Since the declaration of the COVID-19 public health emergency in early 2020, four monoclonal antibody products have been approved in the European Union for the prevention and treatment of COVID-191,2,3,4. A recommendation under Article 5(3) was issued for a fifth product5.
These monoclonal antibody therapies are composed of one or more different neutralising antibodies. They are designed to bind to the spike protein of SARS-CoV-2 and thereby interfere with the ability of the virus to attach to and enter the host cells. They have been proven to prevent the risk of symptomatic COVID-19 infection in the context of pre-exposure or post-exposure prophylaxis1,2, and to reduce the risk of progression to severe disease, hospitalisation and death in patients with early disease not requiring supplemental oxygen and who are at an increased risk for progressing to severe COVID-19 disease1,2,3,4…
