Health Canada has authorized the emergency use of PAXLOVID, an investigational medicine, for the treatment of mild-to-moderate COVID-19 in adults, with mild to moderate symptoms, who are at high risk of progressing to serious disease, including hospitalization or death.
The active ingredient nirmatrelvir in PAXLOVIDTM works by stopping the virus from replicating.
Until now, authorized medications for COVID-19 have had to be taken in a hospital or healthcare setting. PAXLOVIDTM is the first COVID-19 therapy that can be taken at home. The drug is intended for use as soon as possible after diagnosis of COVID-19 and within five days of the start of symptoms. The treatment consists of two tablets of nirmatrelvir and one tablet of ritonavir taken together by mouth twice per day for five days.
Health Canada received the submission for PAXLOVIDTM from Pfizer on December 1, 2021, and conducted an expedited review. Pfizer submitted the data to Health Canada on a rolling basis throughout the review process, as new information became available to facilitate a decision as quickly as possible. These data included results from clinical trials for PAXLOVIDTM where patients had not been vaccinated and had not previously been infected with COVID-19.
While the benefits of Paxlovid were found to outweigh the risks, it can cause interactions with other medications for some patients. As such, patients should discuss the risks and benefits of treatment with their healthcare provider.
As with all COVID-19 health products, Health Canada will continue to monitor the safety and effectiveness of PAXLOVIDTM once it is on the market. Pfizer will continue to provide additional data, including data on the potential impacts of existing and new variants of concern. If any new concerns are identified, Health Canada will take immediate action and communicate with Canadians.
No drug, including PAXLOVIDTM, is a substitute for vaccination. Vaccination remains the most important tool in preventing serious illness from COVID-19 infection. Both the Public Health Agency of Canada and Health Canada continue to strongly recommend vaccination for all eligible Canadians, including those who are pregnant, may become pregnant or are breast-feeding.
For detailed information on authorized vaccines and treatments in Canada, visit the COVID-19 vaccines and treatments portal. Learn more about authorized Canadian COVID-19 treatments.
For more details on Paxlovid from Pfizer, please click here.
LIVE: Federal health officials expected to discuss approval process for COVID-19 antivirals https://t.co/hNfpSjWPS1
— Health Canada and PHAC (@GovCanHealth) January 17, 2022
(1/5) Health Canada has authorized the first #Covid19 treatment in pill form that can be used at home to help prevent serious disease. https://t.co/GbaFDrnAA2
— Health Canada and PHAC (@GovCanHealth) January 17, 2022
Health Canada has authorized the first #Covid19 treatment in pill form that can be used at home to help prevent serious disease.https://t.co/bH19PQO0xR
— GC Newsroom (@NewsroomGC) January 17, 2022