Canada on Thursday authorized the therapy of the British drug manufacturer AstraZeneca Plc, based on antibodies, to prevent infections with COVID-19, giving itself another weapon against the disease as cases in the country increase.
Health Canada has authorized Evushold for people 12 years of age and older who are immunocompromised and unlikely to have an adequate immune response to COVID-19 vaccination or for whom COVID-19 vaccination is not recommended.
While vaccines rely on an intact immune system to develop target antibodies and cells that fight infections, Evushold contains laboratory-produced antibodies tixagevimab and cilgavimab, which are designed to stay in the body for months to hold the virus in case of infection.
A healthcare professional administers each antibody by injection, usually in the buttocks.
Side effects in up to one in 10 recipients are thought to potentially include a rash, pain or itching at the injection site, with far fewer people potentially experiencing headaches, chills or soreness after receiving injections.
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Health Canada said in a statement on Thursday that there is still not enough data to make sure that Evushold is safe for use in pregnant or breastfeeding women, so these individuals are advised to discuss the potential benefits and risks with a healthcare professional.
The therapy is already approved in the United States and its use is also recommended by the European Medicines Agency.
Citing research from Israel and the United States, AstraZeneca said in a statement Thursday that immunocompromised individuals may be at risk of hospitalization due to sudden COVID infections.
“The key to ending the COVID-19 pandemic is to protect as many people as possible against infection, including those who may need an extra layer of protection to prevent COVID-19 than vaccines alone can provide. We welcome today’s approval as an important step forward on this journey, “said Kirsten Combs, President of AstraZeneca Canada.
Approximately 14% of Canadians aged 15 or over have a compromised immune system, which increases the risk of adverse outcomes of COVID-19, according to a series of Statistics Canada studies from 2020.
Protection against BA.2, says Health Canada
Evushold was tested against Omicron’s BA.1, BA.1.1 and BA.2 subvariants in a recent study from the University of Washington in the United States, a study that was not reviewed by partners.
The study showed that the therapy reduced the amount of virus found in the samples, the viral load of all Omicron subvariants tested in the lungs of mice, AstraZeneca said. The study also showed that it reduces inflammation in the lungs, a critical symptom in severe COVID-19 infections.
“Evushold is expected to maintain neutralizing activity against the Omicron BA.2 sub-variant, which is now the dominant option in many communities in Canada,” Health Canada said in a statement on Thursday.
In humans, Evushold has been found to reduce the risk of developing symptomatic COVID-19 by 77 percent in studies conducted primarily before Omicron hit, the British drug regulator said last month. The defense lasted at least six months after a single dose, the British Medicines and Healthcare Regulatory Authority (MHRA) said.
The MHRA said the treatment should not be given to people infected with the SARS-CoV-2 virus that causes COVID, or those who have recently been exposed to someone with the virus.
The properties of Omicron show that it avoids the protection of the vaccine to a greater extent than previous versions, as well as dulls some monoclonal antibody treatments that have been used in some patients, such as kazirivimab / imdevimab and sotrovimab.
AstraZeneca announced in February that it had struck a deal with the federal government to supply 100,000 doses of Evushold to be delivered in 2022, pending its approval in Canada.
AstraZeneca’s partnership with Oxford University led to one of the earliest approved vaccines against COVID-19. While a rare clotting problem found in some vaccine recipients has prompted many Western countries, including Canada, to discontinue use of the vaccine, the vaccine has been given to just under three million Canadians and 67 million people worldwide, according to Health Canada. and tracking by Our World in data, respectively.
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