Hyderabad: Bharat Biotech has recruited 23,000 volunteers and has continued to progress towards achieving the target of 26,000 participants across multiple sites in India for the Phase 3 clinical trial of its COVID-19 vaccine Covaxin, the company said.
Bharat Biotech, along with the Indian Council of Medical Research (ICMR)-National Institute of Virology, is developing Covaxin (NIV).
Covaxin’s Phase III human clinical trials started in mid-November, aimed at 26,000 participants and is the country’s first and only Phase III efficacy study for the COVID-19 vaccine, the vaccine manufacturer said in a press release on Saturday night.
It was also the largest efficacy phase III trial ever performed in India for any vaccine, the company said.
Suchitra Ella, joint managing director of Bharat Biotech, thanked volunteers for their involvement in the trials, and said that the spirit of volunteering is a great moral boost for India and the world.
“We would like to thank all the principal investigators, physicians, medical staff and hospitals for their cooperation and support in advancing the phase III trials of 23,000 Indian volunteers,” she said.
“We are continuing our progress towards achieving the Covaxin Phase 3 clinical trial goal of 26,000 participants,” Ella said.
With positive safety and immunogenicity findings and acceptance in international peer-reviewed scientific journals, Covaxin has been tested in approximately 1,000 subjects in Phase I and II clinical trials.
The indigenous, inactivated vaccine is developed here in the bio-containment facility of Bharat Biotech’s BSL-3 (Bio-Safety Level 3), one of its kind in the world, the company said.
On Saturday, the country’s Central Drug Authority’s expert panel recommended granting authorization for limited use of Covaxin in an emergency situation.
According to the Ministry of Health, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) recommended “granting permission to Bharat Biotech for restricted use in emergency situations in the public interest as an abundant precaution in clinical trial mode, especially in the context of infection by mutant strains.”
According to reports, the committee also confirmed that the firm will continue the ongoing phase 3 clinical trial and send, as and when available, data arising from it. (INN)