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Hospitals, pharmaceutical companies, and Biden management officials are racing to address one of the Omicron variant’s biggest threats: Two of the three monoclonal antibody treatments that doctors rely on to prevent Covid-19 patients from getting seriously ill don’t seem to be blocking the latest release. your coronavirus.

This type of treatment, which is likely to work against Omicron, is now so scarce that many doctors and hospitals have already run out of supplies.

Monoclonal antibodies have become the mainstay of treatment for Covid, which has been shown to be highly effective in preventing hospitalization of high-risk patients. But even as infections skyrocketed and Omicron became the predominant form of new cases in the United States, some hospitals began shrinking treatments out of fear that treatments would suddenly become useless.

Hospital administrators at NewYork-Presbyterian, NYU Langone, and Mount Sinai in New York have said in recent days that they will stop giving patients the two most commonly used antibody treatments by Eli Lilly and Regeneron, according to notes obtained by The Times and The Times. Officials in healthcare systems.

An infectious disease specialist at Columbia University in New York, Dr. “This is a dramatic change that has occurred over the past few weeks,” said Daniel Griffin. “And I think it makes sense.”

The Omicron variant accounted for an estimated 73 percent of new cases in the United States last week. according to this Centers for Disease Control and Prevention. That’s just over 12 percent the previous week.

(Some researchers They find the rate is not that high yet, although they find that Omicron infections double every two or three days.)

Federal health officials plan to evaluate later this week whether to pause shipments of Eli Lilly and Regeneron products to the states, depending on how dominant Omicron has become in different parts of the country, according to a senior management official speaking on conditional terms. anonymity.

The only monoclonal antibody therapy with good performance against Omicron laboratory experiments at the same time last authorized: sotrovimab was made by GlaxoSmithKline and Vir Biotechnology and was approved in May.

The supply of sotrovimab, which was in high demand even before Omicron appeared, is very limited for now. But the situation is likely to improve somewhat in the coming weeks. The Biden administration is in talks with GlaxoSmithKline about providing more doses early next year, the administration official said.

Regulators are also expected to authorize this week. Antiviral pills from Pfizer and Merck, the first two products in a new class of Covid treatments, according to two senior management officials.

Both pills can prevent serious illness in high-risk patients who may have ever received antibody therapy. Pfizer’s treatment, known as Paxlovid, is particularly promising as it has been found to be extremely effective and possibly work against Omicron.

The supply of these antivirals will be limited initially, but even modest amounts could help ease the burden on doctors who have so far relied on monoclonal antibodies to treat their Covid patients.

Still, the head of the Department of Medicine at the University of California, San Francisco, Dr. Bob Wachter warned that the limited availability of antibody treatments could come as a shock to patients who thought they would be a safe and powerful treatment.

Dr. “If you’ve chosen to be less safe than you might be because of your choice of vaccine or choice of masking, that’s a riskier proposition than it was a few weeks ago,” Wachter said.

Late last year, Regeneron and Eli Lilly received authorization for monoclonal antibody treatments, made by analyzing the blood of people who had recovered from the disease early in the pandemic.

Each patient produced a large number of different antibodies. Companies have focused on one or two that have proven particularly effective in stopping previous versions of the coronavirus.

Clinical trials have shown that these antibodies are effective in preventing hospitalization if given to people in the early stages of their illness. President Trump received Monoclonal antibodies made by Regeneron during its fight against Covid.

At first, doctors struggled to achieve scarce doses. The drugs were typically administered by infusion in hospitals or clinics, and sessions sometimes lasted several hours. Despite the discomfort, monoclonal antibodies are beginning to be widely used in the treatment of Covid.

Some hospitals have set up direct monoclonal antibody clinics, making them more accessible. Doctors have even started giving the drugs only to people who have been exposed to the coronavirus as a way to prevent them from getting sick.

Approximately 68,000 doses of monoclonal antibodies given nationwide last weekAccording to the Department of Health and Human Services. Most patients received treatment with Regeneron, followed by treatment with Eli Lilly.

When variants of the coronavirus began to emerge a year ago, researchers found that some had acquired resistance to monoclonal antibodies. A mutation in surface proteins prevented antibodies from attaching to viruses, a necessary step to neutralize them.

government for several months. paused Nationwide distribution of Eli Lilly’s antibody therapy as it has proven ineffective against variants such as GammaEmerging in Brazil last spring and spreading to many countries.

