Health Canada has approved the drug – Evusheld – for use in people 12 years of age and older who are immunosuppressed and unlikely to have an adequate immune response to the COVID-19 vaccine or for whom the COVID-19 vaccine is not recommended. While the vaccines are based on an intact immune system to grow targeted antibodies and cells that fight infections, Evusheld contains the laboratory antibodies tixagevimab and cilgavimab, which are designed to stay in the body for months to reduce the risk of infection. A healthcare professional will give each antibody by injection, usually to the buttocks. Side effects for up to one in 10 recipients are said to include rash, pain or itching at the injection site, with a much smaller number of people experiencing headaches, chills or pain after receiving the vaccine. CLOCKS Immunosuppressed Canadians Concerned About Wider Opening in the Spring:

Loose restrictions on COVID-19 are a concern for some immunosuppressed

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Health Canada said in a statement Thursday that there is not yet enough data to make sure Evusheld is safe for use in pregnant or breastfeeding women, so they are advised to discuss the potential benefits and risks with a healthcare professional. The treatment has already been approved in the United States and its use has been suggested by the European Medicines Agency. Citing studies from Israel and the United States, AstraZeneca said in a statement on Thursday that immunocompromised individuals could be at risk for hospitalization for unprecedented COVID infections. “The key to ending the COVID-19 pandemic is to protect as many people as possible from infection, including those who may need an extra level of protection to prevent COVID-19 from being offered by vaccines alone. We welcome “Today’s approval is an important step in this journey,” said Kiersten Combs, President of AstraZeneca Canada. It is estimated that 14 percent of Canadians aged 15 and over have a weakened immune system that increases the risk of COVID-19 adverse outcomes, according to a 2020 study by Statistics Canada.

Protection against BA.2, says Health Canada

Evusheld was tested against Omicron subtypes BA.1, BA.1.1 and BA.2 in a recent study from the University of Washington in the USA, a study that was not evaluated by peers. The study data showed that the treatment reduced the amount of virus detected in the samples, the viral load, of all Omicron subtypes tested in mouse lungs, AstraZeneca said. The study also showed that it reduces inflammation in the lungs, a critical symptom in severe COVID-19 infections. “Evusheld is expected to maintain its neutralizing activity against Omicron sub-variant BA.2, which is now the dominant variant in many communities in Canada,” Health Canada said in a statement on Thursday. In humans, Evusheld was found to reduce the risk of developing symptomatic COVID-19 by 77% in tests performed largely before the Omicron hit, the British Drug Regulatory Authority said last month. The protection lasted at least six months after a single dose, according to the British Drugs and Drug Administration (MHRA). The MHRA said the treatment should not be given to people who are infected with the SARS-CoV-2 virus that causes COVID, or to people who have recently been exposed to someone with the virus. The properties of Omicron have been shown to avoid the protection of the vaccine to a greater extent than previous variants, as well as to attenuate certain monoclonal antibody therapies used in some patients, such as casirivimab / imdevimab and sotrovimab. AstraZeneca announced in February that it had reached an agreement with the federal government to supply 100,000 doses of Evusheld to be delivered in 2022, pending approval in Canada. AstraZeneca’s collaboration with the University of Oxford led to one of the first approved vaccines for COVID-19. While a rare coagulation problem found in some vaccine recipients has led many Western countries, including Canada, not to focus on its use, the vaccine has been given to less than three million Canadians and 67 million people worldwide, according to Health. Canada and monitoring by Our World in Data, respectively.