Bharat Biotech to make Covaxin's Phase-3 results data public in July

The NASDAQ-listed Ocugen has rights to commercialise Covaxin in the US.

Bharat Biotech said it will make Covaxin Phase-3 results data public in July.

The company added that once the data from final analysis of Phase III studies are available, Bharat Biotech will apply for full licensure for Covaxin.

Bharat Biotech in April said it was expecting final analysis data by June.

The company said the Phase-3 data will be first submitted to CDSCO, followed by peer reviewed journals, with a timeline of three months for publication.

"The last participant (participant #25,800) received the second dose in Mid March, add two months (based on CDSCO/FDA requirements for 2-months post-dose-2 safety follow-up), and we are in Mid May with sufficient data for quality checks and analysis," Raches Ella, Project Lead - SARS-CoV-2 Vaccine and Head of Business Development at Bharat Biotech.

Bharat Biotech announced in April that its COVID-19 vaccine Covaxin has 78 percent efficacy based on the interim data of 127 symptomatic COVID-19 cases from participants in Phase-3 trials. The company said the vaccine has demonstrated 100 per cent efficacy against severe Covid-19 disease in phase 3 trials.  As part of the Phase-3 study Bharat Biotech has enrolled 25,800 participants between 18-98 years of age. The company is yet to publish the full Phase-3 trial results.

Covaxin, the country’s first indigenous COVID-19 vaccine, was developed with seed strains received from the National Institute of Virology (NIV), using Whole Virion Inactivated Vero Cell derived platform technology.