A medication is available to prevent COVID in people with compromised immune systems but many of those eligible in New Jersey don’t know about it and haven’t received it.
The medication, Evusheld, received emergency use authorization from the federal Food and Drug Administration in December.
At first, supplies were limited and doctors worried they would be forced to make difficult ethical decisions if demand outstripped supply. In Florida, reports surfaced of Evusheld “tourists” who traveled there after being denied the treatment in their home states.
But in New Jersey, supplies have been readily available since late January. The state has received 30,696 courses of the treatment — given as two injections, one right after the other — and 2,456 were available at 58 sites as of Tuesday.
“There was a real concern about supply, but that has not materialized,” said Dr. Thomas Bader, chief clinical officer and senior vice president for Hackensack Meridian Health, which developed ethical guidelines to prepare for allocating the treatment. “We’re a little disturbed that it hasn’t materialized, frankly. If you look at all the people who might benefit, they haven’t been found yet.”
Hackensack Meridian has administered Evusheld to about 350 patients at its hospitals, he said. The U.S. government buys supplies from AstraZeneca, the manufacturer, and distributes them at no charge to providers and some pharmacies.
“There are plenty of patients who slip through the cracks,” said Dr. Ronald Nahass, president of ID Care, the state’s largest infectious disease practice. Its doctors have given Evusheld “liberally” to those who meet the FDA’s guidelines, he said.
Nevertheless, “a host of individuals who may be good candidates are not being identified,” he added. “The level of awareness in the provider community is not high enough.”
Researchers estimate about 2.7% of the U.S. population is immune compromised. In New Jersey, that’s about 250,000 people. Based on those estimates, under current FDA guidelines about who is eligible for Evusheld, only 11% have received it so far.
As social distancing and masking guidelines have been lifted and people return to public gatherings, many people with weakened immune systems are still at risk. They feel left behind as others put the pandemic behind them.
“I am continuing to be extremely careful,” said Susan McTigue, 68, of Closter, who has been in remission from non-Hodgkin lymphoma, a cancer that starts in the white blood cells, following chemotherapy after her diagnosis in 2017. Even after four shots of the Pfizer vaccine — the primary series and two boosters — she said tests showed her body had not produced antibodies to COVID.
“I mask up whenever I’m out,” she said, “especially indoors. I’m washing my hands, doing everything I did before,” during the pandemic’s peak. Sometimes she wants to tell people to “put on your damn mask for my sake,” she said, but “people don’t want to hear that. I don’t say anything.
“I do what I have to do to defend myself,” she added. “I can’t live in a black hole. I have to have a life.” She was eager to get the Evusheld injections when they were offered.
Here’s who’s eligible for Evusheld
Under FDA guidelines, those eligible for Evusheld are people whose immune systems are moderately or severely compromised because of a medical condition or the use of immune-suppressing medication, as well as those who’ve had a severe adverse reaction to the COVID vaccine or are allergic to its ingredients. They must be 12 or older and weigh at least 88 pounds.
That includes organ transplant recipients who take immune-suppressant drugs, people undergoing chemotherapy for blood cancers and solid tumors, people who’ve received stem cell transplants within the past two years, and some patients with rheumatoid arthritis or certain types of multiple sclerosis. Others with diseases or conditions that prevent their body from forming a strong immune response to a vaccine — such as advanced HIV or other syndromes — are also eligible.
But old age or residing in a congregate setting such as a nursing home or psychiatric hospital does not automatically qualify someone for the preventive injections. Although those people are more vulnerable to severe disease if they do get COVID, the most effective prevention for them is vaccination.
Hospital safety grades:Showing COVID’s impact in NJ as Holy Name, St. Joseph’s get low marks
Nor is Evusheld effective to prevent COVID immediately after a known exposure or to treat COVID once symptoms have developed.
McTigue received her injections earlier this year at Hackensack University Medical Center’s John Theurer Cancer Center.
“I went in, they gave me a COVID test, then I got two shots — one in each glute,” she said. “No big deal.” Other than a little pain at the injection sites, she didn’t have any side effects.
How Evusheld prevents COVID
The shots deliver antibodies that circulate in the body, defending it against any incursions by SARS-CoVid-2, the virus that causes COVID. The two injections each contain a different, long-acting monoclonal antibody that blocks the virus’ spike protein from attaching to and entering human cells.
No memory T-cells or B-cells are generated to fight off the coronavirus. “It’s the same way a newborn gets antibodies from the mother’s breast milk,” said Bader, of Hackensack Meridian. “It’s passive antibodies. The cellular branch of the immune system is not activated.”
As a result, the strongest protection from Evusheld occurs immediately after the injection. After that, the antibodies gradually break down. That’s why vaccination is better for those with normal immune systems — the vaccine generates two levels of immunity, via antibodies and the cellular immune system.
The evidence of Evusheld’s effectiveness cited by the FDA for its emergency use authorization comes from a clinical trial of nearly 3,600 unvaccinated people, a third of whom received a placebo.
In the study, Evusheld reduced the rate of infection by 83% during the six and a half months after it was given, with no serious or critical adverse events. The study was conducted before the omicron wave of the coronavirus, and the doses were half the size currently used. (The emergency use authorization was amended in February to increase the dose recommended.)
In actual use, Evusheld appears to be effective against omicron and its subvariants. “So far Evusheld seems to be holding up,” Bader said. “So far, so good.”
While supplies of Evusheld are adequate now, the White House has warned that congressional inaction on its request for more funding to prevent COVID will eventually cause shortages.
“Evusheld is a really nice complement to vaccination and boosting for those that may not generate a strong immune response to vaccines,” Dr. Ashish Jha, the White House Coronavirus Response Coordinator, said earlier this month. While the government has purchased 1.7 million courses of the treatment, he said, it won’t be able to buy more without further funding from Congress.
“As adoption increases and usage increases here, it’s something that is very important,” he added.
Bader still is surprised that the lottery Hackensack Meridian executives thought would be necessary has not been implemented. When the FDA amended its recommendation to double the dose of Evusheld in February, he said, “We thought this is surely going to sink us.”
Extra cautious:Montclair High School reinstitutes mask mandate due to COVID case surge
But it didn’t. On Tuesday, Hackensack Meridian hospitals had 288 courses of the treatment available, according to the government’s COVID Therapeutics Locator, which is publicly available at https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/
However, Bader said, “We still believe that if everybody who benefited from Evusheld got it, there wouldn’t be enough.”
Bergen New Bridge Medical Center’s chief medical officer agreed. “I think a lot of people don’t realize it’s there,” said Dr. Gian Varbaro. “They just don’t know about its existence.”
But they should, he said. “This is the type of medicine you want to have ahead of time, and not wait for the next wave [of the pandemic] coming.”
Lindy Washburn is a senior health care reporter for NorthJersey.com. To keep up-to-date about how changes in health care affect you and your family, please subscribe or activate your digital account today.
Email: [email protected]