Bharat Biotech's Covaxin gets authorisation for emergency use: V K Paul

In January, Covaxin was given restricted use authorisation under clinical trial mode with abundant precaution
Bharat Biotech’s Covaxin has been given the regular emergency use authorisation in public interest, putting it on a par with the approval granted to Serum Institute’s Covishield’s, V K Paul, member-health, Niti Aayog told reporters on Thursday.

 

Health Secretary Rajesh Bhushan added that the government has renegotiated the price of vaccines at a much lower level than before, without sharing any further details. “Earlier price was Rs 200 per dose and Rs 210 with taxes. After that, the re-negotiated price is significantly lower than this.”

 

Paul added: “Covaxin is now allowed for restricted use in emergency usage in public interest. The vaccine has stood the test of time in terms of great safety. Covaxin is now in regular emergency use authorisation, the same as Covishield,” Paul told reporters.

 

In January, Covaxin was given restricted use authorisation under clinical trial mode with abundant precaution. With interim data for phase-3 trials showing an efficacy of 81 per cent, Covaxin would not have to be administered in “clinical trial” mode anymore.

 

“It is the triumph for India's research and development enterprise and science and technology enterprise," Paul said.

 

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".

 

So far 1.9 million people in the country have been given Covaxin, of whom 311 showed some side effects.

 

More than 18 million people have received Serum Institutes’s Covishield vaccine, according to data available on the CoWIN portal.



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