Hyderabad: Efficacy of Covaxin will be known only after two doses are administered in all 25,800 human volunteers. The data will be available by March 2021 while doubts are being raised on the ‘clinical trial mode’ approval by the Drugs Controller General of India.
The term ‘clinical trial mode’ has raised doubts in the minds of scientists as to why a vaccine is being given permission without the completion of human trials.
Clarifying on the permission by DCGI, Dr Krishna Ella, chairman of Bharat Biotech says, “All those who having Covaxin jabs will be monitored. Healthcare workers will be the first to have the jabs and this will be a parallel trial.”
In the clinical trial mode, children above 12 years will also be given the vaccine and their observations and results recorded.
Emergency Use Authorization for a vaccine has been given for the first time in India. The rules of DCGI had been amended in 2009 when the first SARS-Cov 1 was notified in China. From…