Bharat Biotech to release results of Covaxin third phase trial in July

Covaxin manufacturer Bharat Biotech on Wednesday said it would release the results of long-awaited third phase clinical trial of the home-grown vaccine in July as investigators were analysing more than 70 lakh data points.

The phase-3 data will first be submitted to the Central Drugs Standard Control Organisation, followed by publication in a peer-reviewed journal within three months. But as a pre-print, the phase 3 trial data will come out to the public next month, the company said.

The indigenous vaccine is yet to be recognised by the World Health Organization (WHO) in the absence of phase-3 clinical trial data. As a consequence, those travelling abroad are advised to take the Covishield jab to get a Covid-19 vaccination certificate.

While the government is in talks with the WHO for Covaxin’s recognition, absence of the third phase trial data has turned out to be a stumbling block.

Describing the phase-3 evaluation as the “largest efficacy trial conducted in the developing world” with a sample size of 25,800, Raches Ella, who leads the Covid-19 projects at Bharat Biotech, said since the last volunteer received the second dose of the vaccine and there was a mandatory two-month follow up period, the entire data were available for analysis only in mid-May.

Since each participant filled 30 separate forms and there were 25,800 participants, a team of researchers are now analysing 70 lakh data points. The statistical analysis is being carried out by researchers from another company because, being a blinded trial, neither Bharat Biotech nor ICMR has access to the final data set.

“After submitting efficacy and 2-months of safety to the CDSCO in July, it is expected to instantly reach a pre-print server. Peer review would take another 2-4 months,” tweeted Ella.

“Our nine publications on Covaxin are a testament to Bharat Biotech and ICMR's scientific prowess. The efficacy paper will be our tenth. If you are looking for Covid vaccine data generated in India, rest assured you will only find Covaxin,” he said, taking a potshot at Covishield – the AstraZeneca-Oxford University vaccine, which is being manufactured in India by Serum Institute.