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Tuesday, April 20, 2021

Clinical trial mode: Restrictive label that Covaxin is set to shed

The “clinical trial mode” label meant Bharat Biotech had to seek informed consent prior to giving Covaxin to those eligible for the government’s vaccination drive.

Written by Prabha Raghavan | New Delhi |
Updated: March 11, 2021 7:45:51 am
Covaxin, Covaxin efficacy, Bharat BiotechA nurse displays a Covaxin vial at a Covid-19 vaccination centre. (Express Photo: Partha Paul)

In a major development for Bharat Biotech, an expert panel on Wednesday recommended the removal of the “clinical trial mode” label attached to the emergency authorisation of its Covid-19 vaccine, Covaxin.

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A “clinical trial mode” approval means the vaccine would be administered to everyone and they would be monitored closely as if they were in a clinical trial. In a regular clinical trial, some of the participants are given a placebo instead of the vaccine.

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Why the label

The reason Covaxin had been given a restricted emergency use authorisation “in clinical trial mode” was because Bharat Biotech had not completed recruitment of participants for phase 3 trials, and thus not been able to submit information regarding the vaccine’s efficacy . The lack of information had led to some health experts questioning the regulator’s decision to give approval to the vaccine without scrutinising enough data on its ability to bring down Covid-19 cases.

The “clinical trial mode” label meant Bharat Biotech had to seek informed consent prior to giving Covaxin to those eligible for the government’s vaccination drive. It also 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 Covishield maker Serum Institute of India, which has had to submit such data every 15 days so far.

This would also mean that people might be compensated if they had serious adverse reactions that were proven to be “causally related to the vaccine”, according to Bharat Biotech’s informed consent form and factsheet. SII’s factsheet does not mention compensation in case of adverse events.


What now

The Subject Expert Committee under the drug regulator CDSCO has decided to back Bharat Biotech’s request to remove the label from its authorisation. Now, it is up to the Drugs Controller General of India to decide whether it wants to approve the company’s request.

The development follows the company’s announcement on March 3, based on interim data from late-stage clinical trials, that Covaxin had an efficacy of 80.6%. The SEC had initially sought this interim data in January.

The implications

If the DGCI accepts the recommendation, the vaccine can be administered with less stringent conditions — without the company needing to take informed consent from recipients, according to regulatory and health experts.

During the initial roll-out of the vaccination programme, some states and healthcare workers had expressed hesitancy at taking Covaxin. Chattisgarh Health Minister T S Singh Deo had publicly said the state would administer the vaccine once it was “out of the clinical trial mode”.

“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.

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