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Just one monoclonal antibody drug works against omicron

Just one monoclonal antibody drug works against omicron It’s in short supply at New Jersy hospitals. New Jersey hospitals have tightened access to COVID-19 monoclonal antibody treatments after the two previously leading therapies failed to work against the omicron variant and a newer, more effective treatment is in short supply, health officials say.

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Sotrovimab, made by GlaxoSmithKline and Vir Biotechnology, successfully treats omicron and has become the primary — and in many cases, sole — monoclonal antibody therapy given to coronavirus patients.

But it is hard to find in New Jersey and around the nation.

Omicron, which first emerged in November in Botswana and South Africa, has proven largely resistant to antibody treatments by Regeneron and Eli Lilly that thwarted the impact of previous variants, including delta. That has alarmed health care providers, who say omicron now accounts for more than 75% of their COVID-19 cases.

That has forced hospitals such as Holy Name in Teaneck to further restrict access to monoclonal antibody therapy, limiting the treatment to the most vulnerable people in high-risk groups who come in within the first few days of the onset of mild to moderate symptoms.

“We’ve decided we’re going to give it to these people only,” said Dr. Benjamin De La Rosa, an infectious disease specialist at Holy Name. He added, “When the supply becomes more available, we will open it up to other people in the community.”

Restricted access to the treatment affects not just people with COVID-19, but the entire health system, which is seeing soaring numbers of coronavirus patients and serious staff shortages. New Jersey set yet another record Wednesday in reporting 31,391 new COVID-19 cases and followed with 27,404 positive tests on Thursday.

Nearly 5,600 residents statewide are hospitalized with the coronavirus, the most since May 1, 2020.

Monoclonal antibody treatments have played a crucial role, health officials say, in helping those with COVID-19 avoid hospitalization and death.

Some hospitals made the therapies available to those who were not in the highest risk categories and as a prophylactic for high-risk people who were not infected, but were exposed to someone who had tested positive.

But with just one option now available to treat omicron, and in limited supply, they have had to narrow eligibility to the most vulnerable.

Two recently approved antiviral pills to treat COVID-19 — Pfizer’s Paxlovid and Merck’s molnupiravir — have been distributed to more than 30 states, including New Jersey. But those too are in limited supply.

“Initially, the N.J. Department of Health has received a limited supply of antiviral pills from the federal government,” Donna Leusner, a spokeswoman for the state Department of Health, said in a statement to NJ Advance Media. “New Jersey has started with centralized dispensing from one pharmacy chain (Walgreens) for the anti-viral pills.”

“As the federal distribution increases, antiviral pills will be provided to additional pharmacies and long-term care facilities,” Leusner added. “Antivirals are only available with a prescription to those who meet [federal] requirements.”

Holy Name was administering about 25 to 30 monoclonal antibody treatments daily when the delta variant was the dominant strain. Now that omicron is dominant, the hospital is relying on just sotrovimab, scaling back treatments to between five and 10 a day, De La Rosa said.

On Dec. 23, Holy Name officially announced to its staff that only sotrovimab would be used for COVID-19 patients, De La Rosa said. It had become obvious that Regeneron, the main antibody treatment Holy Name had been using — with significant success — since December 2020, was not working nearly as well after Thanksgiving, he said.

“When people received these monoclonal antibodies, after, even the next day, they said they felt amazing, they said they felt great,” he said, referring to the impact of the therapy before omicron. “They were very effective treatments that allowed people to stay home to recover.”

In fact, Regeneron and Eli Lilly’s antibody treatments were the top therapies used for people with mild to moderate COVID-19 symptoms through the beginning of November. Typically administered through an IV at hospitals or other facilities with infusion sites, the treatments proved successful at helping coronavirus patients avoid severe illness.

But then the treatments began to have markedly less impact and, in some cases, produced side effects, De La Rosa said.

“People who were receiving this treatment were either having reactions to the monoclonal infusion or not getting better, were feeling crummy. They were ill after getting the infusion,” he said. “Now more and more people were getting the infusion and having side effects or ending up in the hospital.”

But sotrovimab is effective against the omicron variant, despite its numerous mutations, De La Rosa said.

“The issue now is that it’s in extremely limited supply,” he noted.

