Bharat Biotech’s Covaxin may finally lose its ‘clinical trial mode’ tag.
According to several reports, the recommendation comes from the Subject Expert Committee (SEC) after they evaluated the prelim phase 3 data submitted by the pharma company.
On 3 March, Bharat Biotech had released the preliminary data that indicated the vaccine has 81 percent efficacy. The data is yet to be peer reviewed.
The recommendation will now go to the Drugs Controller General of India (DCGI) who is the final regulatory authority.
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.'
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.”
What Does 'Clinical Trial Mode' Mean and Why Does This Matter?
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.
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.
If it is no longer in this 'mode', it could mean, this form will be dropped. More details are, however, awaited.
Another clarification that would be needed 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.
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 percent 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:
(This story was first published in FIT and has been republished with permission.)
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