Covid-19: Ocugen says Covaxin under 'active review' in Canada
In July, Bharat Biotech's partner for US and Canada markets completed submission of papers for emergency use authorisation of the vaccine in Canada.
Ocugen, Bharat Biotech’s partner for the US and Canadian markets, has said that the Hyderabad-based firm’s anti-Covid shot, Covaxin, is under “active review” of Canadian health authorities. The application for vaccine's emergency use authorisation (EUA) in Canada was made on June 30, while the process of data submission and documentation was done between July 15 and 20.
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“We have submitted everything that was needed for submission in Canada. All I can say is that the vaccine is under active review of Health Canada. On the specific timeline and approval clock, we can’t give you that at this stage,” Shankar Musunuri, chairman and chief executive officer of Ocugen, was quoted as saying on Friday.
On July 30, both Health Canada and Public Health Agency of Canada informed that the review was “under way.”
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In June, the United States Food and Drug Administration (USFDA) rejected Covaxin’s EUA application, and sought more data on clinical trials of the vaccine. Afterwards, Ocugen announced it would only apply for full approval for the shot in the US market.
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Bharat Biotech announced final phase 3 trial results for Covaxin in July, claiming that it was found to be 77.8% effective against mild and moderate Covid-19 cases. The corresponding figures for asymptomatic Covid-19 cases, severe cases and against Delta variant were 63%, 93% and 65%, the company noted in a statement.
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Covaxin is among five Covid-19 vaccines which have received approval in India, but is the only indigenous shot to have been approved thus far. The other four are Covishield, Sputnik V and the respective vaccine candidates of Moderna and Johnson & Johnson. The J&J shot is the latest to have been cleared for use in the country.
(With PTI inputs)
