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NEW DELHI : A committee of subject matter experts (SEC) of the drug regulator recommended on Wednesday removing the ‘clinical trial mode’ condition from the emergency use license granted to the covid-19 jab Covaxin, said two people familiar with the development , probably improving its chances of acceptability.
Covaxin, developed by Bharat Biotech International, is one of two government-approved covid-19 vaccines, but controversially, this approval for Covaxin was granted despite the developers’ inability to submit data from the phase trials. 3.
However, on March 3, the company submitted “interim” (not peer-reviewed) phase 3 trial data to the regulator, which showed the vaccine was 80.6% effective.
The SEC’s recommendation, if accepted, will mean that those taking the vaccine will no longer have to give informed consent. This, in turn, could give the locally developed vaccine greater acceptability and help to erase some of the doubts surrounding it.
The SEC is tasked with scrutinizing covid-19 diagnostic, vaccine and drug applications. Their recommendations are generally accepted to the Comptroller General of Drugs of India, VG Somani.
Unlike Covishield, the Indian version of the AzstraZeneca vaccine, Covaxin has struggled to gain acceptance among some states and recipients.
In authorizing Covaxin, the drug regulator specified that the vaccine was in “clinical trial mode,” requiring everyone who received the injection to sign an informed consent and was supposed to be more actively monitored.
Additionally, the regulator ordered Bharat Biotech to submit its vaccine safety data much more frequently than the 15-day frequency requested from the Serum Institute for Covishield.
Also, since it was in clinical trial mode, Bharat Biotech, unlike the Serum Institute, was supposed to pay compensation for any vaccine-related injuries. This may not be necessary when the condition is removed.
Government regulations allow compensation during clinical trials, but there is no such provision for hits that have received an emergency license.
Mint was unable to determine whether the SEC established any conditions for Bharat Biotech for the ‘clinical trial mode’ status to be removed.
A spokesperson for Bharat Biotech was not immediately available for comment.
The announcement of the interim efficacy data has already helped increase acceptance: Chhattisgarh Health Minister TS Singh Deo has said he will allow its use if the DCGI grants full authorization.
An authorization without the ‘clinical trial’ label will be significant, considering that Covishield was approximately 53% effective for the current regimen of two full doses administered four weeks apart, and an average of 62% for intervals ranging between four and 12 weeks. .
The most burdensome condition for authorization was because the vaccine had no efficacy data, unlike Covishield, which had efficacy data from the AstraZeneca Plc and Oxford University trials, as well as an emergency use authorization from the UK.
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