CDSCO drops 'clinical trial mode' for Covaxin easing restrictions for its use

The Central Drugs Standard Control Organisation (CDSCO) on 11 March changed the status of Bharat Biotech’s COVID-19 vaccine Covaxin and dropped the “clinical trial mode” label attached to the vaccine.

By Newsmeter Network  Published on  11 March 2021 2:52 PM GMT
CDSCO drops clinical trial mode for Covaxin easing restrictions for its use

Hyderabad: The Central Drugs Standard Control Organisation (CDSCO) on 11 March changed the status of Bharat Biotech's COVID-19 vaccine Covaxin and dropped the "clinical trial mode" label attached to the vaccine. This eases restriction and beneficiaries receiving the vaccine will no longer have to sign a consent form to take Covaxin.

In clinical trial mode, people needed to sign a consent form to take Covaxin, one of the two vaccines allowed for use in India, the other being Oxford-AstraZeneca's Covishield, developed by the Serum Institute of India.

An expert committee reviewed the safety and efficacy data of Phase III clinical trials of Covaxin. "After detailed deliberation, the committee recommended for omission of the condition of the use of the vaccine in clinical trial mode. However, the vaccine should be continued to be used under restricted use in emergency situation conditions," said CDSCO.

CDSCO also said that ongoing Phase III clinical trials should be continued as per the approved protocol. The firm should update the prescribing information and factsheet accordingly (under restricted use in emergency situation conditions), it said.

Covaxin is 81 per cent effective in preventing COVID-19 and can work against the UK variant of the virus, Bharat Biotech said on 4 March, after it announced a "first interim analysis" of Phase III trial results.

Its 81 per cent success or efficacy rate was based on this: the trial had a little over 25,000 people. Among this sample, 43 people contracted COVID-19, of them 36 had been given a placebo and seven had been given Covaxin.


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