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Bharat Biotech data on 43 Covid cases convinced govt to drop Covaxin from clinical trial mode

Decision to allow Covaxin to exit the clinical trial mode means the vaccine can be administered with less stringent conditions and could result in a higher intake.

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New Delhi: The Modi government’s expert panel agreed to drop the use of Bharat Biotech’s Covid-19 vaccine Covaxin under “clinical trial mode” after the firm presented an “updated” analysis on “43 cases”.

This means the vaccine can be administered with less stringent conditions such as not requiring written consent from recipients.

Hyderabad-based Bharat Biotech, which developed the vaccine, had presented an updated “interim safety and efficacy data of its phase III clinical trial of Whole Virion, Inactivated Corona Virus Vaccine (BBV152) in the country”.

According to the minutes of a 10 March meeting held by the subject expert committee (SEC), the committee noted that the firm had carried out an interim analysis after 43 cases of symptomatic RT-PCR positive cases were reported, of which 36 were in the placebo arm and 7 in the vaccine arm.

The SEC advises the apex regulator Drug Controller General of India (DCGI) on applications seeking approvals for new drugs, vaccines, and clinical trials for Covid-19.

“After detailed deliberation, the committee recommended for omission of the condition of the use of the vaccine in clinical trial mode,” stated the minutes that were uploaded Thursday to the Central Drugs Standard Control Organisation’s (CDSCO) website — the health ministry arm that regulates the quality of drugs and vaccines in the country.

However, the vaccine will continue to be used under restricted use in emergency situation conditions.

The committee also said the ongoing phase 3 clinical trial will be continued according to the approved protocol.

“The firm should update the prescribing information and factsheet accordingly (under restricted use in emergency situation condition),” it said.

The recommendation was approved by DCGI Thursday, which sent a letter confirming the same to Bharat Biotech. ThePrint has accessed this letter.

Also read: Covaxin a ‘buffet’ vaccine that can deal with mutations, others ‘a la carte’ — top virologist

What exit from clinical trial mode means

On 3 January, the DCGI had granted approval to Covaxin “as an abundant precaution”, but on the condition that it be administered in “clinical trial mode”.

The exit from this trial mode means the vaccine can be administered with less stringent conditions, such as waiving the written informed consent which could lead to an increase in the use of vaccine.

Till now, people who received Covaxin were required to sign a three-page consent form and were closely monitored for any serious side effects. This was regarded as the primary reason for vaccine hesitancy in states where Covaxin is available.

Meanwhile, the vaccine Covishield from Serum Institute of India (SII) submitted interim data on the efficacy from global trials of the AstraZeneca-University of Oxford vaccine.

Also read: Covaxin, Covishield not for everyone — manufacturers list who should avoid the Covid vaccines

Data on Covaxin efficacy

According to the study published in medical journal, The Lancet, immune responses induced by Covaxin last for at least up to three months, with the 28-day interval between the two vaccine doses showing more promise than the 14-day interval.

Covaxin has also shown an interim efficacy of 81 per cent in preventing Covid-19 during the phase-3 trial, which was conducted on 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities.

(Edited by Manasa Mohan)

Also read: Everything you need to know about Covaxin, India’s controversial Covid vaccine


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  1. The safety and efficacy of a killed virus vaccine is known from similar vaccines developed on this platform. However, for any new vaccine it is mandatory to pass through Phase 1, 2 & 3 tests and there the trouble arose. If the Govt and regulators were proactive, the Phase 3 tests could have been started by beginning of Oct ’20, giving reference of same safety invoked at the time of clinical mode approval. The dosing could have been completed by end Nov ’20 and preliminary results would have been available by end Jan, no need for clinical mode etc.

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