Health care professionals should review the updated Fact Sheets and Dear Health Provider Letter for Evusheld. To best protect those most at risk from COVID-19, Monash Health will expand its Evusheld clinic with four additional clinics in July 2022. 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. Health care providers should only administer it to individuals who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to someone infected with SARS-CoV-2. It also means that her body didn't really make antibodies in response to two shots she got of the Moderna COVID-19 vaccine. If those medicines are not available or someone cannot take them, Lagevrio (molnupiravir) is the next choice. The government distributed about 50,000 doses of Evusheld this week, on top of about 100,000 doses in December. Evusheld is a medicine used to prevent COVID-19 in adults and adolescents (from 12 years of age weighing at least 40 kilograms). hide caption. Information about circulating variants can be found through CDC Nowcast data. Should a patient become infected with SARS-CoV-2 and develop symptoms of COVID-19, they should seek medical attention, including starting treatment for COVID-19 as appropriate. 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. 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 Cheung now advocates online for Evusheld doses for others. "It's [Evusheld] got a long half-life so you are protected for about 120 days and it's incredibly effective against omicron, particularly, so it's really important," she said. Evusheld is only authorized for those: The duration of protection provided by Evusheld against symptomatic SARS-CoV-2 infection may not be as long as was shown in the clinical trial supporting the initial authorization because the clinical trial data came from a time period before the emergence of the BA.1 and BA.1.1 subvariants. And like other viruses, SARS-CoV-2 can mutate over time, resulting in certain products not working against certain variants. The Disability Information and Access Line (DIAL) is also available to specifically help people with disabilities access services. 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. This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants. What is HHS doing to ensure access to treatments for individuals who are immunocompromised or who cannot get vaccinated now that Evusheld is no longer available? My neurologist has some available and I will be talking to them tomorrow morning. 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. EVUSHELD is also being studied as a potential treatment for hospitalized COVID-19 patients as part of the National Institute of Health's ACTIV-3 trial and in an additional collaborator hospitalization treatment trial. 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. 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. Advisory Board's Andrew Mohama dives into why this is happening, and potential solutions moving forward. TONIX PHARMACEUTICALS . Where can I find additional information on COVID-19 treatment & preventive options? According to the most recent CDC Nowcast data, these variants are projected to be responsible for more than 90% of current infections in the U.S. Health care professionals should inform patients of this risk and advise patients who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and promptly seek medical attention, including starting treatment for COVID-19, as appropriate if they test positive. 200 Independence Ave., Washington, DC 20201. Ted S. Warren/Associated Press "It is overwhelming. Department of Health Services (DHS) is partnering with the federal government on a new Test to Treat program as part of the National COVID-19 Preparedness Plan. This work is particularly important for people who are unable to get vaccinated and for immunocompromised people who may not mount an adequate immune response to vaccination. Molnupiravir. There are several treatments Paxlovid, Veklury (remdesivir) and Lagevrio (molnupiravir) that are expected to work against currently circulating variants, and that are authorized or approved to treat certain patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Follow, FDA has also updated the list of medical conditions or treatments that may result in moderate to severe immune compromise. IV infusion. We continue to monitor the neutralizing activity of Evusheld against emerging SARS-CoV-2 variants and will provide additional updates as needed. Before administering Evusheld to individuals with a history of severe hypersensitivity reactions to a COVID-19 vaccine, consultation with an allergist/immunologist should be considered. Shelf-life extensions were issued for specific lots of Evusheld. Queens . Health > All Health Topics > Diseases & Conditions > Coronavirus > Prevention-Treatment-Provider. Health care professionals should review the updated Fact Sheets and Dear Health Provider Letter for Evusheld. FDA is committed to working with industry sponsors to expedite the development of new drug products to meet unmet needs, such as the need for new preventive therapies for immune suppressed patients who are unlikely to respond to vaccination. Health care providers should only administer it to individuals who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to someone infected with SARS-CoV-2. If recommended by your health care provider, get vaccinated or boosted with a bivalent booster dose to help your body increase your protection against SARS-CoV-2 infection. You should also talk with your doctor in advance about what treatments may be appropriate for you and how to access the medication if you experience symptoms. Todays action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product. Evusheld is administered via two intramuscular injections given at the same time. Individual providers and smaller sites of care that do not currently receive Evusheld through the HHS Health Partner Order Portal (or HPOP) distribution process can now order small, limited quantities of product (1-3 patient courses). Evusheld, a course of injected antibodies, helps protect people with weak immune systems for up to six months. This service will help to determine whether COVID-19 oral antiviral medicine is right for you. 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. Health care providers should inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 variants not neutralized by Evusheld. Available therapeutic treatments The Department of Health and Human Services, which manages the process, did not respond to questions about supply and distribution. The vaccine causes the body's immune system to make protective antibodies, while Evusheld provides the antibodies. However, we are awaiting additional data to verify that Evusheld is not active against XBB.1.5. There are Sacramento, CA 95899-7377, For General Public Information: Health care professionals should contact patients who received the previously authorized Evusheld dose to return for an additional 150 mg tixagevimab and 150 mg cilgavimab dose as soon as possible. AstraZeneca has established a helpline to receive additional general product information as well as specific guidance on how to access the product, including information on ordering. Patients who have already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive an additional dose of 150 mg of tixagevimab and 150 mg of cilgavimab as soon as possible to raise their monoclonal antibody levels to those expected for patients receiving the higher dose. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) On April 25, 2022, the FDA expanded the approval to pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing. The latest CDC NOWCAST estimate shows that these variants are causing more than 90% of the cases today. The long-acting AstraZeneca therapy known as Evusheld will be available to moderately to severely immunocompromised people like cancer patients, he said. Update [1/6/2023] FDA is closely monitoring the emergence of the XBB.1.5 subvariant, a SARS-CoV-2 Omicron variant that is currently estimated to account for 28% of circulating variants in the U.S. Because of its similarity to variants that are not neutralized by Evusheld (e.g., XBB), FDA does not anticipate that Evusheld will neutralize XBB.1.5. Allocation of Evusheld is made to U.S. states and territories by the US Department of Health and Human Services (HHS). Remdesivir is approved for use in outpatient settings as daily intravenous infusion over three consecutive days. As an additional option for patients who are unable to access their health care provider, Test to Treat sites have health clinics at the sites where people can get tested for COVID-19 and evaluated by a health care provider (in person or via telehealth). If vaccination is recommended for you, get vaccinated and stay up to date to protect yourself against COVID-19. Please turn on JavaScript and try again. Back in Maryland, Dr. Vivian Cheung did a lot of sleuthing to get her Evusheld shots. Evusheld consists of two monoclonal antibodies provided together to help prevent infection with the virus that causes COVID-19. Patients who have not received any doses of Evusheld should talk to their health care provider to determine whether, based on their individual circumstances, they are eligible to receive it. 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. HHS/ASPR has partnered with AstraZeneca to establish an additional pathway for providers to access the COVID-19 drug Evusheld for use with eligible patients. Early data suggests it may work less well against the omicron variant of the coronavirus, but it is still expected to offer some protection. . Evusheld is an antibody treatment for immunocompromised individuals to help prevent Covid. Healthcare providers should assess whether treatments are right for their patients.