Game-Changing Medicine Reduces Risk of Developing Symptomatic, Severe COVID-19

According to phase 3 trial data, Evusheld, which combines two neutralizing antibodies tixagevimab with cilgavimab, significantly reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and by 83% in the six-month follow up analysis compared with placebo.

This medicine was designed specifically for adults with high risk factors or who cannot mount an adequate immune response to vaccine and is now being offered via clinical trial to children with high risk conditions or compromised immune systems. Led by principal investigator Juri Boguniewicz, MD, a pediatric infectious disease specialist, this could provide another option for adults and children who cannot be vaccinated.

Protection against symptomatic COVID-19, including omicron

Important data from a phase 3 research trial recently published in the New England Journal of Medicine and led by Myron J. Levin, MD, a pediatric infectious disease specialist at Children’s Hospital Colorado, demonstrates that one easily administered intramuscular dose of Evusheld could provide vulnerable populations of adults long-lasting protection against COVID-19, including those who are immunocompromised. In addition, Evusheld has been shown to neutralize BA.2, currently the dominant circulating COVID-19 variant. Now, this treatment is being offered to vulnerable children at Children’s Colorado through a clinical trial led by Dr. Levin’s colleague and principal investigator Dr. Boguniewicz.

“While COVID-19 vaccines have been highly effective at reducing hospitalization and death, cases continue to surge and many individuals remain at high risk, especially immunocompromised individuals and those who cannot be vaccinated,” said Dr. Levin.

“We are excited to offer this medication via clinical trial to children who are immunocompromised or otherwise at high risk of severe COVID-19 to provide them protection they otherwise would not have with a one-time injection at zero cost,” said Dr. Boguniewicz. “It’s important to note that it’s preferred that immunocompromised children receive both the vaccine and Evusheld whenever eligible, since Evusheld serves as a complement to the vaccine.”

For information related to this study, contact: AZTrustStudy@childrenscolorado.org.

Protection for at least 6 months

Evusheld is currently authorized under emergency use for preexposure prophylaxis against COVID-19 in adults and children 12 years of age and older who weigh at least 40 kilograms (88 pounds). Data also showed that adequate Evusheld concentrations in the blood remained for six months after administration, supporting that a single dose could provide long-term protection against COVID-19. A second dose has been given safely to those who were in the study after six months.

An option for those who can’t be vaccinated against COVID-19

Approximately 2% of the global population is considered at increased risk of an inadequate response to COVID-19 vaccination and may particularly benefit from pre-exposure prophylaxis (prevention) with Evusheld. This population includes people who are immunocompromised, such as cancer patients, transplant patients and anyone taking immunosuppressive medicines, and those who cannot be vaccinated. Adults and children who cannot be vaccinated and are at an increased risk of exposure to the COVID-19 virus could also benefit from protection with Evusheld. 

Evusheld is now available in many countries around the world for adults and children:

• Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination; or
• For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction to a COVID-19 vaccine(s) and/or COVID19 vaccine component(s)). 

Data supports safety of Evusheld

Evusheld was generally well tolerated with no safety issues identified in the phase 3 research trial in adults. The most common adverse reaction was injection-site reaction.