Following criticism, Balram Bhargava, ICMR chief, said that Bharat Biotech’s vaccine had only been cleared in the “clinical trial mode.”
“Permission for restricted use in clinical trial mode has been allowed which means consent of participants has to be taken and there has to be a regular follow up of participants,” Bhargava said at a press conference on Tuesday.
Indian Health Minister Harsh Vardhan also clarified on Twitter that the emergency use approval for COVAXIN was “in clinical trial mode,” wherein all recipients of the vaccine would be tracked and monitored as if they are in trial.
Furthermore, the Health Ministry stressed that this is only an interim approval and the final one follows the completion of trials and the complete availability of data.
But the unusually cryptic language has left experts confused.
“They’ve introduced terminologies that are confusing,” Giridhar Babu, a professor of epidemiology at the Public Health Foundation of India, told Reuters. “The phrase ‘in clinical trial mode’ is not generally a term you will see in approvals.”
This view is shared by Srinath Reddy, president of the Public Health Foundation of India. “The regulator has not made clear what continuation in a clinical trial mode means. It is likely that this vaccine will prove to be effective, but the proof is not there yet, of a completed clinical trial. Let us hope it comes soon,” he told DW.