Biden’s hospitals, drug companies and government officials are rushing to address one of the biggest threats posed by the Omicron variant: two of the three monoclonal antibody treatments doctors have depended on to prevent Covid-19 patients from becoming seriously ill, don’t seem to thwart the latest version of the coronavirus.
The only treatment likely to work against Omicron is now so scarce that many doctors and hospitals have already used up their supplies.
Monoclonal antibodies have become a mainstay of Covid treatment, which have been shown to be highly effective at preventing high-risk patients from being hospitalized. But even as infections rise and Omicron becomes the dominant form of new cases in the United States, some hospitals have begun to scale back on treatments, fearing they may have suddenly become useless.
In New York, hospital administrators from NewYork-Presbyterian, NYU Langone and Mount Sinai all said in recent days they would stop giving patients the two most commonly used antibody treatments, made by Eli Lilly and Regeneron, according to memos obtained by The Times and officials from the health systems.
“This is a dramatic change in the past week or so,” says Dr. Daniel Griffin, an infectious disease specialist at Columbia University in New York. “And I think it makes sense.”
According to the Centers for Disease Control and Prevention, the Omicron variant was responsible for an estimated 73 percent of new cases in the United States last week. That’s an increase of just over 12 percent the week before.
(some researchers guess the percentage isn’t that high yet, although they also find that Omicron infections double every two or three days.)
Federal health officials plan to assess by the end of this week whether to suspend shipments of the Eli Lilly and Regeneron products to individual states, based on how dominant Omicron is becoming in different regions of the country, according to a senior government official who spoke. on condition of anonymity.
The only monoclonal antibody treatment that has performed well against Omicron in lab experiments is also the most recently approved: sotrovimab, made by GlaxoSmithKline and Vir Biotechnology and approved in May.
It was already in high demand even before Omicron came into existence, sotrovimab supply is very limited for the time being. But the situation is likely to improve slightly in the coming weeks. Biden’s administration is in talks with GlaxoSmithKline about securing more doses to be delivered early next year, the administration official said.
Regulators are also expected this week to approve Pfizer and Merck antiviral pills, the first two products in a new class of Covid treatments, according to two senior government officials.
Both pills can prevent serious illness in high-risk patients who may have received antibody treatments to date. Pfizer’s treatment, known as Paxlovid, is especially promising, as it has been shown to be highly effective — and likely to work against Omicron.
The supply of these antivirals will be limited at first, but even modest amounts could ease the pressure on doctors who until now have relied on monoclonal antibodies to treat Covid patients.
Still, Dr. Bob Wachter, chair of the Department of Medicine at the University of California, San Francisco, said limited availability of antibody treatments could come as a shock to patients who assumed they would be a reliable, potent treatment.
“If you’ve chosen to be less safe than you could be, either because of your choice of vaccines or your choice of masking, it’s a riskier proposition than it was a few weeks ago,” said Dr. watchman.
Late last year, Regeneron and Eli Lilly received authorizations for treatments using monoclonal antibodies 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. The companies focused on one or two that proved particularly powerful in stopping previous versions of the coronavirus.
Clinical trials showed that these antibodies were effective at preventing hospitalization when given to people early in the course of their illness. President Trump received monoclonal antibodies made by Regeneron during his fight with Covid.
At first, doctors struggled to obtain scarce doses. The drugs were usually given as infusions in hospitals or clinics, with sessions sometimes lasting several hours. Despite the inconvenience, monoclonal antibodies have been widely used to treat Covid.
Some hospitals made them more accessible by setting up drive-through clinics for monoclonal antibodies. Doctors even started giving the drugs to people who had only been exposed to the coronavirus to prevent them from getting sick.
Nearly 68,000 doses of monoclonal antibodies were administered across the country last week, according to the Department of Health and Human Services. Most patients received Regeneron’s treatment, followed by Eli Lilly’s.
When the coronavirus variants started popping up a year ago, researchers found that some had become resistant to monoclonal antibodies. A mutation in their surface proteins prevented the antibodies from sticking to the viruses, a necessary step to neutralize them.
For several months, the government has paused distribution of Eli Lilly’s antibody treatment across the country because it proved ineffective against variants like Gamma, which emerged in Brazil and spread to many countries last spring.
