Hyderabad: Bharat Biotech’s partner Ocugen, in its financial results statement for the second quarter of 2021, said it has completed the regulatory submission for Covaxin to Health Canada and the review process is initiated.
“Our regulatory submission to Health Canada and our ongoing discussions with the US Food and Drug Administration continue to provide us direction in potentially obtaining regulatory approvals for Covaxin in North America,” said Dr Shankar Musunuri, chairman, Ocugen.
Ocugen said Bharat Biotech completed and posted its phase 3 clinical trial results for Covaxin demonstrating 77.8 per cent efficacy against overall Covid-19 disease, 93.4 per cent efficacy against severe Covid-19 disease, 63.6 per cent efficacy against asymptomatic Covid-19 disease, and 65.2 per cent efficacy against the Delta variant.
Adverse events in the Covaxin and control arms of the phase 3 clinical trial were observed in 12.4 per cent of subjects, with less than 0.5 per cent of subjects experiencing serious adverse side effects. This data was submitted to a peer-reviewed journal for future potential publication.
In June, an amendment to the agreement with Bharat Biotech was finalised which expanded the company’s rights to develop, manufacture, and commercialise Covaxin into Canada (in addition to the United States).
Soon after in July, the company announced the completion of its regulatory submission to Health Canada for Covaxin, which was accepted under the Minister of Health’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19 and transitioned to a New Drug Submission for Covid-19. The submission was conducted through the Company’s new affiliate, Vaccigen, and the review process has begun in Canada.
Discussions with the US Food and Drug Administration are ongoing, and the company is still proceeding with a strategy focused on the agency’s requested Biologics License Application pathway and determining what data requirements and US-based clinical trials will be required to support such submission.
Technology transfer activities are ongoing between Bharat Biotech and Jubilant HollisterStier, which the company has selected to be its contract manufacturing partner with respect to Covaxin.
Research and development expenses for the three months ended June 30, 2021 included a $15 million up-front payment to Bharat Biotech for the right and license to Covaxin development, manufacturing, and commercialisation in Canada.
Now you can get handpicked stories from Telangana Today on Telegram everyday. Click the link to subscribe.