Hyderabad: Ocugen, the US and Canada partner of Bharat Biotech for Covaxin, has said it has submitted all data to the Canadian government and it is under active review of the health regulator there.
In June, Ocugen entered into an agreement with Bharat Biotech to develop, manufacture and commercialise the Covid-19 vaccine, Covaxin in Canada in addition to the existing rights in the United States.
However, on June 10, the US Food and Drug Administration (FDA) refused an emergency use authorization (EUA) to Covaxin on the basis of inadequate data from clinical trials. Bharat Biotech’s US partner Ocugen, stated they have decided to pursue a biologics license application (BLA) for its Covid-19 vaccine candidate, Covaxin.
Later the Bharat Biotech attended meeting for World Health Organisation’s Emergency Use Listing on June 17. There, the company said, that it had submitted 90 per cent of the documentation needed for WHO’s EUL.
Ocugen later approached Health Canada and submitted the Phase 3 clinical trial data of Covaxin seeking authorization to sell the jab in that country.
“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 on Friday in an Earnings call.
“All I can say is it’s under active review by Health Canada. As we get questions, we’re ready to respond to them very promptly and provide any information they need,” he said.
Replying to a query he said 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.
In a move that could potentially delay the launch of Covaxin in the US market, the FDA had earlier “recommended” Ocugen, to go for Biologics LicenseApplication (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.
(With inputs from PTI)