Bharat Biotech’s Covaxin has shown 77.8 per cent efficacy in Phase III trials, according to sources in the Government’s panel of experts which has reviewed the phase 3 clinical trial data of the country’s indigenous Covid-19 jab. The phase 3 data will now be reviewed by the top drug regulator, Directorate of Controller General of India (DCGI).
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 many developed countries like the UK and the US.
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 (EUA) by the Drugs Controller General of India (DCGI) in January 2021, and has been used to vaccinate the population since. However, the WHO is yet to give it EUA approval, restricting its export to many developed countries like the US and the UK.
“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 on the condition of anonymity said. “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, the sources said.
A panel of independent experts, SECI advises the DCGI on applications seeking approvals for new drugs, vaccines and clinical trials. Hyderabad-based Bharat Biotech 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.
Besides Covaxin, Covishield, developed by AstraZeneca and manufactured locally by Serum Institute of India and Russia’s Sputnik V are the other two vaccines being currently used in India.