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Updated August 7th, 2021 at 16:12 IST

Covaxin data is under review by Canada's health regulator, says partner Ocugen

Biotech company Ocugen currently holds an agreement to produce Covaxin in Canada in addition to the existing rights in the United States.

Reported by: Vishnu V V
Covaxin
IMAGE: PTI | Image:self
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In a positive development for Bharat Biotech, Ocugen, the biotech company which is the US and Canada partner for Covaxin, has said that the vaccine’s data is currently under review by the Canadian health regulator. The company has now informed that all data of the vaccine has been submitted to the Canadian government. Ocugen had joined in on an agreement with Bharat Biotech to develop, manufacture, and commercialize the COVID-19 vaccine, in June.

Covaxin under review of Canadian health regulator

Ocugen currently holds an agreement to produce Covaxin in Canada in addition to the existing rights in the United States. The company has now approached Health Canada and submitted the Phase 3 clinical trial data of Covaxin. The company looks to get authorization from the government to sell the vaccine in the country.

Addressing the development, Shankar Musunuri, Chairman and Chief Executive Officer of Ocugen said that there is an ‘approval clock’ in work in terms of the vaccine. "We have submitted all the data, what is needed for the submission. And again, on the specific timeline and the approval clock, we can't give you that at this stage. 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," the CEO said on Friday.

Ocugen backs Bharat Biotech's vaccine production

Explaining the availability of the vaccine, Shankar Musunuri said that Bharat Biotech is capable of supplying the required quantities of Covaxin to the USA and Canada. The Ocugen CEO said that the Indian vaccine maker is ramping up production and is aiming to manufacture half a billion doses annually. Meanwhile, Ocugen in a release confirmed that discussions with the US Food and Drug Administration (FDA) are also underway.

However, the FDA had earlier potentially delayed the launch of the Covaxin jab in the US market, after it "recommended" Ocugen to go for Biologics License Application (BLA) route. The company was asked to take the long route with additional data. "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 had said.

IMAGE: PTI

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Published August 7th, 2021 at 16:12 IST

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