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Covaxin’s rollout shed its “clinical trial" label on Thursday. In January, the drugs controller general of India (DCGI) had permitted emergency use of the covid-19 vaccine from Bharat Biotech International Ltd in the clinical trial mode.

On Wednesday, a subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) recommended removing this condition. Subsequently, DCGI V.G. Somani, who heads CDSCO, approved the panel’s suggestion.

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Mint explains how the development could affect India’s and the world’s covid-19 vaccination drive.

What is the ‘clinical trial mode’ condition for Covaxin?

The DCGI on 3 January gave emergency licensure for Bharat Biotech’s indigenously developed covid vaccine Covaxin, along with Serum Institute of India’s Covishield. However, unlike Covishield, the license given to Covaxin was in “clinical trial mode" as it did not have efficacy data to support full authorization.

The label meant that informed consent was required from the vaccinee, and their follow-ups after inoculation would be done more actively. Reporting of safety data from the roll-out would also be more frequent as compared to Covishield.

What was the impact of the “clinical trial mode" label on the Covaxin roll-out?

The lack of efficacy data and requirement to sign an informed consent made vaccinees more hesitant to take the vaccine. Some state governments, like Chhattisgarh and Delhi, did not make much use of Covaxin, while some doctors, like those from Delhi’s central government-run Ram Manohar Lohia Hospital, had also initially protested the use of Covaxin and instead sought Covishield. The hesitancy impacted the uptake of Covaxin. Since the vaccination drive started on 16 January, only 1.75 million people have received Covaxin, while Covishield has seen more than 10 times as many takers at over 18 million, data from government’s CoWin dashboard showed.

Why has the ‘clinical trial’ label being removed?

Essentially, due to disclosure of efficacy data on Covaxin. Bharat Biotech last week announced interim results from its ongoing phase 3 Covaxin trial, which showed an efficacy of 80.6% for two doses given four weeks apart. This was much higher than Covishield’s 53% efficacy for two full-doses given four weeks apart, as well as an average of 62% for doses given anywhere between 4-12 weeks apart.

How will the removal of the label affect vaccine roll-out?

Announcement of the efficacy results as well as the DCGI’s authorization could boost uptake of the vaccine. Chhattisgarh health minister T.S. Singh Deo had last week indicated that the state’s government will allow the use of the vaccine in his state if the DCGI gives a full authorization. Greater uptake would mean that procurement would increase, and its higher efficacy compared to Covishield could also result in better protection against the novel coronavirus among the Indian populace. However, a flip side could be that while in “clinical trial mode", participants could claim compensation if they had a serious side-effect causally linked to the vaccine; such a provision will not be allowed after the full emergency licensure is granted. Government norms allow compensation for vaccine-related injuries during clinical trials, but no such provisions are there for post-licensure roll-out.

What is the way from here on?

With efficacy data in hand and authorization from the Indian regulator, Bharat Biotech can now submit an application to the World Health Organization for emergency use listing of Covaxin, which will make it eligible for use in the WHO-led Covax facility. The company’s officials have earlier indicated their interest in participating in the facility, which aims at equitable access to covid-19 vaccines, especially in low- and middle-income countries.

The company has also applied for further studies in Bangladesh and plans to conduct clinical trials in the US through its partner Ocugen. The 25,800-participant phase 3 trial of Covaxin in India is also ongoing, and there is more efficacy data on it that is still expected, while issues like duration of efficacy, among others, will also be known later.

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