Question Period Note: THERAPEUTIC PRODUCTS PROCURED TO TREAT COVID-19

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• The Government of Canada is taking steps so that safe and effective COVID-19 treatments are available to everyone in Canada who needs them, which along with vaccines and public health measures, save lives, reduce illness and alleviate the burden on health systems.
• The Government of Canada is taking steps so that everyone in Canada who needs them has access to safe and effective COVID-19 treatments. Together with vaccines and public health measures, these treatments save lives, reduce suffering and alleviate the burden on health systems.
• Access to effective treatments that can be easily taken at home, such as PAXLOVID™, could be critical to reducing the severity of COVID-19 in people at risk of severe outcomes from infection.
• These treatments are needed to keep people out of hospitals, shorten hospital stays, and prevent hospitalized patients from progressing into critical care.
• Ten COVID-19 therapeutic treatments have been purchased, distributed, and administered to patients across the country.
• The Government of Canada continues to monitor the emerging science for potentially promising therapeutics to combat COVID-19.

If pressed - PAXLOVIDTM
• PAXLOVID™ is an antiviral pill to treat mild to moderate COVID-19 in adults who are at high risk of progressing to serious illness. PAXLOVID is the first Health Canada-approved COVID-19 drug that can be taken by patients at home.
• The Government of Canada signed an agreement with Pfizer to procure 1.5 million treatment courses of PAXLOVID™ in 2022.
• To date, over 700,000 treatment courses of PAXLOVID™ have been distributed to provinces and territories, with the remaining supply to follow through the fall.

If pressed - Evusheld
• Healthcare professionals are advised to consider local epidemiology and individual exposure to circulating SARS-CoV-2 viral variants when making decisions regarding the use of Evusheld™.

If pressed
• Agency officials are working with colleagues at Health Canada and Public Services and Procurement Canada, and with provinces and territories, to get these therapeutics into the hands of healthcare providers as quickly as possible.
• Information about costs and pricing cannot be released publicly due to commercial confidentiality concerns; however, the Government has identified over two billion dollars for the purchase of COVID-19-related treatments.

In response to the public health crisis arising from the COVID-19 pandemic, the Public Health Agency of Canada (PHAC) was tasked with procuring therapeutics for the treatment of COVID-19 patients on behalf of provinces and territories.

In July 2020, Health Canada authorized the antiviral remdesivir as the first drug for the treatment of COVID-19 in hospitalized patients, and the first shipment arrived in September 2020.

Remdesivir continues to be available to provinces and territories and has recently been authorized by Health Canada for the treatment of mild to moderate COVID-19 in an outpatient setting. When administered within 7 days of symptoms appearing, remdesivir was demonstrated to reduce the need to hospitalize patients who are at high risk of developing severe COVID-19.

Canada is also procuring monoclonal antibodies (mAbs) to treat COVID-19. Monoclonal antibodies are a type of protein that attaches to the spike protein of the coronavirus (SARS-CoV-2) that causes COVID-19 and prevents the virus from entering and infecting healthy cells within the body.

Health Canada has authorized several mAb treatments. These drugs may be used for the treatment of mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19, including hospitalization or death.

Canada is also continuing to procure therapeutics to treat patients with severe COVID-19, such as tocilizumab and sarilumab.

Health Canada authorized the combination of two antiviral drugs, nirmatrelvir and ritonavir (brand name PAXLOVIDTM) on January 17, 2022. The first shipment of PAXLOVIDTM was received and distributed in January 2022, with additional shipments continuing throughout the year. PHAC has procured 1.5 million treatment courses for delivery during the 2022 calendar year.

This antiviral treatment is in pill form, taken orally, under prescription from a healthcare provider. This is an important step forward in ensuring timely access to COVID-19 treatments and reducing the burden on health care systems.

PAXLOVID™ is intended for use as soon as possible after a diagnosis of COVID-19; within five days of the start of symptoms.

Canada has also procured Evusheld™ (tixagevimab co-packaged with cilgavimab), by AstraZeneca, used for pre-exposure prophylaxis for the prevention of COVID-19.

Health Canada authorized Evusheld™ for use in immunocompromised individuals who may not have an adequate immune response to an authorized COVID-19 vaccine, and for those for whom vaccination is not recommended due to approved medical reasons.

Evusheld™ is Canada’s first non-vaccine drug authorized for the prevention of COVID-19. However, it is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.

AstraZeneca submitted an application to Health Canada for authorization for Evusheld™ to be used as a treatment for COVID-19. The authorization was granted on October 18, 2022.

On October 26, 2022, Health Canada issued a health professional risk communication stating Evusheld™ may not be effective against certain SARS-CoV-2 Omicron sub-variants when used as a prophylaxis or treatment for COVID-19.

The Government of Canada has also signed an advance purchase agreement with Merck to procure an initial quantity of 500,000 treatment courses of their oral antiviral, molnupiravir, if it is authorized by Health Canada.

Health Canada is monitoring the safety and effectiveness of authorized treatments as they are in use, as well as requesting manufacturers to submit evidence on the efficacy of those under review against variants of concern, including Omicron and its sub-variants.

Health Canada will take prompt action if new data suggest that the benefit-risk profile of the authorized treatments is affected by variants of concern, and to protect the health and safety of Canadians.

• The Public Health Agency of Canada (PHAC), with the support of Public Services and Procurement Canada (PSPC), is continuing to secure safe and effective therapeutics to treat COVID-19.
• Guided by the needs and concerns of provinces and territories, we have selected products approved by Health Canada and allocated them to the jurisdictions on the basis of need and equity.
• Over 2.6 million treatment courses of ten different COVID-19 therapeutics have been made available to provincial and territorial health systems, so people across Canada who need them have access to safe and effective treatments in both inpatient and outpatient settings.
• PHAC’s therapeutics procurement strategy is evolving. As some products are found to be less effective against new variants of concern, the approach is to shift away from them and towards more effective ones, in accordance with the expressed needs of provinces and territories.
• PHAC continues to monitor emerging therapeutics research to identify promising treatments for the future. All therapeutics must be authorized by Health Canada before they can be procured for use in Canada.
• PHAC is also taking steps to study patient outcomes during and after treatment. We are working in close collaboration with provinces and territories to learn from their experiences.