Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections. Allocation of Evusheld is made to U.S. states and territories by the US Department of Health and Human Services (HHS). If you develop signs or symptoms of COVID-19, reach out to your doctor, another healthcare provider, or a Duggan stressed Evusheld is not a substitute for vaccines for people who just don't want them. She still doesn't go to the grocery store. She faxed doctor's notes to various hospitals and zeroed in on the University of Maryland hospital, which had the most doses. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose. FDA will continue to work with ASPR, the CDC, and the National Institutes of Health on surveillance of variants that may impact the use of the therapies authorized for emergency use. Health > All Health Topics > Diseases & Conditions > Coronavirus > Prevention-Treatment-Provider. It is also used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. "I haven't been inside of a grocery store for over a year.". To best protect those most at risk from COVID-19, Monash Health will expand its Evusheld clinic with four additional clinics in July 2022. Follow, FDA has also updated the list of medical conditions or treatments that may result in moderate to severe immune compromise. Date of report (date of earliest event reported): February 13, 2023. Patients with any additional questions should contact their health care provider. But the infusion center was out of network with her health plan, so she had to pay a nearly $200 administration fee. Evusheld is authorized for the emergency use as pre-exposure prophylaxis (PrEP) for prevention of COVID-19 in certain adults and pediatric patients (12 years of age and older weighing at least 40 kg). CLL Society Inc. is a patient-centric, physician-curated nonprofit organization focused on patient education, support, and research. On December 20, the Centers for Disease Control and Prevention (CDC) issued a, On January 10, 2023, NIHs COVID-19 Treatment Guidelines Panel released a. Sacramento, CA 95899-7377, For General Public Information: Evusheld is available for people who are at least 12 years old, weigh at least 88 pounds, and are moderately to severely immunocompromised or unable to receive covid vaccines for medical reasons.. Please turn on JavaScript and try again. Evusheld Sites as of 01/10/2022 . Through the additional data cut-off in thePROVENT trial(median follow-up 6.5 months), a higher proportion of subjects who received Evusheld reported cardiac severe adverse events compared to placebo. COVID-19 convalescent plasma may be another option for certain immunocompromised patients. Currently, the Omicron BA.2, BA.2.12.1, BA.4, and BA.5 subvariants are circulating in the United States. FDA continues to recommend Evusheld as an appropriate option for PrEP to prevent COVID-19, in combination with other preventative measures like getting vaccinated and boosted as recommended, as Evusheld still offers protection against many of the currently circulating variants and may offer protection against future variants. The cost of Evusheld itself is covered by the federal government. For further details please refer to the Frequently Asked Questions forEvusheld. Fact Sheet for Healthcare Providers. It's helping her feel like she has earned hers. "We put everybody's name into a lottery," she explains. Talk with your health care provider about appropriate treatment options in case you develop COVID-19. About 7 million adults in the US are immune-compromised and could benefit from Evusheld, according to its manufacturer, AstraZeneca. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) The U.S. government recommends that all products be retained in the event that SARS-CoV-2 variants susceptible to Evusheld become more prevalent in the future in the U.S. Evusheld is not currently authorized in any U.S. region due to the many SARS-CoV-2 variants that are not susceptible to Evusheld. A healthcare provider gives Evusheld as two separate, consecutive intramuscular injections at a doctors office or healthcare facility. People 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. Should begin within 7 days of symptoms onset. The conditions listed in the, who have moderate-to-severe immune compromise due to a medical condition or who have received immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or. Evusheld is currently the only option for pre-exposure prophylaxis (PrEP) of COVID-19 and is authorized under Emergency Use Authorization (EUA) for use in immunocompromised individuals who may not mount an adequate response to COVID-19 vaccination, and for individuals for whom COVID-19 vaccination is not recommended due to a history of a severe adverse reaction. Patients with any additional questions should contact their health care provider. The FDA also recently issued an EUA for Evusheld, developed by AstraZeneca, the first preventive (prophylaxis) treatment for moderately to severely immunocompromised individuals who do not have COVID-19. Through this program, people have access to "one-stop" test and treat locations. It is authorized to be administered every six months. . The PROVENT trial enrolled individuals having increased risk for inadequate response to immunization or having increased risk for SARS-CoV-2 infection. Evusheld is a key piece of the Biden administration's strategy to protect the more than seven million Americans with weakened immune systems. . We will provide further updates and consider additional action as new information becomes available. This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. If vaccination is recommended for you, get vaccinated and stay up to date to protect yourself against COVID-19. Evusheld (tixagevimab/cilgavimab) is a treatment made by the pharmaceutical company AstraZeneca. EVUSHELD is an investigational medicine used in adults and adolescents 12 years of age and older who weigh at least 88 pounds for preexposure prophylaxis for prevention of . Second, develop a It is likely that Evusheld dose recommendations will be regularly updated as the circulating variants change and providers should review the FDA's 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). for whom vaccination with any available approved or authorized COVID-19 vaccine is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s). We will provide further updates as new information becomes available. Administration: Evusheld is administered as two separate 3.0-mL (300 mg/300 mg) gluteal intramuscular injections Patients should receive repeat dosing every 6 months Platelet count >30,000 cells/mm3 required We are encouraging states to support local health departments and health systems in setting up infusion clinics for Veklury (remdesivir) to make it easier for people to get this treatment as soon as possible after being diagnosed with COVID-19. We have not had to go to a lottery system. Evusheld Not Authorized in U.S. for Current SAR-CoV-2 Subvariants On January 26, 2023, the Food and Drug Administration (FDA) announced that Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorized for emergency use in the U.S. Based on current data, it is unlikely to be active against more that 90 percent of the SARS- 200 Independence Ave., Washington, DC 20201. "Unfortunately, the initial allocations in my state did not go to the largest transplant or cancer center despite the fact that Miami-Dade County is the center of a large transplant population," says Michele Morris, an infectious disease physician who cares for organ and stem cell transplant patients at Jackson Memorial Hospital and the Sylvester Comprehensive Cancer Center. Under FDA guidelines, those eligible for Evusheld are people whose immune systems are moderately or severely compromised because of a medical condition or the use of immune-suppressing. Initial availability will be through the federal government, which has purchased 700,000 doses to be distributed to states based on their populations. Recent data show Evusheld is unlikely to be active against certain SARS-CoV-2 variants. This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. Health care professionals should review the updated Fact Sheets and Dear Health Provider Letter for Evusheld. It's an alternative option for . Why did FDA take action to pause the authorization of Evusheld? Based on this revision, Evusheld is not currently authorized for use in the U.S. until further notice by the Agency. Select pharmacies and federally qualified health centers will provide rapid COVID-19 testing. The Mayo Clinic, in Rochester, Minn., has a similar system with five tiers and randomized selections within them says Dr. Raymund Razonable, who runs its monoclonal antibody treatment program. Data availability statement. 1-833-4CA4ALL Early data suggests it may work less well against the omicron variant of the coronavirus, but it is still expected to offer some protection. Analyze with charts and thematic maps. The government is making it available through pharmacies and individual providers. The original contributions presented in the study are included in the article/supplementary material. The National Institutes of Health (NIH) treatment guidelines on [2/24/2022]The U.S. Food and Drug Administration has revised the emergency use authorization forEvusheld (tixagevimab co-packaged with cilgavimab)to change the initial dose for the authorized use as pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric patients.