Fortunately, doctors could still prescribe Regeneron’s treatment, which remains effective against variants and is in ample supply. Since Delta began to dominate this summer, other variants have largely disappeared from the United States.

Delta proved responsive to all permitted antibody treatments. The Biden administration has once again given the green light to Eli Lilly’s treatment, ordering hundreds of thousands of doses.

But Omicron changed everything.

When the new variant was identified in South Africa last month, researchers began lab work testing monoclonal antibodies to see how well they worked against it. The scientists found that both Regeneron and Lilly’s antibodies did an inadequate job of blocking the variant virus from invading cells. Sotrovimab, by contrast, remained potent.

Vir’s CEO, George Scangos, attributed sotrovimab’s durability to the strategy researchers used to find it. Instead of looking at the blood of Covid survivors, the researchers studied the blood of people who survived the 2003 SARS outbreak, which was caused by a related coronavirus.

They detected an antibody that survived SARS and also protects against the coronavirus that causes Covid. This double effect suggested that the sotrovimab antibody attaches itself to a part of the virus that has changed little over the course of its evolution. The researchers thought it would be unlikely to change in new variants.

Dr. “I think we got here not by chance, but through a thoughtful process,” Scangos said.

Clinicians at New York Community Hospital in Brooklyn administer Regeneron and Eli Lilly treatments to approximately 100 Covid patients a day. The hospital’s stock of GSK-Vir treatment ran out a few weeks ago.

The chief medical officer of the hospital, Dr. “If I had a choice, I would give GSK,” said Ralph Madeb.

federal government It has been ordered approximately 450,000 doses of sotrovimab at a cost of approximately $2,100 per person. Shipments began in the fall. But as Omicron emerged, authorities stopped shipments of GSK-Vir’s still-effective sotrovimab to the states in an effort to conserve supply, as scientists determined how threatening the new variant would pose.

When it became clear that Omicron was gaining a foothold, the government allocated 55,000 doses of sotrovimab to the states, and shipments arrived later this week. GSK is expected to deliver an additional 300,000 doses to the US in January.

Dr. “The most important thing is the supply we can have in January, February and March, and we are doing everything we can to increase that,” Scangos said.

GSK spokesperson Kathleen Quinn said the companies are “actively working to expand our capacity”, adding a new manufacturing facility and accelerating their production plans.

Expansion plans may not come early enough for places like the Upper Midwest, which already lacks monoclonal antibodies in the midst of a Covid surge.

The head of the Henry Ford Health System in Michigan, Dr. Bruce Muma said health care and state officials are poised for a cut in Regeneron and Eli Lilly monoclonal antibodies, but are only expecting an insufficient supply of sotrovimab.

Dr. Demand for the treatment has already outstripped supply, Muma said. He waits for frontline staff to encounter angry patients.

“They’re going to be dealing with a frightened population of patients who don’t get what they think they should get,” he said.

Dr. “We can’t afford even the slightest fluctuation and it looks like it will come with Omicron,” Muma said.

Seeing patients in New York, Dr. Griffin said he expects difficult conversations as major healthcare systems stop their use until more effective treatment arrives.

Vaccinated patients should still be in good shape, he said. But those who will be most upset will be patients who “do not want to be vaccinated but think, ‘I can trust Monoclonals’. If I need them, they’ll be there for me.’”

The sudden emergence of Omicron has forced the Food and Drug Administration to quickly figure out how to regulate monoclonal antibodies in this new chapter of the pandemic.

According to agency spokesperson Chanapa Tantibanchachai, the agency is “currently working with sponsors of all authorized therapeutics to assess activity against any global variant of SARS-CoV-2 and is committed to engaging the public as we learn more.” .

An infectious disease specialist at the University of Michigan School of Medicine, Dr. Lindsay Petty said she and her colleagues were at a loss as to when and when to switch to sotrovimab, which is less abundant than monoclonal antibodies.

“We estimate that we will run out of our drug supply every week when we decide to change,” he said.

Both Regeneron and Eli Lilly say they have developed monoclonal antibodies for Omicron, but it will take months before they are ready for use.

Noah Weiland contributed to the reporting.