Addressing the unmet needs of the immunocompromised as COVID-19 restrictions ease

(BPT) – While COVID-19 restrictions continue to ease across the country and the pandemic begins to subside for many, a group of people remain “left behind.” Despite the battle to bolster immunity and prevent severe illness or death from COVID-19, many immunocompromised individuals remain insufficiently protected.1While COVID-19 vaccinations can protect a majority of the population, 3% of adults in the United States are considered immunocompromised and at the highest risk for COVID-19,2 including those who have received a solid organ or bone marrow transplant, are on active chemotherapy or other immunosuppressive drugs, have advanced or untreated HIV, or who have a primary immune deficiency.3 These individuals may be unable to mount an adequate immune response to vaccines, leaving them vulnerable to COVID-19.1 In the weeks following vaccination, their immune systems may react, but not produce enough antibodies to protect against COVID-19 in the event of an exposure.1There are therapies, however, such as long-acting monoclonal antibodies, that may help immunocompromised individuals, by providing additional protection prior to virus exposure.4Another option in the fight against COVID-19 Unlike a vaccine that helps stimulate and prepare your immune system to respond if you are exposed to a virus, monoclonal antibodies imitate the body’s normal infection-fighting abilities.4While these antibodies do not replace a vaccine, when used as prophylaxis (prevention), they can be a helpful tool in protecting high-risk individuals from severe COVID-19 outcomes.4EVUSHELDTM (tixagevimab co-packaged with cilgavimab) is a long-acting monoclonal antibody combination authorized for emergency use during the COVID-19 pandemic. EVUSHELD is for certain people with moderate to severe immune compromise for prevention of COVID-19 before being exposed to the virus and can be used in addition to vaccinations. EVUSHELD is not authorized for post-exposure prophylaxis or treatment of COVID-19.5EVUSHELD has shown neutralizing activity against the Omicron variant, which is the current dominant circulating variant globally.6,7 The duration of protection from EVUSHELD may change with certain viral variants. Prescribing healthcare providers should consider the prevalence of SARS-CoV-2 variants in their area, where data are available, when considering prophylactic treatment options.6Available resources for patients Alongside the Centers for Disease Control and Prevention’s (CDC) recommended preventative measures like wearing a mask, social distancing and getting vaccinated, immunocompromised individuals can protect themselves from COVID-19 by receiving therapies like EVUSHELD.6,8EVUSHELD is still being studied, so it is possible that all the risks are not known at this time. Allergic reactions can happen during and after injection of EVUSHELD. These reactions may be severe or life-threatening.In clinical trials, serious cardiac events have happened more often in people with cardiac risk factors who received EVUSHELD than in those who did not receive EVUSHELD.EVUSHELD is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of EVUSHELD under Section 564(b)(1) of the Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.To learn more, speak with your healthcare provider to find out if you’re a candidate for monoclonal antibodies such as EVUSHELD and visit EVUSHELD.com for more information. To find out if EVUSHELD is available in your local area, visit the US HHS COVID-19 Therapeutics Locator to locate an authorized provider near you.Please see the Fact Sheet for Patients, Parents and Caregivers to learn more.IMPORTANT SAFETY INFORMATIONDo not take EVUSHELD if you have had a severe allergic reaction to EVUSHELD.What are the important possible side effects of EVUSHELD?Allergic reactions: Allergic reactions can happen during and after injection of EVUSHELD and can sometimes be serious or life-threatening. You may be at an increased risk of an allergic reaction to EVUSHELD if you have had a severe allergic reaction to a COVID-19 vaccine or to a vaccine component. Your healthcare provider may consult with an allergist-immunologist before giving you EVUSHELD if you have had a serious allergic reaction to a COVID-19 vaccine.Tell your healthcare provider right away if you get any of the following signs and symptoms of an allergic reaction during or after you receive EVUSHELD:Trouble breathing or shortness of breathWheezingChillsItchingTiredness or weaknessSkin flushingFast heart rateSweatingChest pain or discomfortMuscle achesNausea and vomitingYou may feel lightheaded or faintSwelling of your face, lips, mouth and tongueThroat tightnessHives Cardiac (heart) events:In the clinical trial for EVUSHELD, more people with cardiac risk factors (including a history of heart attack) experienced serious cardiac events than those who did not receive EVUSHELD.It is not known if these events are related to EVUSHELD or to underlying medical conditions. Contact your healthcare provider or get medical attention right away if you get any symptoms of cardiac events, including pain, pressure, or discomfort in the chest, arms, neck, back, stomach or