Covaxin Out Of Clinical Trial Mode, Granted Restricted Emergency Use Authorisation
The Centre said Bharat Biotech International Ltd.'s indigenously developed Covaxin is out of the "clinical trial mode" and that it has now been granted the regular restricted emergency use authorisation just like Covishield manufactured by Serum Institute of India Ltd.
Addressing a weekly press conference, NITI Aayog member (Health) Dr. VK Paul said Covaxin and Covishield 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. 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.Dr. VK Paul, Member - Health, NITI Aayog
"It is the triumph for India's research and development enterprise and science and technology enterprise," he added.
India's drug regulator on Jan. 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.