Why Supplies of Effective Omicron Treatments Are Scarce

The biggest problem is that the most commonly used Covid antibodies don't work against omicron. 

And the new ones that do appear to work are in short supply as the manufacturers are still ramping up. JL 

Rebecca Robbins and colleagues report in the New York Times:

There is a greater menu of Covid pills now than at any point in the pandemic. The problem is supplies of those that work against Omicron are extremely limited. The two most common antibodies don’t work against Omicron. A third antibody, by GlaxoSmithKline is potent against Omicron. But many have already been used or have not yet been delivered to states. The FDA authorized a new antiviral pill, developed by Pfizer, that shows great promise at fighting Covid in general and Omicron cases in particular (but) supplies are already depleted.

At the onset of the coronavirus pandemic in 2020, scarce ventilators and protective equipment faced strict rationing. Today, as the pandemic rages into its third year, another precious category of products is coming under tight controls: treatments to stave off severe Covid-19.

There is a greater menu of Covid pills and infusions now than at any point in the pandemic. The problem is that the supplies of those that work against the Omicron variant are extremely limited.

That has forced state health officials and doctors nationwide into the fraught position of deciding which patients get potentially lifesaving treatments and which don’t. Some people at high risk of severe Covid are being turned away because they are vaccinated.

Some hospitals have run out of certain drugs; others report having only a few dozen treatment courses on hand. Staffs are dispensing vitamins in lieu of authorized drugs. Others are scrambling to develop algorithms to decide who gets treatments.

“There is simply not enough to meet the needs of everyone who is going to have Covid in the upcoming weeks and be at risk of severe complications,” said Dr. Natasha Bagdasarian, Michigan’s chief medical executive. “I don’t think there is a way to make sure it gets to all the right people right now.”

At Family Health Centers of San Diego, a network of clinics for low-income patients, the staff has had to turn away about 90 percent of the hundreds of people who are calling daily and are eligible for Covid treatments.

“It makes me nauseous going home at night because it makes me feel like I’m deciding, with this limited resource, who should get it,” said Dr. Christian Ramers, an infectious disease specialist there.

A plentiful supply of effective treatments would be a powerful weapon as the virus again surges across the United States. Fueled by the highly contagious Omicron variant, Covid cases have soared to record highs, and the number of hospitalized patients also has increased sharply, though Omicron tends to cause milder illness than other variants.

For most of the pandemic, monoclonal antibodies — a treatment generally administered intravenously at hospitals or clinics — have been the primary option for recently infected patients. But the two most common types of the antibodies don’t appear to work against the Omicron variant, which is quickly becoming the world’s dominant version of the coronavirus.

 

There is a third antibody treatment, made by GlaxoSmithKline and Vir Biotechnology, that is potent against Omicron. But the federal government has ordered only about 450,000 treatment courses, many of which have already been used or have not yet been delivered to states. The Food and Drug Administration two weeks ago authorized the use of a new antiviral pill, developed by Pfizer, that shows great promise at fighting Covid in general and Omicron cases in particular.

The federal government is providing the pill, known as Paxlovid, to states, whose health officials decide where to send the pills and how to advise doctors to use them.

Supplies are already being depleted. New York City, for example, received about 1,300 treatment courses of Paxlovid in late December, which it used up within a week, according to a spokesman for Alto Pharmacy, which is distributing the city’s supply. New York City currently does not have any Paxlovid in stock.

On Tuesday, the U.S. government doubled its order for Paxlovid, though supplies won’t be plentiful until April.

State and local officials say the goal is to get Paxlovid to as many of the most vulnerable people as possible, with a particular focus on those with weakened immune systems or who are unvaccinated.

Unvaccinated people are at far greater risk of hospitalization or death from Covid. But giving them priority access to treatments leaves people feeling “like you are rewarding intransigence,” said Dr. Matthew K. Wynia, the director of the Center for Bioethics and Humanities at the University of Colorado, who has advised the state on how to ration Covid treatments.

Only some states, like Ohio and Nevada, have sent Paxlovid to pharmacies that serve nursing homes, whose residents are especially vulnerable to Covid. Many states, including Virginia, Pennsylvania and Arizona, have sent most or all of their initial Paxlovid supplies to pharmacy chains like Walgreens and Rite Aid.

That was meant to make the pills as widely accessible as possible. But the system rewards patients who have the time, energy and savvy to chase down treatments.

Patrick Creighton, 48, a sports radio host in Katy, Texas, woke up on New Year’s Eve with his throat burning. He was vaccinated but tested positive later that day. Concerned that his diabetes elevated his risk of becoming seriously ill, he decided to seek out Paxlovid, which he had been reading up on.

