This is another therapy that has been shown to be effective in protecting those most vulnerable to COVID-19, and signals another important step forward in our fight against this devastating disease. Without compromising on quality, safety and efficacy, the public can have confidence that the MHRA has conducted a solid and in-depth assessment of all available data, she said.
Sotrovimab is given as a 30-minute intravenous infusion and is approved for people 12 years of age and older who weigh more than 40 kg. The MHRA has said it is too early to know whether the Omicron variant has an impact on the effectiveness of sotrovimab, but it plans to work with manufacturers to establish this.
But based on preliminary lab studies, the researchers say the drug targets a part of the virus’s spike protein that has not yet undergone any big changes or mutations, which means it should work well against all variants.
In a clinical trial, a single dose of the monoclonal antibody was found to reduce the risk of hospitalization and death by 79% in high-risk adults with symptomatic COVID-19 infection. Based on clinical trial data, sotrovimab is most effective when taken during the early stages of infection and therefore the MHRA recommends its use as soon as possible and within five days of symptom onset.