This is so far India's largest efficacy trial of any vaccine. Efficacy trials typically check if the vaccine works to prevent disease. About 50 percent of volunteers are given placebo shots and the remaining are given vaccine shots. This data is kept blinded. Once a statistical number of disease cases emerge in the sample, the data is unblinded to analyse the efficacy.
Covaxin is yet to generate any efficacy data and has not submitted any interim analysis data to the SEC. It has proven safety in phase 1 and 2 trials and has also shown efficacy in animal challenge trials (on non-human primates). Its approval in clinical trial mode led to a public debate as the vaccine did not have a proven efficacy. Now when given to any person, one needs to give informed consent, and also would be monitored regularly by the firm.
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). Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.
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