COVAXIN (phase III) clinical trial and its efficacy


The COVAXIN vaccine, developed by the Indian Council of Medical Research (ICMR) in collaboration with Bharat Biotech International (BBIL), has an interim efficacy of 81 percent in preventing COVID-19, according to phase III findings.

The Phase III trial, which began in mid-November 2020 and was co-led by ICMR and BBIL, enrolled a total of 25,800 people across 21 sites.The interim efficacy pattern of 81%, as determined by the DCGI protocol, puts it on par with other global front-runner vaccines.

“The bench-to-bedside journey of a fully indigenous COVID-19 vaccine in less than eight months demonstrates Atmanirbhar Bharat’s [self-reliant India’s] tremendous strength to overcome obstacles and stand tall in the global public health environment.
The COVAXIN vaccine is the first COVID-19 vaccine produced entirely in India. Following the effective isolation of the SARS CoV-2 virus at the ICMR-National Institute of Virology (NIV) in March 2020, ICMR and BBIL established a public-private partnership to grow the virus isolate into a viable vaccine candidate.
Preclinical trials in small animals and hamsters showed that the drug is safe and immunogenic. COVAXIN’s protection and defensive efficacy were also demonstrated in rhesus macaques in subsequent studies.
The candidate vaccine showed a high safety profile in Phase I and Phase II clinical trials, with seroconversion rates of 98.3 percent and 81.1 percent on days 56 and 104, respectively.
“The invention of COVAXIN means that India has a strong tool in its pandemic arsenal, and it will go a long way toward assisting us in winning the war against COVID-19. Dr. Samiran Panda, Head, Epidemiology and Communicable Disease, ICMR, said, “The need of the hour is to ensure that people in India continue to receive the vaccine and break the chain of virus transmission.”