Brasilia, March 7 (Prensa Latina) Brazil’s National Health Surveillance Agency (Anvisa) reported today that it has temporarily suspended emergency use of the Evusheld drug against Covid-19, which is manufactured by Anglo-Swedish company AstraZeneca.
First approved for prophylactic indication in February 2022, the agent is a combination of two monoclonal antibodies (cilgavimabe + tixagevimabe) and its administration is via intramuscular injection.
According to Anvisa, the measure comes after data provided by the laboratory showed a significant drop in the drug’s effectiveness against the worrying variants of the new SARS-CoV-2 coronavirus circulating in the country.
The suspension was unanimous in a collegial direction of the regulator and will remain in effect until data are presented demonstrating the vaccine’s validity against the variants.
Evusheld has indications for use in the pre-exposure prophylaxis and treatment of Covid-19 in mild to moderate cases in patients at high risk of disease progression and exacerbation.
Also last January, the United States withdrew emergency use approval for the drug.
At the time, the Food and Drug Administration (FDA), an entity equivalent to Anvisa, stated that the agent did not neutralize subvariants of Ómicron, as does XBB.1.5.1, which is prevalent in the country.
AstraZeneca reported in the same month that it is testing a new drug in clinical trials that can neutralize new strains of SARS-CoV-2 and is also said to help prevent the disease.
In the case of Brazil, Anvisa cited the current prevalence of 77 percent of BQ.1 variants and 15 percent of BA.5 variants to temporarily suspend the use permit.
The agency also pointed out that if there are batches of the drug on the national territory, the company holding the license must duly inform healthcare professionals about the ineffectiveness of the drug against the circulating variants of SARS-CoV-2.
To date, the South American giant has recorded 699,276 deaths and 37,76,073 infections from Covid-19 since entering the country in February 2020.
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