Covaxin granted restricted EUA

Bharat Biotech’s indigenously developed Covaxin is out of the “clinical trial mode” and 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.

“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.

The Subject Expert Panel on COVID-19 of the 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”.