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CDSCO Expert Panel Recommends Covaxin Exit “Clinical Trial Mode” | India News


NEW DELHI: An expert panel from India’s Central Medicines Authority on Wednesday recommended granting an emergency use authorization to Covaxin indigenously developed from Bharat Biotech and removing the condition for the vaccine to be administered in “mode of clinical trial, “said official sources.
The recommendations have been sent to the Comptroller General of Drugs of India (DCGI) for consideration. If the vaccine is withdrawn from clinical trial mode, beneficiaries will no longer have to sign a consent form to receive the vaccine.
The Central Medicines Standard Control Organization (CDSCO) subject matter expert committee (SEC) reviewed interim data from the phase 3 clinical trial of Covaxin that showed the vaccine to be 80.6 percent effective. The recommendations were then made.
Hyderabad-based Bharat Biotech had recently approached the drug regulator to consider removing the ‘clinical trial mode’ condition.
“The SEC reviewed the interim data from the phase three trial of Covaxin on Wednesday, after which it recommended emergency use authorization for the vaccine and removed the condition that it be required to be administered in clinical trial mode.” the source said.
India’s drug regulator had on January 3 granted permission for the restricted use of Covaxin in emergency situations in the public interest as an abundant precaution, in clinical trial mode, especially in case of infection by mutant strains.
“The vaccine (Covaxin) that has been granted authorization for emergency use in clinical trial mode is accompanied by three documents. One is the information sheet that is read and explained to the beneficiaries, the second is a form consent … and the third an adverse event notification form in which the recipient has to report adverse events during the first seven days, “an official had previously said.

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