The Indian Council of Medical Research (ICMR) has said that Covaxin has drawn global attention. Covaxin is a COVID-19 vaccine being developed by ICMR-Bharat Biotech. It is now undergoing phase-3 trials.
The ICMR in a tweet said that India's indigenous vaccine has achieved remarkable feat. Data generated from within India underlines impressive safety and immunogenicity profile of Covaxin and sparks Lancet's interest in publishing them.
"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," the ICMR said.
Meanwhile, All India Institute of Medical Sciences (AIIMS), Delhi has invited volunteers for the Phase III clinical trial of the indigenously developed COVID-19 vaccine candidate Covaxin for which it is one of the sites. "AIIMS, New Delhi is a site for COVAXIN Phase III clinical trial. This is a whole-virion inactivated vaccine co-sponsored by Indian Council of Medical Research (ICMR) and Bharat Biotech," AIIMS said in an advertisement.
AIIMS Centre for Community Medicine, Dr Sanjay K Rai informed through the advertisement that Phase I/II trials (safety and immunogenicity) have already been completed.
According to a PTI report, Covaxin showed long-term antibody and T-cell (immune) memory responses three months after the shot in phase 1 volunteers and tolerable safety outcomes in Phase 2 study, the city-based company has said, suggesting the antibodies may persist for six to 12 months. In phase 2, it also showed enhanced humoral and cell-mediated immune responses and the results were found in the safety and immunogenicity clinical trial of the vaccine candidate.
Memory T cells are antigen-specific T cells that remain over a long term after an infection has been eliminated.