India’s national drug regulation organisation has recently approved 2 vaccines for emergency use, one of which is yet to make it through phase III clinical trial.
The national approval of Covaxin, developed in India by Bharat Biotech, has baffled experts in the field.
“I have never seen anything like this before” says Dr Gagandeep Kang, a renowned virologist and Professor in the Department of Gastrointestinal Sciences at the Christian Medical College, India. “Either you are doing a clinical trial or you are not. I am confused.”
The approval of a vaccine without phase III data is “unconscionable,” says Vineeta Bal, an immunologist at India’s National Institute of Immunology.
The argument for approval as per the Subject Expert Committee (SEC) are as follows: “The data generated so far demonstrates a strong immune response (both antibody as well as T cell) and in-vitro viral neutralization. The ongoing clinical trial is a large trial on 25,800 Indian subjects in which already 22,000 subjects have been enrolled including subjects with comorbid conditions as well which has demonstrated safety till date,”
The candidate was approved for restricted emergency use by the Drug Controller General of India (DCGI) Dr V.G Somani the following morning.
The health ministry in India has announced that it will be ready to roll out the Covid-19 vaccine by next week.