Fortunately, doctors were still able to dispense Regeneron’s treatment, which remained effective against the variants and was plentiful. Other variants largely disappeared from the United States when Delta dominated this summer.
Delta was found to be susceptible to all authorized antibody treatments. The Biden administration once again gave the green light to Eli Lilly’s treatment and ordered hundreds of thousands of doses.
But Omicron has changed everything.
When the new variant was identified in southern Africa last month, researchers began lab studies testing monoclonal antibodies to see how well they worked against it. Scientists found that both Regeneron and Lilly’s antibodies didn’t do a good job of blocking the variant virus from invading cells. Sotrovimab, on the other hand, remained potent.
Vir’s CEO George Scangos attributed sotrovimab’s resilience to the strategy researchers used to find it. Rather than looking into the blood of Covid survivors, researchers examined the blood of people who survived the 2003 SARS epidemic caused by a related coronavirus.
They identified an antibody from a SARS survivor that also protected against the coronavirus that caused Covid. That double action suggested that the sotrovimab antibody attaches itself to a part of the virus that has changed very little over the course of its evolution. And in new variants, it probably won’t change, the researchers reasoned.
“I don’t think we got here by luck, but through a thoughtful process,” said Dr. scangos.
At New York Community Hospital in Brooklyn, clinicians have daily administered the Regeneron and Eli Lilly treatments to approximately 100 Covid patients. The hospital ran out of stock of the GSK-Vir treatment a few weeks ago.
“If I had the choice, I’d give GSK,” said Dr Ralph Madeb, the hospital’s co-chief medical officer.
The federal government ordered about 450,000 doses of sotrovimab, at a cost of about $2,100 per person. Shipments started in the fall. But when Omicron showed up, officials halted shipments of GSK-Vir’s still-effective sotrovimab to the states, in an effort to conserve the stock as scientists determined how great the threat posed by the new variant would be.
When it became clear that Omicron was gaining a foothold, the government assigned 55,000 doses of sotrovimab to states, and the shipments arrived as early as this week. GSK is expected to ship another 300,000 doses to the United States in January.
“The most important thing is the supply that we can have in January and February and March, and we’re doing everything we can to increase that,” said Dr. scangos.
Kathleen Quinn, a spokeswoman for GSK, said the companies are “actively working to expand our capacity,” add a new manufacturing facility and accelerate production plans.
The expansion plans may not come soon enough for places like the upper Midwest, which is already deficient in monoclonal antibodies amid a Covid wave.
dr. Bruce Muma, president of the Henry Ford Health System in Michigan, said health system and state officials are bracing for a cut in the monoclonal antibodies Regeneron and Eli Lilly while anticipating just a meager supply of sotrovimab.
dr. Muma said the demand for the treatment already exceeds the supply. He expects frontline staff to encounter angry patients.
“They’re going to have to deal with an anxious population of patients who can’t get what they think they should get,” he said.
“We can’t afford even the slightest wave of a wave, and with Omicron, that’s kind of like what’s to come,” said Dr. mum.
dr. Griffin, who sees patients in New York City, said he expects tough conversations now that major health systems have shut down its use until more effective treatment arrives.
Vaccinated patients should still do well, he said. But the ones most likely to be upset are patients who “didn’t want to be vaccinated but thought, ‘I can trust the monoclonals. If I need them, they will be there for me.’”
The sudden appearance of Omicron has prompted the Food and Drug Administration to quickly figure out how to regulate monoclonal antibodies in this new chapter of the pandemic.
The agency “is working with sponsors of all currently authorized therapies to assess activity against each SARS-CoV-2 variant(s) worldwide of interest and is committed to communicating with the public as we learn more.” said agency spokeswoman Chanapa Tantibanchachai. .
dr. Lindsay Petty, an infectious disease specialist at the University of Michigan School of Medicine, said she and her colleagues were concerned about when and whether to switch from the abundant monoclonal antibodies to the scarcer sotrovimab.
“Once we decide to change, we expect to run out of drugs every week,” she said.
Both Regeneron and Eli Lilly say they are developing monoclonal antibodies for Omicron, but it will be months before they are ready for use.
Noah Weiland contributed coverage.