The hospital, like many others, is giving the therapy to people who come in within the first few days of the onset of mild to moderate COVID-19 symptoms and are in the most vulnerable of high-risk groups, such as those older than 65 who have a body mass index of 35 or more, diabetes that is not well-controlled, unvaccinated pregnant women and people with compromised immune systems.

Federal health officials in December briefly paused shipments of Regeneron and Eli Lilly antibody drugs to states, saying, “Omicron may be associated with resistance to mononclonal antibodies.”

The announcement cited the reduced effectiveness of both antibody treatments against omicron, and added that data indicated that “sotrovimab appears to retain activity against the omicron variant.”

Federal officials resumed shipping Regeneron and Eli Lilly, however, given that the delta variant is still present. Sotrovimab also appears to be highly effective at thwarting delta and other variants, health officials say.

For the week of Jan. 3-9, the U.S. Department of Health and Human Services reported nearly 200,000 shipments of monoclonal antibody drugs. Almost 50,000 were sotrovimab. New Jersey received 9,286 monoclonal antibody therapeutics — 2,544 of them were sotrovimab, the sixth-highest amount sent to any state, according to the HHS website.

The Biden administration has been working with GlaxoSmithKline to get more doses, according to published reports.

RWJBarnabas Health is offering sotrovimab to only the most vulnerable COVID patients, spokeswoman Carrie Cristello said in a statement.

“Due to very limited supply, utilization of monoclonal antibody therapy for COVID-19 is being prioritized for patients with the highest risk for progression to severe COVID-19, including hospitalization or death, who are 65 years of age or older or have a congenital or acquired immunodeficiency, hematologic malignancies, solid tumors or are solid organ transplant recipients,” she said. “Due to the prevalence of the omicron, only sotrovimab monoclonal antibody therapy is being administered at this time.”

Some health officials describe the simultaneous surge in omicron infections and the ineffectiveness of monoclonal antibody treatments they had come to rely on as a double gut-punch.

“It is a disappointment,” said Dr. Jack Audett, the chief medical officer at Overlook Medical Center in Summit, part of Atlantic Health System. “We really saw a demonstration of efficacy in terms of a sharp decrease of deaths.

“We’re looking at a more scarce resource, so the rationale is to be a little more exclusive in terms of how to use that very scarce resource. So for several weeks, we’ve really been cutting down on the population in terms of who is eligible … less than 65 years old we’re really not doing at this point — age seems to be a major determinant of who’s going to do poorly” if they contract COVID.

Timothy Lise, the executive director of pharmacy services for Atlantic Health System, said they have been able to keep enough monoclonal antibody drugs on hand to administer about 20 to 30 infusions daily.

“We’ve been maintaining our volume,” he said. “We’re trying to decrease mortality and trying to keep these patients from coming to the hospitals.”

Virtua Health switched over to sotrovimab about two weeks ago, said Dr. Martin Toile, the infection control officer and head of infectious diseases for the hospital system.

“Because of the lower supplies available, we further prioritized what we can offer until there’s a better window into how many doses will be available to us from the state,” Toile said. “It’s all new. It’s not clear what volume of dosing will be available [from the federal government] to each state.”

The surge of omicron, although it seems to produce milder symptoms than previous variants, nonetheless had led to an influx of hospital patients not seen since the earliest days of the pandemic. That has left many acute-care facilities with less resources and time to figure out which coronavirus variant they are dealing with and how to address it.

“That’s what makes it very challenging,” Toile said. “We had difficulty because we don’t really have the means to really identify individual patients [to know] which variants they may have, so we don’t have the capability of saying, ‘Use this drug vs. another drug’ for each individual patient.”

Prior to omicron, he said, Virtua had the time and resources to follow up on the outcome of patients who had received monoclonal antibody treatments. But since infection and hospitalization rates started soaring, they have been unable to track outpatient results as closely.

“Now we’re in more of a crisis mode,” said Toil, adding that “at least 85% percent of our cases are omicron. It’s probably much higher than that.” “We don’t have the ancillary personnel. They’re being utilized for other purposes. We try to keep track of it. But I haven’t heard of any hospitalizations in people who have received the [monoclonal] drug as an outpatient.”