jaw, as well as shortness of breath, feeling tired or weak (fatigue), feeling sick (nausea), or swelling in your ankles or lower legs.The side effects of getting any medicine by intramuscular injection may include pain, bruising of the skin, soreness, swelling and possible bleeding or infection at the injection site.These are not all the possible side effects of EVUSHELD. Not a lot of people have been given EVUSHELD. Serious and unexpected side effects may happen. EVUSHELD is still being studied, so it is possible that all the risks are not known at this time.It is possible that EVUSHELD may reduce your body’s immune response to a COVID-19 vaccine. If you have received a COVID-19 vaccine, you should wait to receive EVUSHELD until at least 2 weeks after COVID-19 vaccination.Before you receive EVUSHELD, tell your healthcare provider about all your medical conditions, including if you:Have any allergies, including if you have had a severe allergic reaction to a COVID-19 vaccineHave low numbers of blood platelets (which help blood clotting), a bleeding disorder, or are taking anticoagulants (to prevent blood clots)Have had a heart attack or stroke, have other heart problems, or are at high-risk of cardiac (heart) eventsAre pregnant or plan to become pregnantAre breastfeeding a childHave any serious illnessesAre taking any medications (prescription and over-the-counter medicines, vitamins and herbal products)What if I am pregnant or breastfeeding?If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.What prevention choices are there?Vaccines to prevent COVID-19 are approved or available under Emergency Use Authorization. Use of EVUSHELD does not replace vaccination against COVID-19.It is your choice to receive or not receive EVUSHELD. Should you decide not to receive EVUSHELD, it will not change your standard medical care.AUTHORIZED USEEVUSHELD is an unapproved medicine used in adults and adolescents (12 years of age and older who weigh at least 88 pounds [40 kg]) for pre-exposure prophylaxis for prevention of COVID-19 in persons who are:not currently infected with SARS-CoV-2 and who have not had recent known close contact with someone who is infected with SARS-CoV-2 andWho have moderate to severe immune compromise due to a medical condition or have received immunosuppressive medicines or treatments and may not mount an adequate immune response to COVID-19 vaccination orFor 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 to a COVID-19 vaccine(s) or COVID-19 vaccine ingredient(s).EVUSHELD is investigational because it is still being studied. There is limited information known about the safety and effectiveness of using EVUSHELD for pre-exposure prophylaxis for the prevention of COVID-19. EVUSHELD is not authorized for post-exposure prophylaxis for prevention of COVID-19.The FDA has authorized the emergency use of EVUSHELD for pre-exposure prophylaxis for prevention of COVID-19 under an Emergency Use Authorization.How do I report side effects with EVUSHELD?Contact your healthcare provider if you have any side effects that bother you or do not go away. Report side effects to FDA MedWatch or call AstraZeneca at 1-800-236-9933.You may report side effects related to AstraZeneca products by clicking here.References Haidar G, Agha M, Bilderback A, et al. Prospective evaluation of COVID-19 vaccine responses across a broad spectrum of immunocompromising conditions: the COVICS study [published online ahead of print, 2022 Feb 18]. Clin Infect Dis. 2022; ciac103. doi:10.1093/cid/ciac103, Accessed June 13, 2022.Harpaz R, Dahl RM, Dooling KL. Prevalence of Immunosuppression Among US Adults, 2013. JAMA. 2016 Dec 20;316(23):2547-2548. doi: 10.1001/jama.2016.16477. Accessed June 15, 2022.Covid-19 vaccines for people who are moderately or severely immunocompromised. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html?s_cid=10483%3Aimmunocompromised+and+covid+vaccine%3Asem.ga%3Ap%3ARG%3AGM%3Agen%3APTN%3AFY21. Accessed May 26, 2022.Taylor PC, Adams AC, Hufford MM, de la Torre I, Winthrop K, Gottlieb RL. Neutralizing monoclonal antibodies for treatment of COVID-19. Nat Rev Immunol. 2021;21(6):382-393. doi:10.1038/s41577-021-00542-x. Accessed June 15, 2022.US Food and Drug Administration FACT SHEET FOR PATIENTS, PARENTS AND CAREGIVERS: EMERGENCY USE AUTHORIZATION (EUA) of EVUSHELDTM (Tixagevimab Co-Packaged with Cilgavimab) for Coronavirus Disease 2010 (COVID-19). Available at: https://www.fda.gov/media/154701/download. Accessed June 15, 2022.US Food and Drug Administration FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR EVUSHELDTM (Tixagevimab Co-Packaged with Cilgavimab). Available at: https://www.fda.gov/media/154701/download. Accessed June 15, 2022.World Health Organization. (n.d.). Tracking sars-COV-2 variants. World Health Organization. Available at https://www.who.int/activities/tracking-SARS-CoV-2-variants. Accessed June 15, 2022.Centers for Disease Control and Prevention. (n.d.). How to protect yourself & others. Centers for Disease Control and Prevention. Retrieved June 15, 2022, from https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Accessed June 15, 2022EVUSHELD is a trademark of the AstraZeneca group of companies.©2022 AstraZeneca. All rights reserved.