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The European Medicines Agency (EMA) has recommended approval of a CoV drug from AstraZeneca to protect at-risk patients who cannot be vaccinated from infection. The Committee for Human Medicines recommended marketing authorization for Evusheld “to prevent covid-19 in adults and adolescents aged 12 years and over and weighing 40 kilograms or more”, the agency said today.
Evusheld consists of two synthetic antibodies that can dock to different sides of the coronavirus spike protein. In making its decision, the EMA pointed to a study of 5,000 adults whose risk of infection was reduced by 77 percent after receiving two doses of the vaccine. According to the EMA, the protection lasted at least six months, and the side effects were “generally low.“
However, the study was from before the advent of the Omikron variant. According to the European Medicines Agency, laboratory studies indicate that the omicron subvariant BA.1 is “less sensitive” to the drug than the BA.2 subvariant.
The EMA’s recommendation will now be forwarded to the European Commission. Evusheld had already received emergency approval from the US Food and Drug Administration (FDA).
- source: ORF.at/picture: pixabay.com
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