Key TakeawaysAccording to the Food and Drug Administration (FDA), the monoclonal antibody treatment Evusheld is no longer authorized for use in preventing COVID-19 infections.SARS-CoV-2 has evolved over time. The currently circulating variants of the COVID virus have been resistant to existing monoclonal antibodies.There is currently no other preventive medication for COVID. People at high risk for infection will need to rely on other measures to avoid getting sick.
Key Takeaways
According to the Food and Drug Administration (FDA), the monoclonal antibody treatment Evusheld is no longer authorized for use in preventing COVID-19 infections.SARS-CoV-2 has evolved over time. The currently circulating variants of the COVID virus have been resistant to existing monoclonal antibodies.There is currently no other preventive medication for COVID. People at high risk for infection will need to rely on other measures to avoid getting sick.
Evusheld is no longer authorized for use in the United States. The drug is a monoclonal antibody therapy to help prevent COVID-19 in people who may not have a strong enough immune response to a vaccine.
What Is Evusheld?
Here’s what experts say about the FDA’s decision, why Evusheld is no longer an effective way to prevent COVID, and what you can do if you’re at high risk for catching the virus.
Monoclonal Antibodies Aren’t Working Against New Variants
Monoclonal antibodies are not as effective as they used to be because the structure of the COVID virus has changed a lot.
Michael Angarone, DO, an infectious diseases specialist at Northwestern Medicine, told Verywell that as the Omicron variant and itssubvariantshave evolved, “they have become resistant to the existing monoclonal antibodies.”
Angarone explained that SARS-CoV-2 is changing under the pressure to survive and evolve, just like all viruses and living things.
The virus will change in response to growing protection and defenses developed from natural immunity,vaccine-induced immunity, and monoclonal antibodies. According to Angarone, the proteins the antibodies bind to will mutate and the structure will be different, which causes the antibody to no longer bond or not bond as well.
Evusheld Is Not a Replacement for a COVID Vaccine
No More Preventive Medication for COVID
While Evusheld is no longer approved to be used, the federal government is advising that facilities and providers that currently have doses on hand keep them, as it’s possible that the drug may work againstfuture variantsof the COVID virus.
For the time being, no other monoclonals are authorized for COVID-19, Sullivan said. In fact, the only remaining COVID-19 monoclonal antibody treatment (not preventive) is bebtelovimab, but as of November 22, 2022, it’s no longer authorized for emergency use, either.
Now that there are no authorized or approved agents to prevent COVID, people who can’t get vaccinated or who would not mount a strong response to the vaccine are at even more risk of getting sick.
However, Sullivan said that there are still antivirals that can be used to treat COVID before it progresses to severe disease or requires hospitalization:
As of February 2023, these antivirals are still authorized for use and are expected to work against the currently circulating COVID variants.
FDA Is Considering Annual COVID Vaccines
Other Ways to Prevent COVID
Angarone said that people who cannot get vaccinated or who won’t mount a strong response to a shot “need to be more vigilant about protecting themselves”—for example, staying out of situations that would put them at risk for infection (like large crowds) and avoiding people who are sick.
After Evusheld’s EUA was revised, the Centers for Disease Control and Prevention (CDC) released updated information on COVID prevention for people with immunocompromise and members of their households.
Ifyou are immunocompromised or live with someone who is, here’s what the CDC recommends you do to stay safe:
What This Means For YouEvusheld is no longer authorized to prevent COVID-19. People who are at high risk for infection need to rely on other preventive measures and antiviral treatments to avoid getting sick.
What This Means For You
Evusheld is no longer authorized to prevent COVID-19. People who are at high risk for infection need to rely on other preventive measures and antiviral treatments to avoid getting sick.
COVID-19 Treatments: Medications, Plasma, and Vaccines
The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit ourcoronavirus news page.
4 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.FDA announces Evusheld is not currently authorized for emergency use in the U.S.Food and Drug Administration.FDA announces bebtelovimab is not currently authorized in any U.S. region.Centers for Disease Control and Prevention.COVID-19 treatments and medications.Patel P, Twentyman E, Koumans E, et al.Information for persons who are immunocompromised regarding prevention and treatment of SARS-CoV-2 infection in the context of currently circulating Omicron sublineages — United States, January 2023.MMWR Morb Mortal Wkly Rep. 2023;72(5):128-131. doi:10.15585/mmwr.mm7205e3
4 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.FDA announces Evusheld is not currently authorized for emergency use in the U.S.Food and Drug Administration.FDA announces bebtelovimab is not currently authorized in any U.S. region.Centers for Disease Control and Prevention.COVID-19 treatments and medications.Patel P, Twentyman E, Koumans E, et al.Information for persons who are immunocompromised regarding prevention and treatment of SARS-CoV-2 infection in the context of currently circulating Omicron sublineages — United States, January 2023.MMWR Morb Mortal Wkly Rep. 2023;72(5):128-131. doi:10.15585/mmwr.mm7205e3
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
Food and Drug Administration.FDA announces Evusheld is not currently authorized for emergency use in the U.S.Food and Drug Administration.FDA announces bebtelovimab is not currently authorized in any U.S. region.Centers for Disease Control and Prevention.COVID-19 treatments and medications.Patel P, Twentyman E, Koumans E, et al.Information for persons who are immunocompromised regarding prevention and treatment of SARS-CoV-2 infection in the context of currently circulating Omicron sublineages — United States, January 2023.MMWR Morb Mortal Wkly Rep. 2023;72(5):128-131. doi:10.15585/mmwr.mm7205e3
Food and Drug Administration.FDA announces Evusheld is not currently authorized for emergency use in the U.S.
Food and Drug Administration.FDA announces bebtelovimab is not currently authorized in any U.S. region.
Centers for Disease Control and Prevention.COVID-19 treatments and medications.
Patel P, Twentyman E, Koumans E, et al.Information for persons who are immunocompromised regarding prevention and treatment of SARS-CoV-2 infection in the context of currently circulating Omicron sublineages — United States, January 2023.MMWR Morb Mortal Wkly Rep. 2023;72(5):128-131. doi:10.15585/mmwr.mm7205e3
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