New Delhi: The Indian Council of Medical Research (ICMR) has said that India made Covaxin for coronavirus pandemic has drawn global attention.
The ICMR took to Twitter and wrote, “India’s indigenous vaccine against #COVID19 Covaxin-a product of ICMR-Bharat Biotech collaboration, achieves the remarkable feat. Data generated from within India underlines the impressive safety and immunogenicity profile of Covaxin and sparks Lancet’s interest in publishing them.”
The ICMR said, “Encouraging Phase I and Phase II COVAXIN trial results have paved the path for Phase III Clinical Trial in India, which is currently ongoing at 22 sites.”
On Thursday, the All India Institute of Medical Sciences (AIIMS) invited volunteers for the Phase III clinical trial of the Covaxin.
AIIMS said, “AIIMS, New Delhi is a site for COVAXIN Phase III clinical trials. This is a whole-virion inactivated vaccine co-sponsored by the Indian Council of Medical Research (ICMR) and Bharat Biotech.”
Dr. Sanjay K Rai, AIIMS Centre for Community Medicine, said that Phase I/II trials (safety and immunogenicity) have already been completed.
COVAXINTM, 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). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Biosafety Level 3) high containment facility.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020.
After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXINTM, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.