Health Canada sticks with Evusheld despite U.S. FDA dropping the COVID drug

While Health Canada says it is "aware" of the U.S. decision to withdraw the emergency use of Evusheld, a drug by AstraZeneca used to help prevent COVID-19 infection--- the agency is maintaining its approval, citing the differences in variant circulation between Canada and the U.S.

The U.S. Food and Drug Administration (FDA) announced on Jan. 26 that its emergency use authorization of the drug was pulled due to its inefficacy in treating “certain” COVID-19 variants.

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The FDA stated in a release on its website that as the XBB.1.5. variant, nicknamed “Kraken”, is making up the majority of cases in the country, the use of Evusheld is “not expected to provide protection” and therefore not worth exposing the public to possible side effects of the drug, like allergic reactions.

In an email to CTVNews.ca, Health Canada said the U.S. Food and Drug Administration pulled the drug as the main variant of concern in the U.S. is XBB.1.5.

"Dominant variants in the [U.S.] may be different from those circulating in Canada," the federal agency said in an email. "The most recent epidemiological data in Canada (as of January 1, 2023) indicate that BA.5 (Omicron) subvariants continue to account for more than 89 per cent of reported cases."

On Jan. 6 the FDA said in press release that certain variants are not neutralized by Evusheld and cautioned people who are exposed to XBB.1.5. On Jan. 26, the FDA then updated its website by saying it would be limiting the use of Evusheld.

"Evusheld is not currently authorized for use in the U.S. until further notice by the Agency," the FDA website states.

On Jan. 17, Health Canada issued a "risk communication" on Evusheld, explaining how it may not be effective against certain Omicron subvariants when used as a preventative measure or treatment for COVID-19.

"Decisions regarding the use of EVUSHELD should take into consideration what is known about the characteristics of the circulating COVID-19 variants, including geographical prevalence and individual exposure," Health Canada said in an email.

Health Canada says Evusheld does neutralize against Omicron subvariant BA.2, which according to the agency, is the dominant variant in many communities in Canada.

The drug was introduced for prevention measures specifically for people who have weaker immune systems and are unlikely to be protected by a COVID-19 vaccine. It can only be given to people 12 years and older.

"EVUSHELD is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended," the agency's website reads.

Health Canada says no drug, including Evusheld, is a substitute for vaccination.