The Drugs Controller General of India (DGCI), on Thurdsay 11 March, has authorized Bharat Biotech’s Covaxin for emergency use without the ‘clinical trial mode’ tag.
This move comes following a recommendation, on Wednesday, from the Subject Expert Committee (SEC) after they evaluated the prelim phase 3 data submitted by the pharma company.
The authorisation, signed off by Dr V G Somani, the DGCI, states the Vaccine was to remain “for restricted use in emergency situations in the public interest.” Except it will no longer carry the tag of “as an abundant precaution in clinical trial mode.”
On March 3, Bharat Biotech had released the preliminary data that indicated the vaccine has 81 percent efficacy. The data is yet to be peer reviewed.
Speaking of this at a press conference on Thursday, 11 March, Niti Aayog member Dr Vinod Paul called Covaxin’s new status of ‘regular’ emergency authorisation, a “triumph for India’s science and technology enterprise.”
“This has taken the authorisation of Covaxin to the next level, the same level as our other vaccine Covishield.(What this means is that) both vaccines now have the same level of licensure backup.”Dr Vinod Paul, Member, Niti Aayog
Covaxin, along with Covishield, was approved for restricted emergency use on 3 January by the DCGI. Since the phase 3 efficacy data from Covaxin was not in, and the vaccine was still under clinical trials, the permission included several riders, including the term 'clinical trial mode.'
Dr Paul reiterated that while Covaxin was first approved for public use back in January, but the condition to scale it up in the ‘clinical research mode’ was done “in the interest of abundant precaution.” “Now that condition is no longer there. The vaccine has stood the time of great safety,” he adds.
The exact terminology read:
“Grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.”
The vaccine was placed in ‘clinical trial mode’ when it was authorised for public use without having cleared all phases of the clinical trial.
This was done to monitor those who got Covaxin in a sort of ‘open-label’ trial.
What Does 'Clinical Trial Mode' Mean and Why Does This Matter?
Those given Covaxin during phase 1 of vaccination had to sign a form that spelt out what clinical trial mode meant. The form said:
- In phase 1 & 2, the clinical trials COVAXIN has demonstrated the ability to produce antibodies against COVID-19. However, the clinical efficacy of COVAXIN is yet to be established and it is still being studied in phase 3 clinical trial. Hence it is important to appreciate that receiving vaccine does not mean that other precautions related to COVID-19 need not be followed.
- In case of adverse events, or serious adverse events you will be provided medically recognised standard of care in the government designated and authorised centers/hospitals.
- The compensation for serious adverse event will be paid by sponsor (BBIL) if the SAE is proven to be causally related to the vaccine.
As it is no longer in this 'mode', this form will now be dropped.
A clarification that would be needed, however, would be around liability - according to the form, the liability lay with Bharat Biotech
It must be clarified, however, that Covaxin remains in emergency use. What the SEC authorisation means is just that the nomenclature around it will be removed.
The DGCI has also said, that “the ongoing phase III clinical trial should be continued as per the approved protocol.” And that “all other conditions of the marketing authorisation shall continue to remain the same.”
At the time of its approval several healthcare workers had expressed hesitancy towards accepting the vaccine. Several experts had said they would wait for phase 3 efficacy data to decide whether they would take the vaccine. Several states had also said they would not be accepting Covaxin till more data is out.
What Did Covaxin's Phase 3 Prelim Data Find?
On Wednesday, 3 March, Hyderabad-based vaccine manufacturer Bharat Biotech had announced the phase 3 clinical results of their indigenously-made COVID-19 vaccine candidate Covaxin. As per the trial results, Covaxin has an interim clinical efficacy of 81 per cent against COVID-19 in those without prior infection after the second dose.
The data has come from 25,800 trial participants who received a vaccine or placebo in a 1:1 ratio that showed that the vaccine candidate was well-tolerated, said a report by the company. The first interim analysis was based on 43 cases.
FIT spoke with virologist Dr Shahid Jameel to decipher what the data meant:
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