Covaxin has been moved out of the clinical trial mode
The Government of India (GOI) on Thursday said Bharat Biotech‘s indigenously developed Covaxin has been moved out of the “clinical trial mode” and that it has now been granted the restricted emergency-use authorisation. Addressing a weekly press conference, NITI Aayog member (Health) Dr V K Paul said Covaxin has been granted permission for restricted use in an emergency situation in the public interest and that both COVID-19 vaccines Bharat Biotech’s Covaxin and Covishield manufactured by Serum Institute have the same licensure status now. “The condition of it (Covaxin) being required to be administered under clinical trial mode is no more there,” Paul said.
“Both the COVID-19 vaccines Covaxin and Covishield have the same licensure status. 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,” he said. India’s drug regulator on January 3 had 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.
Bharat Biotech International Limited is an Indian biotechnology company headquartered in Hyderabad, engaged in the drug discovery, drug development, manufacture of vaccines, bio-therapeutics, pharmaceuticals and health care products.
The Subject Expert Panel (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) had recommended granting emergency use authorisation to Bharat Biotech’s indigenously developed Covaxin while removing the condition for the vaccine to be administered in “clinical trial mode”. Replying to a question of whether the government has a timeline in mind for phase 3 vaccination drive and who gets included in that, 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 momentum to cover this significantly large group.”
“We will see progress and moving forward, yes, further increase in the circle of those who are eligible will be considered,” Paul said.
Bharat Biotech International Limited is an Indian biotechnology company headquartered in Hyderabad, engaged in the drug discovery, drug development, manufacture of vaccines, bio-therapeutics, pharmaceuticals and health care products. Dr Krishna Ella is the Chairman & Managing Director of Bharat Biotech International Limited, which he incorporated in 1996. A gold medallist at university, Dr Ella worked as a research faculty at the Medical University of South Carolina, Charleston after earning his PhD from the University of Wisconsin-Madison.
[with PTI inputs]
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