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Singapore grants interim authorisation for AstraZeneca’s antiviral mAb Evusheld

05 August 2022 | News

For pre-exposure prevention of COVID-19 in adults who are medically unsuitable for vaccination

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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, and 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 (pre- exposure prophylaxis) and are unlikely to mount an adequate immune response to COVID‐19 vaccination due to their moderate to severe immunocompromised state from a medical condition or receipt of immunosuppressive medications or treatments1; or, for whom COVID-19 vaccination is not recommended.

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.

As a condition for the interim authorisation under PSAR, AstraZeneca is required to collect and submit the relevant safety data from ongoing clinical studies to ensure the continued safety and efficacy of Evusheld, including its efficacy against prevailing variants. 

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