Bharat Biotech’s Covaxin allowed to drop ‘clinical trial mode’ label

The enhanced level of clearance means Covaxin can now be administered without the need for informed consent of the recipients, and is expected to boost vaccination figures.

Bharat Biotech’s Covid-19 vaccine, Covaxin, has been granted restricted emergency use authorisation and will no longer have to carry the “clinical trial mode” label.

Serum Institute of India’s Covishield already has this status.

Addressing a weekly press conference on Thursday, NITI Aayog member (Health) Dr V K Paul said Covaxin has been granted the permission for restricted use in emergency situation in public interest.

“The condition of it (Covaxin) being required to be administered under clinical trial mode is no more there. 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,” Paul was quoted by PTI as saying.

The Indian Express had earlier reported that a Subject Expert Committee (SEC) had recommended to the Drugs Controller General of India that Covaxin’s “clinical trial mode” label be dropped.

The “clinical trial mode” label meant that Bharat Biotech had to seek informed consent before administering its vaccine to those eligible for the government’s ongoing vaccination drive. It also meant the company had to submit updates on the safety, immunogenicity and efficacy of the vaccine from its phase 1, 2 and 3 clinical trials more regularly than SII, which has had to submit such data every 15 days so far.

As per Bharat Biotech’s informed consent form and factsheet, the company had stated it would pay compensation for serious adverse events that are “proven to be causally related to the vaccine.” SII’s fact sheet does not mention this compensation.

Now, the vaccine can be administered without the need for this informed consent.

“This will dispel the cloud of uncertainty that loomed over Covaxin’s efficacy and reassure people that the vaccine will confer immunity with a high level of safety. Uptake of this vaccine has already started rising after March 1 and this augmented level of regulatory clearance will give it greater momentum,” said Dr K Srinath Reddy, president, Public Health Foundation of India.

The enhanced level of clearance comes after Bharat Biotech announced on March 3 that based on interim data from late-stage clinical trials, Covaxin had an efficacy of 80.6 per cent — it was able to bring down symptomatic cases of Covid-19 by nearly 81 per cent in those vaccinated as opposed to those who did not receive a vaccine.

At the time of its approval on January 3, Bharat Biotech had not been able to submit any information regarding the efficacy of Covaxin. This had stirred controversy, with many questioning the approval given to the vaccine without scrutinising enough data on its ability to bring down Covid-19 cases.

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