The EU’s drug watchdog on Thursday 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 authorisation 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 percent 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 favourable and side effects were generally mild, with a small number of people reporting reactions at the injection site or hypersensitivity,” the medicines watchdog added.
But the study was done before the emergence of the infectious Omicron strain of the virus and “laboratory studies show that the Omicron BA.1 variant may be less sensitive to tixagevimab and cilgavimab than the Omicron BA.2 variant,” the watchdog said.
The EMA’s recommendation will now be forwarded to the European Commission for final approval before distribution to the 27-member bloc.
Evusheld received the US-based FDA’s emergency authorisation in December.