Health Canada has approved Pfizer’s Paxlovid Covid-19 medication.
On Jan. 16, the agency updated its website to confirm the medication had been approved for the treatment of “mild-to-moderate” Covid symptoms for those 12 years of age or older who are at risk of severe health outcomes. The drug has not yet been approved for children under 12 years old, nor for those whose symptoms are already considered severe or critical.
According to a summary of the decision, the medication was approved based on the results of a “randomized, double-blind, placebo-controlled” study with more than 1,300 participants that found the drug reduced hospitalization or death by 89 per cent compared to a placebo group. Seven per cent of patients in the placebo group were hospitalized or died, while only 0.8 per cent of those administered Paxlovid were hospitalized, and none died.
Despite the approval, Health Canada acknowledges that more information is needed about the safety and efficacy of the drug. However, “additional safety, efficacy and quality evidence, as well as post-market safety monitoring evidence, will be submitted to Health Canada post-authorization,” the summary reads. The main risks are adverse interactions with other medications, which could result in anything from a loss-of-effect to death.
The medication was also approved by the American Food and Drug Administration on Dec. 22 and the UK Medicines and Healthcare products Regulatory Agency on Jan. 3.