Covaxin completes clinical trials, approved for restricted emergency usage authorization

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The Union Government on Thursday declared Covaxin, developed by Hyderabad-based Bharat Biotech has completed the clinical trials and has been granted with the emergency use authorization with restriction, like approvals for Covoshield which is manufactured by Serum Institute of India.

During a press conference, Dr V K Paul, NITI Aayog Member (Health) revealed that from now on Covaxin and Covishield will have the same licensure.

Paul said, “The condition of it (Covaxin) being required to be administered under clinical trial mode is no more there.”

He further added, “Both the Covid-19 vaccines Covaxin and Covishield have the same licensure status. It has already being given to around 19 lakh people. Covaxin has stood the test of time in terms of great safety. Only 311 individuals had minimal side effects. It is the triumph for India’s research and development enterprise and science and technology enterprise.”

On January 3, India’s drug regulator had granted permit for restricted utilization of Covaxin for emergency situations in the public interest as an abundant precaution, particularly for mutant strains.

The Covid-19 Subject Expert Panel of CDSCO had given the recommendation for giving emergency use authorization and should be excused from the conditions parallel to “clinical trial mode”.

The Drugs Controller General of India (DCGI) said to Bharat Biotech, “”Accordingly, based on the recommendations of the SEC, the condition, ‘this permission is for restricted use in emergency situation in public interest as an abundant precaution in clinical trial mode’ in the permission is amended to read as this permission is for restricted use in emergency situation in public interest.”

It said, “However, you are required to continue ongoing phase-3 clinical trial as per approved clinical trial protocol and submit revised summary of product characteristics, prescribing information and fact sheet.”

Regarding the phase – 3 vaccination drive timeline and the related beneficiaries, Paul said, “We are now focused on the relatively large group of individuals above the age of 60 as well as those aged 45- 60 with comorbidities. We are building a momentum to cover this significantly large group.”

Paul said, “We will see progress and moving forward, yes, further increase in the circle of those who are eligible will be considered.”

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