Evusheld No Longer Authorized to Prevent COVID
By Carla Delgado
Published on February 08, 2023
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.
On January 26, 2023, The Food and Drug Administration (FDA) revised Evusheld’s Emergency Use Authorization (EUA) because research is showing that the drug is not providing enough protection against the SARS-CoV-2 variants that are circulating. Currently, these variants are responsible for more than 90% of infections in the U.S.1
What Is Evusheld?
Evusheld is a combination of two monoclonal antibodies: tixagevimab and cilgavimab. Monoclonal antibodies bind to a specific site on the COVID virus to prevent it from getting into human cells. The drug was developed by AstraZeneca as pre-exposure prophylaxis for COVID.
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.
Why the FDA Pulled Authorization for the Only COVID Monoclonal Antibody Treatment Left
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 its subvariants have 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.
David Sullivan, MD, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, told Verywell that monoclonal antibodies work by binding to the tip of the spike protein. However, this part of the viral protein is constantly changing to make sure that it can continue to bind to the angiotensin-converting enzyme 2 (ACE2) receptors in human cells.
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 against future variants of 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.2
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:3
Nirmatrelvir with ritonavir (Paxlovid), an oral medication
Remdesivir (Veklury), administered via intravenous (IV) infusion
Molnupiravir (Lagevrio), an oral medication
As of February 2023, these antivirals are still authorized for use and are expected to work against the currently circulating COVID variants.1
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.4
If you are immunocompromised or live with someone who is, here’s what the CDC recommends you do to stay safe:
Stay up-to-date with your COVID vaccinations and boosters
Wear a well-fitting respirator or mask
Maintain distance in crowded spaces
Improve the ventilation in your home by opening windows or using exhaust fans to improve airflow
Practice frequent proper handwashing and use hand sanitizer with more than 60% alcohol
Find testing locations (you can use the CDC’s COVID-19 testing locator to find a place to test near where you live)
Talk to your provider about treatment options before you get sick
Get tested after you’ve been exposed to the virus or if you have symptoms of COVID
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.
https://www.verywellhealth.com/evusheld-no-lo...se-7104142
By Carla Delgado
Published on February 08, 2023
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.
On January 26, 2023, The Food and Drug Administration (FDA) revised Evusheld’s Emergency Use Authorization (EUA) because research is showing that the drug is not providing enough protection against the SARS-CoV-2 variants that are circulating. Currently, these variants are responsible for more than 90% of infections in the U.S.1
What Is Evusheld?
Evusheld is a combination of two monoclonal antibodies: tixagevimab and cilgavimab. Monoclonal antibodies bind to a specific site on the COVID virus to prevent it from getting into human cells. The drug was developed by AstraZeneca as pre-exposure prophylaxis for COVID.
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.
Why the FDA Pulled Authorization for the Only COVID Monoclonal Antibody Treatment Left
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 its subvariants have 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.
David Sullivan, MD, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, told Verywell that monoclonal antibodies work by binding to the tip of the spike protein. However, this part of the viral protein is constantly changing to make sure that it can continue to bind to the angiotensin-converting enzyme 2 (ACE2) receptors in human cells.
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 against future variants of 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.2
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:3
Nirmatrelvir with ritonavir (Paxlovid), an oral medication
Remdesivir (Veklury), administered via intravenous (IV) infusion
Molnupiravir (Lagevrio), an oral medication
As of February 2023, these antivirals are still authorized for use and are expected to work against the currently circulating COVID variants.1
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.4
If you are immunocompromised or live with someone who is, here’s what the CDC recommends you do to stay safe:
Stay up-to-date with your COVID vaccinations and boosters
Wear a well-fitting respirator or mask
Maintain distance in crowded spaces
Improve the ventilation in your home by opening windows or using exhaust fans to improve airflow
Practice frequent proper handwashing and use hand sanitizer with more than 60% alcohol
Find testing locations (you can use the CDC’s COVID-19 testing locator to find a place to test near where you live)
Talk to your provider about treatment options before you get sick
Get tested after you’ve been exposed to the virus or if you have symptoms of COVID
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.
https://www.verywellhealth.com/evusheld-no-lo...se-7104142
