Evusheld

Evusheld is not currently authorized for emergency use in the U.S. because it is unlikely to be active against more than 90% of the SARS-CoV-2 variants currently circulating in the U.S. The latest CDC NOWCAST estimate shows that these variants are causing more than 90% of the cases today.

This FDA action follows several previous announcements and guidance updates for Evusheld by federal agencies over the past few months, including:

• At the beginning of October, FDA informed health care providers and individuals taking Evusheld of its loss of activity against some Omicron variants and the increased risk of breakthrough infections, especially as resistant variants became more prevalent as they are today.
• On December 20, the Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Update to supplement the CDC HAN Health Advisories issued on April 25, 2022 and May 24, 2022 to emphasize to healthcare providers, public health departments, and reduced susceptibility to Evusheld.
• On January 6, 2023 FDA released additional communication stating that they were closely monitoring the emergence of the XBB.1.5 subvariant, a SARS-CoV-2 Omicron variant that is currently increasing in prevalence 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.
• On January 10, 2023, NIH’s COVID-19 Treatment Guidelines Panel released a statement indicating that the prevalence of SARS-CoV-2 subvariants likely to be resistant to Evusheld was increasing.

There are several treatments available for COVID-19 infections. Currently available data supports their use in reducing the risk of progression to severe disease, including hospitalization and death. Paxlovid (nirmatrelvir/ritonavir) and Veklury (remdesivir) are the medicines recommended for most people. If those medicines are not available or someone cannot take them, Lagevrio (molnupiravir) is the next choice. COVID-19 convalescent plasma may be another option for certain immunocompromised patients.

If you have signs or symptoms of COVID-19, contact your doctor right away to find out if you should start one of these treatments. 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.

More specifically:

• Paxlovid is authorized to treat mild-to-moderate COVID-19 in adults and children 12 years of age and older weighing at least 40 kg, (approximately 88 lbs.) and who are at high risk of developing severe COVID-19 leading to hospitalization or death.
• Veklury is approved to treat adults and children 28 days of age and older and weighing at least 3 kg (approximately 6.6 lbs.) who have mild-to-moderate COVID-19 and are at high risk of developing severe COVID-19 leading to hospitalization or death.
• Lagevrio is authorized to treat mild-to-moderate COVID-19 in adults who are at high risk of developing severe COVID-19 leading to hospitalization or death, and who do not have access to alternative COVID-19 treatments that are approved or authorized by FDA or for whom these treatments are not clinically appropriate.
• COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies is authorized to treat COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment in in-patient or out-patient settings.

Over the past year, HHS has dramatically increased access to Paxlovid and Lagevrio, both of which are pills. Supplies of these medicines are now widely available at pharmacies, Test to Treat pharmacies, long-term care facilities, and other locations.

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.

HHS, state and local health departments, and other healthcare partners also continue to work to ensure access to COVID-19 vaccines, including the updated (bivalent) vaccine.

Yes: people for whom COVID-19 vaccination is recommended, including people who are immunocompromised, should get and stay up to date with vaccinations. This means getting the updated (bivalent) vaccine, no matter how many boosters you received before the bivalent vaccine became available in September 2022.

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. We will provide further updates and consider additional action as new information becomes available.

Several approved or authorized treatments are expected to remain active to fight against the currently circulating variants and are widely available.

The FDA has worked around the clock throughout the pandemic and used the best available data to ensure options are available to prevent and treat COVID-19. 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.

Disease experts at HHS continually watch for new variants of any viruses and continue to monitor the potential impact that new variants might have on existing therapies. By taking this approach, we can identify the need for new medical products and ways to expedite development of new medical products to address emerging variants. For example, nearly two years ago, the FDA provided guidance to industry on how to efficiently generate non-clinical and chemistry, manufacturing and controls data that could potentially support an Emergency Use Authorization for monoclonal antibody products that had potential to be effective against emerging variants.

In December 2022, FDA and European Medicines Agency (EMA) convened a workshop to bring together the expertise of academics, clinicians, industry, and regulatory bodies to address the acceptability and challenges of alternative strategies to support the development of novel monoclonal antibody therapies including those based on prototype products that have demonstrated safety and efficacy in clinical trials. 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.