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Wednesday, April 14, 2021

Covaxin off clinical trial mode, to have same authorisation as SII’s Covishield

The development, which follows recommendations of an expert panel under the regulator, means Covaxin will now have the same authorisation as Serum Institute of India’s Covishield.

Written by Prabha Raghavan | New Delhi |
March 12, 2021 3:57:06 am
Health workers collect swabs for Covid-19 testing in Thane, Maharashtra. (Express Photo: Deepak Joshi)

The country’s top drug regulatory body on Thursday revised its permission to Bharat Biotech for use of Covaxin, taking the Covid-19 vaccine out of “clinical trial mode” in the ongoing immunisation programme.

The development, which follows recommendations of an expert panel under the regulator, means Covaxin will now have the same authorisation as Serum Institute of India’s Covishield.

On Thursday, Drugs Controller General of India (DCGI) Dr V G Somani amended the authorisation initially granted to Bharat Biotech for “restricted use in emergency situation in public interest,” a senior government official told The Indian Express. In doing so, he omitted the condition imposed on January 3 that the vaccine be administered “in clinical trial mode”.

However, keeping in line with recommendations of a subject expert committee on the matter, the DCGI has mandated that Bharat Biotech continue its ongoing late-stage human trials of the vaccine. The company had recruited around 25,800 participants in this trial, of which half were given Covaxin and the rest were administered a placebo.“The phase 3 (trial) will have to continue. Long-term follow up of the safety remains,” the official cited above said.

Following Bharat Biotech’s announcement on March 3 that Covaxin had an interim efficacy of 80.6 per cent, the SEC on Wednesday decided to back the company’s request that the vaccine be taken out of clinical trial mode.

The efficacy of Covaxin is a marker of its ability to bring down symptomatic cases of Covid-19 in those vaccinated, as opposed to those who did not receive a vaccine. Health experts expect the latest development to shore up confidence in Covaxin’s safety and lead to an increase in its uptake.

“A lot of people have had doubts because they were not expecting to be part of a study when they came to get vaccinated. I think having a message now that says, based on interim efficacy data, the regulator has cleared this vaccine and no longer requires the ‘clinical trial mode’ would be very helpful in enhancing uptake,” said Dr Gagandeep Kang, vice-chair of CEPI and professor at
Christian Medical College-Vellore.

“For the future, possibly this means that when the vaccine is licensed and used by the government, the company will not be liable for serious adverse events, because the way it usually works is that, when you are given a vaccine after it is licensed, and in the national immunization programme, then the burden is not on the company but on the provider of the vaccine,” she said.

At the same time, she said that at the moment it is unclear as to who would really be liable in case a serious adverse event was found, particularly since Covaxin and Covishield are not as yet licensed.

“COVAX has asked every country…to ensure that there is no liability for the company supplying vaccines even under emergency use authorisation,” Dr Kang said. “India has gone in the direction of saying that, if there’s a problem and it’s because of a vaccine made by an Indian company, even if the vaccine is provided by the government it’s essentially not (government’s) liability.”

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