The Food and Drug Administration (FDA) has approved Evusheld for the pre-exposure prophylaxis of COVID-19 in a selected group of individuals of 12 years of age, and older who weigh at least 40 kg. This article throws light on the effectiveness and safety of the monoclonal antibody intramuscular injection.

Pre-exposure prophylaxis for COVID-19 - Evusheld has been approved for certain individuals

Evusheld (tixagevimab co-packaged with cilgavimab) is a monoclonal antibody cocktail composed of two long-acting monoclonal antibodies that recognise different locations on the SARS-CoV-2 spike protein. The product is approved for individuals who are not currently infected with SARS-CoV-2 and have had no known recent exposure to an infected individual, and who:

1. Are moderate to severe immune-compromised as a result of a medical condition or are using immunosuppressive medications or treatments and may be unable to mount an adequate immune response to COVID-19 vaccination; or
2. For whom vaccination with any available COVID-19 vaccine, according to the approved schedule, is not an option.

Dosage

The permitted dosage of Evusheld for pre-exposure prophylaxis is 150 mg of tixagevimab and 150 mg of cilgavimab provided as two separate consecutive intramuscular injections. Evusheld is not approved for use in humans for the treatment or prophylaxis of COVID-19.

The Evusheld study

The EUA was based on primary data from the phase 3 PROVENT study (ClinicalTrials.gov Identifier: NCT04625725), which evaluated the effectiveness and safety of Evusheld to placebo in people 18 years of age and older for pre-exposure COVID-19 prophylaxis. PROVENT data showed that therapy with Evusheld significantly decreased the chance of acquiring symptomatic COVID-19 by 77% when compared to placebo.

Additionally, healthcare practitioners should weigh the risks and advantages of Evusheld in patients at high risk for cardiovascular events. In PROVENT, patients who took Evusheld had a greater risk of significant cardiovascular adverse events, including myocardial infarction and cardiac failure, compared to those who got placebo; a direct association between the medication and these events has not been proven.

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.