The Drugs Controller General of India (DCGI) on March 11 amended its emergency use approval to Bharat Biotech's COVID-19 vaccine Covaxin by dropping the 'Clinical Trial Mode' label.
Based on the recommendations of the Subject Expert Committee (SEC), the DCGI said the permision is amended to read as "this permission is for restricted use in emergency situation in public interest."
The DCGI asked Bharat Biotech to continue ongoing Phase III clinical trial as per approved clinical trial protocol and submit a revised summary of product characteristics, prescribing information, and the fact sheet.
On Wednesday, an expert panel had recommended the removal of the “clinical trial mode” label attached to the emergency authorisation of Covaxin.
The SEC noted that the firm has carried out interim analysis after 43 cases of symptomatic RT-PCR positive COVID-19 have been reported out of which 36 were in the placebo arm and seven in the vaccine arm. As per interim data from late-stage clinical trials, Covaxin had an efficacy of 80.6 percent.
After detailed deliberation, the SEC has recommended the omission of the clinical trial mode label restriction.
The DCGI amendment would mean that the vaccine can be administered with less stringent conditions and might lead to an increase in the uptake of the vaccine.
Currently, those receiving Bharat Biotech’s Covaxin are asked to sign a consent form before being vaccinated. The screening and consent form adds that compensation for serious adverse events will be paid by the company if it is proven to be causally related to the vaccine.
