase II clinical trials, with positive safety and immunogenicity outcomes, with acceptance in international peer-reviewed scientific journals, the vaccine manufacturer said earlier.
So far, five publications have been developed for product development and clinical trial results, of which four have been approved by international peer reviewed journals and will be published soon, it said. (INN)