Bharat Biotech Covid-19 vaccine, Covaxin, is under active review of the Canadian health regulator, Ocugen, the US and Canada partner of Bharat Biotech said on Saturday.
This year, in June, Ocugen entered into an agreement with Bharat Biotech to develop, manufacture and commercialise the Covaxin in Canada in addition to the existing rights in the US.
Ocugen has submitted the Phase 3 clinical trial data of Covaxin seeking authorisation to sell the Covid-19 vaccine in Canada.
“We have submitted all the data, what is needed for the submission — for Canadian submission. And again, on the specific timeline and the approval clock, we can’t give you that at this stage,” Shankar Musunuri–Chairman and Chief Executive Officer of Ocugen said. “All I can say is it’s under active review by Health Canada,” he added.
Further, the Ocugen chairman said that Bharat Biotech is capable of supplying required quantities of Covaxin to USA and Canada as the Indian vaccine maker is ramping up production, targeting to produce more than half a billion doses per year.
Ocugen in a release said discussions with the US Food and Drug Administration (US FDA) are underway, and the company is still proceeding with a strategy focused on the agency’s requested Biologics License Application pathway.
The FDA had earlier “recommended” Ocugen, to go for Biologics License Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation for the jab.
“We have most of the data from Phase III clinical trial, including all the manufacturing. We are still discussing the regulatory path for the BLA, what is required, if any, additional studies,” Musunuri said.
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