|AstraZeneca’s Evusheld receives emergency authorisation in the US for pre-exposure prophylaxis of COVID-19. — Photo courtesy of AstraZeneca Vietnam|
HCM CITY — AstraZeneca has announced that its Evusheld, a long-acting antibody combination, has received emergency use authorisation (EUA) in the US for the pre-exposure prophylaxis of COVID-19, with first doses expected to become available very soon.
The Food and Drug Administration (FDA) granted the EUA for Evusheld for pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 and older who weigh 40kg or more, with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as for those individuals for whom COVID-19 vaccination is not recommended.
Myron J Levin, MD, professor of pediatrics and medicine, University of Colorado School of Medicine, US, and principal investigator on the PROVENT trial, said: “Millions of people in the US and around the world remain at serious risk for COVID-19 because their immune systems do not generate a sufficient immune response, even after receiving all recommended doses of vaccine. I am excited to offer my patients Evusheld as an easily administered new option that provides long-lasting protection that could help them return to their everyday lives.”
Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US for COVID-19 pre-exposure prophylaxis and the only COVID-19 antibody delivered as an intramuscular dose.
About 2 per cent of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine. About seven million people in the US are immunocompromised and may benefit from Evusheld for pre-exposure prophylaxis of COVID-19.
This includes people with blood cancers or other cancers being treated with chemotherapy, and those taking medications after an organ transplant or who are taking immuno-suppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.
The primary data supporting the Evusheld EUA are from the ongoing PROVENT Phase III pre-exposure prevention trial, which showed a statistically significant reduction for the risk of developing symptomatic COVID-19 compared to the placebo, with protection from the virus continuing for at least six months. More follow-up is needed to establish the full duration of protection provided by Evusheld.
AstraZeneca has agreed to supply the US Government with 700,000 doses of Evusheld. The US Government has indicated that it plans to distribute these doses to states and territories at no cost and on a pro rata basis. — VNS