India’s coronavirus vaccine candidate Covaxin has drawn global attention, the Indian Council of Medical Research said on Thursday.
Covaxin is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology. It has recruited 13,000 of the 26,000 volunteers for the ongoing Phase 3 trials, which began in mid-November.
The indigenous vaccine has achieved a remarkable feat, the ICMR said. “Data generated from within India underlines impressive safety and immunogenicity profile of Covaxin and sparks Lancet’s interest in publishing them.”
It added: “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.”
Covaxin has shown long-term antibody and T-cell memory responses three months after the shot was administered to phase 1 trial volunteers, PTI reported on Thursday, citing a research paper published by the Hyderabad-based Bharat Biotech. The results, however, have not been peer-reviewed yet.
T-cells, a type of white blood cell that makes up part of a healthy immune system, are thought to be essential to protect against infection from the SARS-CoV-2, and could provide longer immunity than antibodies. Bharat Biotech said that its indigenous vaccine may persist for six to 12 months. It added that in Phase 2 trials, the vaccine was well-tolerated with no serious adverse events. Covaxin also showed enhanced humoral and cell-mediated immune responses in Phase 2.
The government has not signed a deal for a coronavirus vaccine yet so it is unclear when it will be available for use in the country. It is likely that the Centre may approve some coronavirus vaccines over the next few weeks. The final call on the efficacy of a vaccine will be taken by the Drugs Controller General of India. Several countries such as the US, the United Kingdom, Russia and China have already begun vaccination.
Besides Covaxin, the Covishield vaccine, made by Serum Institute of India, which has partnered with British-Swedish pharmaceutical company AstraZeneca, is a potential candidate that has applied for authorisation. Six other vaccine candidates are also in various stages of clinical trials.
India has so far recorded 1,01,46,845 cases and 1,47,092 deaths. However, less than 3 lakh of the total cases are currently active as over 97 lakh have already recovered from the infection.