India faces harsh criticism on approval of local vaccine for CoVID-19 without having any proof for its efficacy and side effects. The regulatory panel approved the vaccine just one day after the making of vaccine occured.
Subject Expert Committee(SEC) told that Bharat Biotech International Ltd to present more data to show the efficaciousness of the vaccine.
“After detailed deliberation, the committee recommended that the firm may perform interim efficacy analysis for further consideration of restricted emergency use approval,” they told.
On the next day the committee approved the Bharat Biotech vaccine for “restricted use in [an] emergency situation in public interest as an abundant precaution”.
This news faced alot of criticism.
The health professionals questioned the SEC’s abrupt approval of vaccine one day after asking for more data.
“The SEC appears to have been pressured overnight into reconsidering its decision and giving approval the next day, albeit hedged in by many conditions,” the All India People’s Science Network told.
“We are perplexed at the abrupt change in thinking of the SEC from the first two meetings to the third day on which the approval was recommended while apparently discounting the need for efficacy data as the condition of the approval,” the All India Drug Action Network added.
“They’ve introduced terminologies that are confusing,” told Giridhar Babu, a professor of epidemiology.
“The phrase ‘in clinical trial mode’ is not generally a term you will see in approvals.”
Babu told. “It takes decades of work to build confidence in vaccines.”