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A monoclonal antibody treatment made by GlaxoSmithKline and Vir is no longer licensed to treat COVID-19 in the US because it does not work against the omicron subvariant, BA.2, the US Food and Drug Administration said Tuesday. USA
it is now responsible for more than 70% of COVID-19 cases in the United States, data from the US Centers for Disease Control and Prevention shows, meaning that most people who get sick with COVID-19 will now have the newer form of omicron. In March, GlaxoSmithKline said the FDA found its sotrovimab treatment “unlikely” to be effective against the BA.2 variant. The companies added that they are preparing data on a higher dose of sotrovimab that may work against BA.2.
Sotrovimab, like other monoclonal antibodies, has been used as a treatment for COVID-19 in people who are at higher risk of severe COVID-19 illness or hospitalization in the first few days of their symptoms.
Bebtelovimab, made by Eli Lilly, is a monoclonal antibody still licensed for use in patients 12 years of age and older who have mild or moderate COVID-19 and are at high risk of severe disease. The antibody should be used when other treatments for high-risk patients are unavailable or inappropriate, and should be given within the first seven days of COVID-19 symptoms, the FDA said.
In January, the FDA withdrew emergency use authorization for a previous monoclonal antibody treatment made by Eli Lilly and also one made by Regeneron (REGEN-COV) because they no longer worked to prevent serious illness caused by the virus.. But in the future, the FDA noted, these treatments may be used when someone is likely to be infected or exposed to a variant that the drugs are effective against.
Other treatments still available for patients at risk include, molnupiravir and remdesivir. In January, the FDA expanded the use of remdesivir to treat at-risk patients in the early days of their illness, including children younger than 12 years. Previously, it was authorized only for people hospitalized with COVID-19.
In March, the White House warned that without more COVID-19 funding from Congress, the U.S.it depends on its pandemic response. Although a smaller pandemic package is now being debated in the Senate, with no action, the federal supply of monoclonal antibodies shipped to states will run out by the end of May, according to the Biden administration.
Here’s what you should know about monoclonal antibodies.
What are monoclonal antibodies and how do they work?
Monoclonal antibodies are laboratory-made antibodies that work by attaching to bacteria, cancer cells, or viruses in the same way that natural antibodies do, stopping them from infecting more cells. The first monoclonal antibody therapy was approved more than 30 years ago and has been used for other diseases, including cancer.
Monoclonal antibody treatments for COVID-19 are used before a person becomes seriously ill, usually within seven to 10 days of first showing symptoms, to prevent hospitalization and death. The antibodies are not used in someone who is already hospitalized and receiving treatment with supplemental oxygen, for example.
A monoclonal antibody therapy made by AstraZeneca (Evusheld) isbefore a person is sick or exposed, but only for people who are immunocompromised or who do not develop an adequate immune response to COVID-19 vaccines.
Who is eligible?
Monoclonal antibody treatments, as well as other COVID-19 treatments, are reserved for people at higher risk of severe illness from COVID-19, which includes adults age 65 and older and people living with medical conditions such as diabetes, asthma , obesity and more. Monoclonal antibody treatment is usually given intravenously or by infusion.
Eli Lily’s licensed bebtelovimab antibody is for high-risk patients over 12 years of age with mild or moderate disease, but treatment must be given within seven days of the first symptom. If people have a positive COVID-19 test but did not develop symptoms, they do not meet the criteria for “mild or moderate” illness, according to a fact sheet. It will also be given if other treatments are inaccessible or inappropriate for the patient, the FDA said. The New York Times reported that this is likely because, although data show the antibody is effective against omicron, the drug has not been tested in a study to definitively show that it prevents severe disease.
Why did the FDA stop the use of some monoclonal antibodies?
The virus that causes COVID-19 has mutated over time, reducing the effectiveness of some COVID-19 treatments, including monoclonal antibodies. This is because antibody treatments are laboratory-made proteins that mimic the immune system’s ability to fight viruses, according to the FDA, which must be sufficiently compatible with the current variant or subvariant.
How do I get treatment? It’s free?
The government has agreed to buy COVID-19 treatments as part of its response to the pandemic, including doses of monoclonal antibodies. This means that the drug itself is free, and the administration fee may also be waived, depending on your insurance.
Americans without health insurance, however, may be forced to pay an administrative fee (what it costs someone to treat you) since the Uninsured Program has stopped accepting claims from providers who treat, test or vaccinate Americans. uninsured Americans, citing a “lack of sufficient funds.
If you don’t have health insurance and are looking for monoclonal antibody treatment or another therapy, call the clinic you plan to visit to see if or how much you’ll have to pay. It may depend on the clinic and the state and other resources available locally.
The same funding problem that plagues the uninsured is also poised to disrupt the country’s supply of monoclonal antibodies. Doses may run out as soon as the end of May, the White House said, but a bill currently being discussed in the Senate would replenish some of the country’s pandemic needs. It could also restore options available to people without health insurance.
To find treatment near you, you can call the Combat COVID Monoclonal Antibody Call Center at 1-877-332-6585 or your primary care doctor.
Do monoclonal antibodies interfere with coronavirus vaccines?
If you received treatment with monoclonal antibodies and have not yet been vaccinated, you must wait 90 days after your treatment to get vaccinated, according to the CDC. This recommendation is until more is known about how the antibody response to treatment affects the immune response to vaccination.
Everyone 5 years of age and older is eligible to receive a COVID-19 vaccine in the US.
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health care provider regarding any questions you may have about a medical condition or health goals.