Tribune News Service
New Delhi, Jan 2
Amid concerns over the DCGI approvals for Bharat Biotech’s COVID vaccine COVAXIN, which is yet to finish phase 3 trials, the company on Saturday announced successful recruitment of 23,000 volunteers for late stage trials and continued progress towards achieving the goal of 26,000 participants across multiple sites in India.
The phase 3 human clinical trials of COVAXIN began mid-November and targeted 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 India, said the company.
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.
COVAXIN, India’s 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 (Bio-Safety Level 3) bio-containment facility, one of its kind in the world.
COVAXIN is a highly purified and inactivated two dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, said the company.
The platform for COVAXIN development — inactivated virus — is tried and tested from the past, Bharat Biotech added.