DRUG MEANT TO PREVENT COVID IS GOING UNUSED

Logistical issues, lack of awareness among obstacles

Sasha Mallett, Sue Taylor and Kimberly Cooley all have immune deficiencies that make them especially vulnerable to COVID-19, and all have tried to get the same thing: a new treatment that can prevent the disease in people who either cannot produce antibodies after receiving a coronavirus vaccine or cannot get vaccinated at all.

Cooley, a liver transplant recipient in Duck Hill, Miss., got the antibody drug, called Evusheld, from her transplant team at the University of Mississippi Medical Center with no trouble. But Taylor, of Cincinnati, was denied the treatment by two hospitals near her home. And Mallett, a physician in Portland, Ore., had to drive five hours to a hospital willing to give her a dose.

As much of the nation unmasks amid plummeting caseloads and fresh hope that the pandemic is fading, the Biden administration has insisted it will continue protecting the more than 7 million Americans with weakened immune systems who remain vulnerable to COVID-19. Evusheld, which was developed by Astrazeneca with financial support from the federal government, is essential to its strategy.

But there is so much confusion about the drug among health care providers that roughly 80 percent of the available doses are sitting unused in warehouses and on pharmacy and hospital shelves — even as patients like Taylor, 67, and Mallett, 38, go to great lengths, often without success, to get them.

Because they have a weakened response to the coronavirus vaccine and may not be able to fight off COVID-19, many immunocompromised people have continued to isolate themselves at home and feel left behind as the country reopens. Evusheld, administered in two consecutive injections, appears to offer long-lasting protection — perhaps for half a year — giving it considerable appeal for this group.

For now, though, the drug is in short supply. Because it is authorized only for emergency use, it is being distributed by the federal government. The Biden administration has purchased 1.7 million doses — enough to fully treat 850,000 people — and had nearly 650,000 doses ready for distribution to the states as of this past week, according to a senior federal health official. But only about 370,000 doses have been ordered by the states, and fewer than one-quarter of those have been used.

Interviews with doctors, patients and government officials suggest the reasons the drug is going unused are varied. Some patients and doctors do not know Evusheld exists. Some do not know where to get it. Government guidelines on who should be prioritized for the drug are scant. In some hospitals and medical centers, supplies are being reserved for patients at the highest risk, such as recent transplant recipients and cancer patients, while doses in other areas of the country are being given out through a lottery or on a first-come, first-served basis.

Hesitance is also an issue. Some doctors and other providers do not know how to use Evusheld and are thus loath to prescribe it. The fact that it is an antibody treatment can be confusing, because most such treatments are used after someone gets COVID-19 rather than for preventive care.

Adding to the confusion are revised Food and Drug Administration guidelines for Evusheld, released last month, that called for doubling the initial recommended dose after data showed the drug may be less effective against certain variants.

Some experts argue that Evusheld should go first to people who cannot get vaccinated because of severe allergies and to those who produce the fewest 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 recommends against using tests that determine antibody levels to assess someone’s immunity.

“The biggest problem is that there is absolutely no guidance or prioritization or any rollout in place at all, and it’s been a mess,” said Dr. Dorry Segev, a transplant surgeon at New York University Langone Health. “Without formal guidelines, you really can’t do anything.”

The Biden administration is trying to address the confusion. Top federal health officials have been working to raise awareness among state health officials, providers and patients. They convened a call this past week with advocates for the disabled to discuss the revised dosing guidance; they also urged patient groups to partner with the administration on outreach and education efforts.