Monoclonal antibodies were largely on the margins of public awareness until the fall of 2020, when then-President Donald Trump contracted the coronavirus and received an infusion of Regeneron’s therapy before the FDA authorized emergency use. Trump credited it with helping him recover. Weeks later, then-Housing and Urban Development Secretary Ben Carson, who tested positive for COVID-19, said the drug “saved my life.” Former Gov. Chris Christie also received the treatment in 2020 when he contracted the coronavirus.

Hospital officials expressed hope that the antiviral pills, which received federal emergency use authorization late last year, will help in keeping high-risk people from getting severely ill and requiring hospitalization. Both have proven effective against omicron.

But officials told NJ Advance Media that they are not yet familiar with how access will work, and how much of a supply there will be.

“We’re excited about the oral antivirals,” said Lise, the pharmacy services executive director for Atlantic Health System. “Patients can get access to therapy where monoclonal antibodies treatment would not be viable.”

Lise said he hopes the state eventually distributes the antiviral pills to other pharmacies, including those that are part of hospital systems. Given the tight time frame — a few days — in which a pill must be given in order to work after the onset of symptoms, being able to provide the drug to newly diagnosed patients would be crucial, he said.

“Store locations are prioritized based on rapid and drive-thru testing capabilities, high levels of COVID-19 within the community, vaccination rates and accessibility for high risk, socially vulnerable populations,” Walgreens spokesman Alex Brown said in a statement to NJ Advance Media. “Initially, COVID-19 oral antiviral inventory is limited and allocation will continue to increase over time as inventory builds.”

The pills must be prescribed by a health care provider as soon as possible after a COVID-19 diagnosis and within five days of reported symptoms, according to the statement. Citing the FDA and Centers for Disease Control and Prevention, Walgreens said eligibility for Paxlovid is limited to “adults and pediatric patients 12 years of age and older weighing at least 88 pounds with positive results of a COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death.”

Molnupiravir is limited to “adults ages 18 and up with positive results a COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.”

A South Jersey motorist died Thursday morning following a two-vehicle crash in Gloucester County, officials said.

The 76-year-old Williamstown woman was driving an SUV east on Grandview Avenue approaching the Black Horse Pike/Route 42 in Monroe Township around 6 a.m., when she tried to make a left turn to enter the northbound lanes of Route 42, according to township police.

In doing so, police said she failed to yield to an SUV headed south on Route 42, which struck the driver’s side of her vehicle.

The woman was pronounced dead at the scene, police said.

The 38-year-old Pleasantville man driving the other vehicle was taken by ambulance to Cooper University Hospital, Camden, for treatment of arm and facial injuries, police said.

For at least the third time this week, winter weather is causing school closures or schedule changes. This time, most of New Jersey can expect to see about 2 to 4 inches of snow on Friday.

Light snow is expected to arrive late Thursday night to around midnight then intensify before 7 a.m. making for a messy commute, forecasters predict. Parts of South Jersey already experienced snow on Monday, and many roads in the state were iced over on Wednesday from freezing rain, causing accidents and school delays.

For Friday, many schools are announcing snow days or other schedule changes in light of the storm. Hundreds of school districts throughout the state already temporarily switched to virtual learning due to a record-breaking spike in COVID cases.

However, state law prohibits schools from having a single virtual day due to the weather and have it count toward the 180 days of school required by law.

Robert Menendez Jr., son of U.S. Sen. Robert Menendez, announced his candidacy for Congress Thursday to succeed retiring Rep. Albio Sires.

Menendez, a lawyer and Port Authority commissioner, made the announcement on the first anniversary of the Jan. 6 insurrection.

“The assault on the Capitol was about a part of our country unwilling to accept that our nation is changing and holding on to a past that has left too many behind,” Menendez said.

“One year later, it has become evident that our challenges can’t wait. Whether it’s dealing with the impact of the pandemic on our children’s future, the ability of individuals to get back to work, or getting serious about protecting each individual’s right to vote, we have no time to waste.”

Menendez already has sewn up endorsements from Gov. Phil Murphy, U.S. Sen. Cory Booker, and Hudson County state and local officials.

The state’s independent redistricting commission preserved a Hispanic majority in the Hudson County-centered 8th District, which Sires currently represents, and it is considered a safe Democratic district.

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