Despite the fact that Bharat Biotech’s North American partner has been requesting emergency use permission from Health Canada for more than six months, the agency has stated that the evaluation is still “ongoing” and that it is impossible to estimate when a decision will be made.
Vaccigen, the Canadian subsidiary of Bharat Biotech’s partner, the American company Ocugen, submitted Covaxin in Canada on June 30, 2021.
However, it is unclear when and if the Covid-19 vaccine will be approved for use in Canada by authorities. “A decision will be made once all of the required information has been thoroughly evaluated by Health Canada,” the department stated in a tweet on Thursday. It’s impossible to say when a regulatory decision will be made because the review is still continuing.”
According to Health Canada, it conducts an impartial examination of vaccination applications and approves products based on “scientific rigor and medical evidence.”
“The timing of Health Canada’s review is dependent on a number of factors, including the need for additional data, discussions with the sponsor, and requirements for safety information updates,” it said.
The World Health Organization (WHO) authorized Covaxin for emergency use in November 2021. It is recognized in Canada for travel purposes, since the nation began recognizing persons who have received two doses of Covaxin as completely vaccinated on November 30.
Only two vaccinations, those made by Pfizer and Moderna, are now available for administration in Canada, and these two have accounted for roughly 66 million of the total 72 million inoculations administered thus far, including boosters.
Other licensed vaccines, such as those from AstraZeneca and its Covishield version developed by the Serum Institute of India, and those from Johnson & Johnson, have seen little use.
Meanwhile, Health Canada said it was considering an application from Pfizer for a Covid-19 antiviral therapy that was submitted last month “on a priority basis.”
According to the Canadian Press, Health Canada’s top medical adviser, Dr. Supriya Sharma, stated that the drug’s authorization decision will be made within 10 days.