Singapore grants interim authorisation for AstraZeneca’s antiviral mAb Evusheld

The Health Sciences Authority (HSA) in Singapore, in consultation with its Medicines Advisory Committee, has granted an interim authorisation under the Pandemic Special Access Route (PSAR) for AstraZeneca’s antiviral monoclonal antibody, Evusheld. Evusheld comprises two monoclonal antibodies, namely tixagevimab co-packaged with cilgavimab, & is administered by intramuscular injection. It is authorised to be used for the prevention of COVID-19 in adults who have not had a known recent exposure to an individual with COVID-19 infection (preexposure prophylaxis) & are unlikely to mount an adequate immune response to COVID-19 vaccination due to a medical condition or are taking immunosuppressive medications or treatments or for whom COVID-19 vaccination is not recommended. Examples of such people include those who are in an immunocompromised state from blood or bone marrow transplants or have human immunodeficiency virus (HIV) infections. However, pre-exposure prophylaxis with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. The treatment must be prescribed by a doctor and the suitability of use on the individual patient will require a careful clinical assessment by the prescribing doctor.