NETHERLANDS – The European Union’s drug watchdog has recommended for approval AstraZeneca’s Covid-19 prevention cocktail, which can be used for patients with immune system problems or severe reactions to other coronavirus vaccines.
The European Medicines Agency’s human medicines committee “has recommended granting a marketing authorization for Evusheld, developed by AstraZeneca for the prevention of Covid-19 in adults and adolescents from 12 years of age,” the Amsterdam-based EMA said in a statement.
Evusheld consists of two monoclonal antibodies tixagevimab and cilgavimab — proteins designed to attack the spike protein of the Sars-CoV-2 virus, which causes COVID-19 — at two different sites, the EMA said.
It said data from a test on 5,000 people who were given two jabs, showed it reduced the risk of COVID-19 infection by 77 per cent and protection lasted for at least six months.
The study was done on adults who had never had COVID-19 and had never received a vaccine or other preventative treatment, the EMA said.
“The safety profile of Evusheld was favorable and side effects were generally mild, with a small number of people reporting reactions at the injection site or hypersensitivity,” the medicines watchdog added.
The EMA’s recommendation will now be forwarded to the European Commission for final approval before distribution to the 27-member bloc.
Keeping eye on Omicron subvariants
According to the EMA, the study data were gathered prior to the emergence of the Omicron BA.2 subvariant, which is currently driving COVID-19 infections worldwide.
“Laboratory studies show that the Omicron BA.1 variant may be less sensitive to [Evusheld] at 150mg doses than [BA.2],” the watchdog said, adding that it will evaluate data “in the coming weeks” to determine whether an alternative dosing regimen is required.
Earlier this week, Washington University researchers demonstrated that Evusheld “retains potent neutralizing activity” against BA.2, which AstraZeneca claims accounts for nearly 60% of COVID-19 infections in Europe.
The study discovered that Evusheld significantly reduced viral burden and limited inflammation in the lungs across all Omicron subvariants.
Evusheld is currently approved for emergency use for COVID-19 pre-exposure prophylaxis in the United States and a few European countries, including the United Kingdom, where it was granted conditional marketing authorization last week.
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