While it has been over six months since Bharat Biotech’s North American partner submitted Covaxin for emergency use approval from Health Canada, that agency has said that the review is still “ongoing” and is unable to predict when a decision in this regard will be taken.
Covaxin’s submission in Canada was on June 30, 2021 by Vaccigen, the Canadian subsidiary of Bharat Biotech’s partner, the American company Ocugen.
However, there is no clarity on when, and if, regulators will clear the Covid-19 vaccine for use in Canada. In a tweet on Thursday, the agency said, “A decision will be made once all of the required information has been thoroughly evaluated by Health Canada. As the review is still ongoing, it is not possible to predict when a regulatory decision will be made.”
Health Canada said it reviews vaccine applications through an independent process and authorises products based on “scientific rigour and medical evidence”.
“Timing for the completion of Health Canada’s review depends on many factors, including but not limited to, the need for additional data, discussions with the sponsor, and requirements for updates to safety information,” it added.
Covaxin was approved for emergency use by the World Health Organization (WHO) in November 2021. It is recognised in Canada for travel purposes, as on November 30 the country started accepting those with two doses of Covaxin as fully vaccinated.
At this time, only two vaccines, those manufactured by Pfizer and Moderna are available for administration in Canada, and these two have accounted for the vast majority of jabs given so far, including boosters, accounting for nearly 66 million out of the total 72 million inoculations given so far.
There has been limited use of other approved vaccines, including that from AstraZeneca and its version Covishield manufactured by the Serum Institute of India, and the vaccine from Johnson & Johnson.
Meanwhile, Health Canada also said it was reviewing “on a priority basis” a submission from Pfizer on a Covid-19 antiviral treatment, the submission for which was received last month. The news agency Canadian Press cited Health Canada’s chief medical adviser Dr Supriya Sharma as saying that the authorisation decision for the drug will be taken within ten days.