Everything you need to know about FDA’s newly authorized Long-Acting Monoclonal Antibodies, known as AstraZeneca’s Evusheld for COVID prevention.

The US Food and Drug Administration has approved AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) an emergency use authorization (EUA) for the pre-exposure prophylaxis (prevention) of COVID-19 in specific individuals and pediatric patients (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).

The product is only approved for people who are not presently infected with SARS-CoV-2 and have not recently been exposed to someone who is infected with SARS-CoV-2.

Individuals must additionally have one of the following conditions:

• Due to a medical condition or the use of immunosuppressive medications or treatments, people with moderate to severely compromised immune systems may not be able to mount an adequate immune response to COVID-19 vaccination. or;
• a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines, therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.

“Vaccines have proven to be the best defense available against COVID-19. However, there are certain immune compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option,” says Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.

“Today’s action authorizes the use of the combination of two monoclonal antibodies to reduce the risk of developing COVID-19 in these individuals.” 

For pre-exposure prevention, one dose of Evusheld delivered as two separate intramuscular injections (one injection per monoclonal antibody, given in rapid succession) may be effective for six months. Individuals are not permitted to use Evusheld for the treatment of COVID-19 or for COVID-19 post-exposure prophylaxis. Patients should discuss whether Evusheld is an appropriate pre-exposure preventive option with their health care physician.

In those for whom COVID-19 vaccination is suggested, pre-exposure prophylaxis with Evusheld is not a substitute for immunization. The FDA has licensed one vaccine and permitted the use of others to prevent COVID-19 infection and the serious clinical outcomes that come with it, such as hospitalization and death. If you are eligible, the FDA recommends that you get vaccinated.

“Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that Evusheld may be effective for use as pre-exposure prevention in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms). The agency has also determined that the known and potential benefits of Evusheld, when used consistent with the terms and conditions of the authorization, outweigh the known and potential risks of the product. There are no adequate, approved and available alternatives to Evusheld for the pre-exposure prevention of COVID-19 in the authorized population,” the agency said.

The primary data supporting this EUA for Evusheld come from PROVENT, a randomized, double-blind, placebo-controlled clinical trial in adults over the age of 59 or with a predetermined chronic medical condition or at increased risk of SARS-CoV-2 infection for other reasons who had not received a COVID-19 vaccine and did not have a history of SARS-CoV-2 infection or test positive for SARS-CoV-2 infection at the start of the trial. The primary endpoint of the trial was whether or not a trial participant developed a first case of COVID-19 after receiving Evusheld or a placebo before day 183 of the trial. In this study, 3,441 patients were given Evusheld and 1,731 were given a placebo. In the primary analysis, Evusheld users had a 77% lower probability of acquiring COVID-19 when compared to placebo recipients, a statistically significant difference. Additional studies found that Evusheld participants had a lower probability of having COVID-19 after six months. The safety and efficacy of Evusheld in the pre-exposure prophylaxis of COVID-19 are still being studied.

Side effects of AstraZeneca’s Evusheld

Hypersensitivity reactions (including anaphylaxis), bleeding at the injection site, headache, fatigue, and cough are all possible adverse effects of Evusheld. 

In PROVENT, serious cardiac adverse effects were uncommon. However, when compared to placebo, more trial participants experienced significant cardiac adverse events (such as myocardial infarction and heart failure) after using Evusheld. Before taking part in the clinical trial, all of these participants had risk factors for heart disease or a history of cardiovascular disease. It is unclear whether Evusheld was the cause of these cardiac incidents.

Source: FDA

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