Chennai: Over 1,100 people are expected to be enrolled in the first two phases of human clinical trials for COVAXIN – India’s first COVID-19 vaccine candidate, an application by developers Bharat Biotech said.
Phase I clinical trials are scheduled to start next week, with 13 July set as the date for participant enrolment. Results from Phase I will determine the start of the next phase of testing.
Results from Phase I will determine the start of the next phase of testing. The Indian Council for Medical Research (ICMR ) has selected 12 institutes to conduct these trials and directed that these be fast-tracked.
The government has insisted it will release a viable coronavirus vaccine by 15 August. However, this statement has been criticised by experts who say rushing drug trials could pose serious health risks.
The Indian Academy of Sciences (IASc) has said the Indian Council for Medical Research’s (ICMR) target to launch a coronavirus vaccine by 15 August is unfeasible and unrealistic.
The Bengaluru-based body of scientists said while there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner.
In a statement, it said while administrative approvals can be expedited, the scientific processes of experimentation and data collection have a natural time span that cannot be hastened without compromising standards of scientific rigour.