A telemedicine doctor wrote him a prescription the next day. Now he needed to find a pharmacy with Paxlovid in stock. He said he called 18 pharmacies within driving distance: one Brookshire Brothers, four Krogers, four H-E-Bs, three Walgreens, three CVS stores and three Walmarts. None had the pills.

 

His 19th call was a winner: A nearby Walmart had Paxlovid in stock. The ordeal still wasn’t over. He was incorrectly told that he might have to pay $500 for the free treatment. Then he had to see a second telemedicine doctor because of a problem with the way his prescription was sent. Then his wife had to make a second trip to Walmart to pick up the pills. But on the evening of Jan. 2, he finally took the first three tablets of the 30-pill regimen.

Mr. Creighton said he worried about patients who weren’t able to navigate the obstacles like he could. “It should be easily obtainable for everybody.”

The GlaxoSmithKline antibody treatment is similarly hard to come by.

At the University of Pittsburgh Medical Center, the staff is now giving out 400 to 800 antibody treatments each week, down from 2,000 to 3,000 before Omicron rendered two of the products useless. Demand has rocketed higher, but the hospital no longer has enough supply.

“It is devastating to tell these patients, ‘Sorry, we can’t do anything for you, we have to save this drug only for our most severely immunocompromised,’” said Erin McCreary, an infectious diseases pharmacist at the hospital.

Louis Shantzek, a Miami retiree, tried unsuccessfully to get an antibody infusion last week after he tested positive for the virus. He is 72 and has diabetes and a heart condition — all factors that would normally make him eligible to get an antibody treatment.

Mr. Shantzek’s symptoms included aches, fatigue and a bad cough. When his adult daughter called two nearby hospitals, she was told he couldn’t get an antibody infusion because he had received three doses of a vaccine and was therefore considered at relatively low risk.

“It’s like being told, ‘You’re doing everything you’re supposed to do, but yet we’re not going to help you,’” said Mr. Shantzek, whose symptoms have since eased. This is not the first time in the pandemic that scarce supplies have forced hospitals and doctors into painful treatment decisions. Early on, an intravenous treatment, remdesivir, became so popular that hospitals had to restrict its use. Supplies of remdesivir have since become more plentiful, but the treatment is primarily used for patients who are already hospitalized with severe Covid.

Drug makers say they are working as fast as possible to produce more treatments.

The federal government did not immediately order supplies of the GlaxoSmithKline antibody when the F.D.A. authorized the treatment’s use last May. At the time, the country had an ample supply of other antibody treatments.

In the fall, the Biden administration ordered about 450,000 doses — the maximum amount that Glaxo could provide since the British company had already committed to fulfill orders from other buyers. (The U.S. government has said it plans to buy a further 600,000 treatment courses.)

Pfizer, meanwhile, developed Paxlovid in less than two years. But it takes up to eight months to produce the pills. Though Pfizer started manufacturing them before it began a major clinical trial of the drug last summer, large quantities are only now starting to become available.

An increasing number of hospitals are imposing restrictions on treatments.

In western Indiana, officials at Sullivan County Community Hospital determined last month that they had to restrict eligibility for antibody infusions, after weeks of receiving far fewer doses than they had ordered. They opted to almost entirely exclude vaccinated people.

“It does make it difficult to have some of those restrictions in place, when maybe it’s your family member that doesn’t meet the requirement, or it’s your neighbor, or your child’s teacher at school,” said Lori Resler, the hospital’s chief nursing officer.

In Texas, doctors and their staff have been calling a long list of pharmacies to see who has Paxlovid in stock before prescribing the treatment, said Dr. Luis Ostrosky, chief of infectious diseases at the University of Texas health system. The idea is to avoid sending patients on a wild-goose chase, since many pharmacies received only 20 Paxlovid treatment courses.

Ms. Rizzo said her clinic had not received any antibody treatments since Dec. 24, and it isn’t among the hospitals that were initially picked to receive supplies of Paxlovid. She said clinic employees resorted to providing vitamins and over-the-counter medicines.

Dr. Shireesha Dhanireddy, an infectious disease specialist at the University of Washington, said she spent last weekend poring over the charts of Covid patients to figure out who should get scarce treatments. The three-hospital system has tens of thousands of patients but only 60 courses of Paxlovid. Those getting the pills include patients on certain types of chemotherapy and those who recently received organ transplants.

At Johns Hopkins University, employees are rushing to develop algorithms to help allocate scarce treatments, said Dr. Kelly Gebo, an infectious diseases and epidemiology specialist. Compounding the scarcity problem, workers are falling ill, making it harder to deliver resource-intensive treatments like monoclonal antibodies.

“It’s demoralizing as health care workers when we can’t deliver optimal care when we have limited resources,” she said