Covaxin will no longer carry out clinical trial mode label

New Delhi, Mar 12: Covaxin by Bharat Biotech will no longer have to carry out the clinical trial mode label. Covaxin was earlier granted restricted emergency use authorisation before the trials were complete.

NITI Aayog member, Dr. V K Paul said that Covaxin has been granted permission for restricted use in an emergency situation in the interest of the public.

"Covaxin has now been given to more than 19 lakh people and there have been only 311 cases of side-effects. Covaxin has stood the test of time," Dr. Paul said.

"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.

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".

Replying to a question 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 a 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.