Canada on Thursday approved British drugmaker AstraZeneca's drug for the prevention of COVID-19 in immune compromised adults and children.
In a statement, Health Canada said the department has determined that the drug named "Evusheld" meets Health Canada's stringent safety, efficacy and quality requirements.
The drug was 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, the statement said.
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, Health Canada said, adding that no drug, including Evusheld, is a substitute for vaccination.
"Vaccination remains the most important tool in preventing serious illness from COVID-19 infection," Heath Canada said.
According to the statement, 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.