Antibody Drug to Protect the Vulnerable From Covid Goes Unused

Sasha Mallett, Sue Taylor, and Kimberley Cooley have an immunodeficiency

That makes them particularly vulnerable to Covid-19 and they were all trying to get the same thing. A new treatment that could prevent the disease in people who either can’t produce antibodies after receiving a vaccine. Vaccine against coronavirus or cannot be vaccinated at all. Ms. Cooley had a liver transplant in Duck Hill, Mississippi. Received an antibody drug called Evusheld from her transplant team. At the University of Mississippi Medical Center with no problems. But Ms. Taylor of Cincinnati was denied treatment at two hospitals near her home. And Dr. Mallett, a doctor from Portland, Oregon, had to drive five hours to the hospital, ready to give her a dose.

While much of the nation is unmasking amid a sharp decline in cases and renewed hope that the pandemic will fade

The Biden administration insists it will continue to protect the more than seven million immune-compromised Americans. Who remain vulnerable to Covid.. Is essential to AstraZeneca’s strategy. But there is such confusion among health care providers about the drug that roughly 80 percent of available doses sit unused in warehouses, pharmacies. And hospitals — even when patients like Ms. Taylor, 67, and Dr. Mallett, 38, go too much, often unsuccessfully, to get them.

Because they have a weakened response to the coronavirus vaccine and may not be able to fight Covid-19. Many immunocompromised people continue to isolate themselves at home and feel abandoned when the country reopens. Evusheld, given in two consecutive injections, provides long-term protection—perhaps up to six months. Which makes it very attractive to this group. However, the drug is still in short supply. Since it is authorized for emergency use only. It is distributed by the federal government. The Biden administration has procured 1.7 million doses — enough to fully treat 850,000 people — and had almost 650,000 doses ready for state distribution last week. According to a senior federal health official. But only about 370,000 doses were ordered by the states. And less than a quarter of them were used.

“There are so many other people who break and drive for hours to get Evusheld,” said Ms. Cooley, 40, “when it’s on the shelves in Mississippi.”

Interviews with doctors, patients, and government officials show that the reasons for not using the drug vary. Some patients and doctors are not aware of the existence of Evusheld. Some don’t know where to get it. Government guidance on who should be given preference for a drug is sparse. In some hospitals and health centers, supplies are reserved for the highest-risk patients. Such as recent transplant recipients and cancer patients, while in other parts of the country. Doses are distributed through a lottery or on a first-come, first-served basis. – maintainable base.

Indecision is also a problem.

Some doctors and other health care providers do not know. How to use Evusheld and are therefore reluctant to prescribe it. The fact that this is an antibody treatment can be confusing because most of these treatments are used after someone has contracted Covid and not for prevention. Adding to the confusion revised recommendations from the Food and Drug Administration for Evusheld, released last month, which called for a doubling of the initial recommended dose after data showed the drug may be less effective against certain variants.

“It’s stunning and it’s all-new,” said Dr. Mitchell H. Grayson, director of allergy and immunology at the National Children’s Hospital in Columbus, Ohio. “Suppliers are definitely trying to keep up, I just don’t know how well everyone is doing.” Approximately 3 percent of Americans are characterized by medical professionals as immunodeficient because they have a disease that weakens their body’s immune response, or they are receiving a treatment that does. These include transplant recipients and people with conditions such as cancer, lupus, and rheumatoid arthritis.

Evusheld’s arrival in December immediately set off a fight. In Facebook groups and online messages, patients and their loved ones began to share information on how to get it. Evushheld’s government accessibility datasets were so complex and confusing that Seattle-area software developer Rob Relief developed his own cartographic tool which keeps track of how much of the drug is available and which vendors have it.

“People need to know where to go to get in line,” he said.

Relia, 51, had his own interests: his wife, Rebecca, is in remission from cancer. According to him, they unsuccessfully tried to visit 10 hospitals, but thanks to luck they got the medicine since the name of Ms. Reliea was chosen in a lottery for Evusheld in a hospital near their house in early February.

But they haven’t heard anything yet about the second dose that Ms. Reliéa needs based on the new guidelines.

Dr. Mallet from Oregon was one of many who were in desperate need of a cure. She has common variable immunodeficiency, a condition that causes her immune system to not produce enough antibodies. Her son started kindergarten last fall, and when the Omicron virus spiked, his teacher and classmates tested positive for Covid.

When she finally found a hospital in La Grande, Oregon willing to give her a dose, she worked with her doctor to enroll as a patient. Then I dropped everything and went to the hospital in the rain, got injections, and immediately turned back – a total of 11 hours of travel. Dr. Mallett is highly educated, medically savvy, wealthy, and easily distracted from her work—perks that helped her get her to fix, but many others don’t.

“I definitely have a lot of lingering ethical doubts about how I got this drug,” she said. “Did I take advantage of our broken system?”Many of the healthcare workers Dr. Mallett called when she was trying to find a dose had never even heard of Evusheld, even if the medicine was available at their workplace.

Some experts argue that Evusheld should be given primarily to people. Who cannot get vaccinated due to severe allergies and those who develop the least antibodies in response to coronavirus vaccines? But antibodies are only one component of the immune system, and the Centers for Disease Control and Prevention still do not recommend using tests that measure antibody levels to assess someone’s immunity.“The biggest problem is that there is absolutely no guidance, no prioritization or any kind of rollout, and it was a mess,” said Dr. Dorri Segev, a transplant surgeon at NYU Langone Health who is studying coronavirus vaccines in patients after transplants. . “Without formal guidance, you really can’t do anything.”

The Biden administration is trying to clear up the confusion. Top federal health officials are working to raise awareness among state health officials, healthcare providers, and patients. Last week they called a meeting with disability advocates to discuss revised dosage guidelines; they also called on patient groups to work with the administration in outreach activities. “I strongly believe this drug has great potential to help immunocompromised people who do not always respond to vaccines,” said Dr. Rachel Levine, Assistant Secretary of Health for the Department of Health and Human Services. call. But Dr. Levin said she didn’t expect the CDC’s antibody testing guidelines to change.

Patients who cannot be vaccinated are obvious candidates for Evusheld.

But among those who are vaccinated, Dr. Segev and other experts say, the calculations become much more nebulous and may include an assessment of other underlying conditions or risk factors. Experts say that for patients who have managed to get Evusheld, it is still unclear what kind of protection this medicine offers. It is difficult to assess the effect of the drug on protecting immunocompromised patients because many of those recruited for the studies avoided risky behavior and it would be unethical to ask them not to. Researchers may not know the exact effectiveness of a drug for many months.

In clinical trials, Evusheld was found to provide protection comparable to vaccines,

But the number of immunocompromised participants was never disclosed. Adding to the uncertainty, AstraZeneca was studying the drug before Omicron was introduced. Studies over the past few months show that Evusheld protects against variants but it is unclear to what extent.

The lack of reliable information upset Ms. Cooley, a Mississippi liver transplant recipient. She still takes the same precautions she did before getting Evushheld, such as delivering groceries, staying home, and only seeing a few trusted masked family members. This is because she cares for her elderly mother and has seen several other elderly people, including her grandmother, die of Covid-19 in her community, where many people choose not to get vaccinated.

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