Health Canada authorized Evusheld (tixagevimab and cilgavimab) for the prevention of COVID-19. After a thorough and independent scientific review of the evidence, the Department has determined that Evusheld meets Health Canada’s stringent safety, efficacy and quality requirements.
The drug is approved for use in adults and children (12 years of age and older, weighing at least 40 kg) who are not currently infected with COVID-19 and have not had recent known contact with someone infected with COVID-19, and:
- who are immune compromised and unlikely to mount an adequate immune response to COVID‐19 vaccination; or,
- for whom COVID-19 vaccination is not recommended.
Patients should talk to their healthcare provider to determine if Evusheld is appropriate for them. Evusheld is not currently authorized to treat COVID-19 infection, nor is it authorized to prevent infection in people who have been exposed to the virus.
Health Canada has placed terms and conditions on the authorization. For instance, AstraZeneca is required to continue to provide information to Health Canada on the safety and efficacy of Evusheld, including protection against current and emerging variants of concern, as soon as it is available. Based on laboratory studies, Evusheld is expected to retain neutralizing activity against Omicron subvariant BA.2, which is now the dominant variant in many communities in Canada.
No drug, including Evusheld, 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 up-to-date vaccination for all eligible Canadians.
Health Canada is publishing multiple documents, including information for health professionals and patients, along with a high-level summary of the evidence it reviewed to support Evusheld’s authorization.
As with all COVID-19 health products, Health Canada will continue to monitor the safety and effectiveness of Evusheld. If any new concerns are identified, Health Canada will take immediate action and communicate with Canadians.