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Covaxin phase 3 trial data showing ‘77.8% efficacy’ reviewed by expert panel. Over to DCGI

Subject Expert Committee, which advises DCGI on approvals for new drugs & vaccines. has not yet discussed changing the status of Covaxin from emergency use to full licensure.

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New Delhi: The Narendra Modi government’s panel of experts has reviewed the phase 3 clinical trial data of India’s indigenous Covid-19 vaccine Covaxin, which showed 77.8 per cent efficacy in the trial, ThePrint has learnt.

The trial was conducted on 25,800 subjects, and the data submitted to the Subject Expert Committee (SEC) showed the vaccine was “well-tolerated”.

Covaxin had received emergency use approval by the Drugs Controller General of India (DCGI) in January 2021, and has been used to vaccinate the population since.

The phase 3 data will now be reviewed by the DCGI, sources said.

“According to the data submitted, Covaxin has shown 77.8 per cent efficacy in the last stage trials conducted on 25,800 subjects. It is almost the same as the interim efficacy,” a member of the SEC, who did not wish to be named, told ThePrint. “The data shows the vaccine was well-tolerated.”

The SEC, however, did not discuss changing the status of the vaccine from emergency use to full licensure, which means regular approval or marketing authorisation of the vaccine under normal circumstances, sources said.

The SEC is a panel of independent experts, which advises the DCGI, the apex drugs regulator in the country, on applications seeking approvals for new drugs, vaccines and clinical trials. Bharat Biotech, the pharmaceutical company that developed Covaxin, had submitted the data to DCGI over the weekend.

In March, Bharat Biotech had announced an interim efficacy of 81 per cent from the trial, where participants received vaccine or placebo in a 1:1 ratio.

The company had then said the clinical trial will continue through to final analysis, to gather more data and to further evaluate the efficacy of Covaxin. The final data is known to be more accurate and reliable.

The data will also be reviewed by the World Health Organization (WHO) on 23 June for approval. Once approved by WHO, India will be able to export Covaxin to other countries.

Also read: In next step to bringing its Covid shot to India, J&J moves to validate manufacturing process

Why Covaxin’s phase 3 data was awaited

The DCGI had granted permission for emergency use of Covaxin in January this year based on its phase 1 and 2 clinical trials that comprised about 680 participants.

The move was questioned by public health experts, bringing greater attention to the phase 3 data.

Furthermore, the data was first promised in June but was later pushed to July, which increased the scrutiny around the vaccine.

At a press conference on 12 June, Dr V.K. Paul, who heads the country’s Covid task force, had said Covaxin’s phase 3 trial data will be published in the next “7-8 days”.

Why is phase 3 data important? 

Under the phase 3 trial, investigators keep track of participants for at least six months after the last vaccine dose.

If and when a participant falls sick, the data of those falling sick among the vaccinated and unvaccinated cohorts helps calculate the efficacy of the vaccine.

The trial also helps highlight possible adverse events of a vaccine.

Favourable phase 3 results that confirm efficacy and side effects lead to vaccines being approved for general human use.

Also read: Fast pace of vaccination is key to opening of economy, says Niti Aayog member VK Paul


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