A recent news article published in the Precision Vaccinations states that Europe Recommends Another COVID-19 Monoclonal Antibody Treatment.
The recent announcement of EMA
The European Medicines Agency (EMA) human medicines committee (CHMP) recently announced its recommendation granting marketing authorization for AstraZeneca’s Evusheld to prevent COVID-19 in adults and certain adolescents.
Evusheld is made of the active substances tixagevimab and cilgavimab, two monoclonal antibodies (mAbs) designed to attach to the spike protein of the SARS-CoV-2 coronavirus at two different sites.
The virus cannot Covid 19 infection
When the antibodies in Evusheld attach to the spike protein, the virus cannot enter the cells to multiply and is unable to cause COVID-19 infection.
In reaching its conclusion on Mar. 24, 2022, the CHMP evaluated data from a study in over 5,000 people showing that Evusheld, given as two injections, reduced the risk of COVID-19 infection by 77%, with the duration of protection from the virus estimated to be at least six months.
Of the people given Evusheld, 0.2% had lab-confirmed breakthrough COVID-19 following treatment.
When was the study data collected?
However, this study data were collected before the emergence of the Omicron virus variant.
But, AstraZeneca announced on Mar. 21, 2022, preclinical authentic ‘live’ virus data from Washington University School of Medicine demonstrated that Evusheld retains potent neutralizing activity against the Omicron BA.1 and BA.2 subvariants.
In the U.S., the Food and Drug Administration issued an emergency use authorization for Evusheld on Dec. 8, 2021.
Since then, about 848,000 doses of Evusheld have been shipped in the U.S.
On Feb. 24, 2022, the FDA increased the initial authorized dose to 300 mg of tixagevimab and 300 mg of cilgavimab.
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Source: Precision Vaccinations
