Covid-19 vaccine India update: CDSCO expert panel recommends Covaxin be moved out of ‘clinical trial mode’

By: |
March 10, 2021 9:51 PM

The recommendations have been sent to the Drugs Controller General of India (DCGI) for consideration. If the vaccine is taken off clinical trial mode then the beneficiaries will no longer have to sign a consent form for taking the jab.

CovaxinThe Hyderabad-based Bharat Biotech recently had approached the drug regulator for it to consider removing the 'clinical trial mode' condition.

An expert panel of India’s central drugs authority on Wednesday 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’, official sources said.

The recommendations have been sent to the Drugs Controller General of India (DCGI) for consideration. If the vaccine is taken off clinical trial mode then the beneficiaries will no longer have to sign a consent form for taking the jab.

The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) went through the interim data of Covaxin’s phase-3 clinical trial which showed that the vaccine has an efficacy of 80.6 per cent. Following this, the recommendations were made.

The Hyderabad-based Bharat Biotech recently had approached the drug regulator for it to consider removing the ‘clinical trial mode’ condition.

“The SEC reviewed the interim phase-three trial data of Covaxin on Wednesday after which it recommended emergency use authorisation to the vaccine while removing the condition of it being required to be administered under clinical trial mode,” the source said.

India’s drug regulator had on January 3 granted permission for the restricted use of Covaxin in emergency situation in the public interest as an abundant precaution, in clinical trial mode, especially in case of infection by mutant strains.

“The vaccine (Covaxin) which has been given emergency use authorisation under clinical trial mode is accompanied by three documents. One is the factsheet which is read out and explained to beneficiaries, second is a consent form… and the third an adverse event reporting form where the recipient has to report adverse events for the first seven days,” an official had said earlier.

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