There's a new drug to prevent Covid-19, but there won't be nearly enough for Americans who are eligible
(CNN) -- For Americans who suffer from weak immune systems, it felt like a miracle occurred on December 8. That day, the US Food and Drug Administration authorized a drug to help keep immune-compromised people from getting infected with the coronavirus.
But that joy quickly turned to despair as patients learned the government has only contracted for enough doses for less than one-tenth the number of people who are eligible for it.
The first batch of the drug, called Evusheld, shipped out on Monday, according to a spokesperson for the US Department of Health and Human Services. Dr. Camille Kotton, an infectious disease expert at Mass General Brigham, said her medical system expects to receive in this shipment only doses to treat fewer than 1% of its thousands of immune-compromised patients.
The Covid-19 vaccines worked well for many -- but not all -- people with suppressed immune systems, leaving them vulnerable to the virus. Evusheld is a monoclonal antibody, and doctors hoped to give it to their immune-compromised patients because it works in a different way than the vaccines.
"I am very concerned about the immune-compromised population," Kotton said. "I'm disappointed we don't have better access, and I hope we have better access very soon so we can prevent as much illness and potentially death in this population as possible."
"It's a shame that something that really could be a game changer for people who didn't have a good vaccine response is now going to be something that is in short supply," said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University and a leading researcher on vaccine effectiveness for people who are immune-compromised.
In a clinical trial with more than 5,000 participants, those who received Evusheld -- which is given in two shots one right after the other -- saw a 77% reduced risk of developing Covid-19 compared to those who received a placebo, according to the FDA.
Four percent of the people in the trial were immune-compromised, according to a company spokesperson, but their results have not been published separately.
CNN interviewed more than two dozen Americans whose suppressed immune systems kept them from getting full protection from Covid-19 vaccines.
"I cried tears of joy when I read the headline about Evusheld. Finally, we had hope, and then to have it dashed -- well, the reality is sinking in," said Diane Barron, 51.
Barron has lymphoma and rheumatoid arthritis, and her immune system is weak. Blood tests show even after three doses of Pfizer's vaccine, she has no detectable antibodies against Covid-19. At high risk of dying from the virus, Barron remains a virtual prisoner in her home in Fort Lauderdale, Florida.
So do many other people with compromised immune systems -- many transplant recipients, for example, or certain patients with cancers or autoimmune diseases.
About 7 million adults in the US are immune-compromised and could benefit from Evusheld, according to its manufacturer, AstraZeneca. The federal government, which is the sole distributor of the drug, has contracted for only enough doses to treat 700,000 people.
The 7 million figure comes from US Centers for Disease Control and Prevention information about vaccines and the immune-compromised. The drug is also available to immune-compromised adolescents ages 12-17.
AstraZeneca does have more doses available for purchase, a company spokesperson told CNN.
"The US government could purchase more doses if they wanted to," the company spokesperson wrote in an email. "We already hold inventory of finished product that exceeds near-term forecast demand, and manufacturing capacity has been reserved with significant further quantities of product already in various stages of manufacture in the supply chain."
One health official told CNN the government "is preparing to purchase significantly more Evusheld" than the 700,000 doses.
That official, and some others contacted by CNN, asked to speak anonymously in order to candidly discuss preparations and planning.
When asked why the government thus far has contracted for only the 700,000 doses, Cicely Waters, an HHS spokesperson, said that "primary protection from COVID-19 related disease including immunocompromised populations is still through vaccination."
But it's likely that millions of immune-compromised people did not get protective immunity through vaccination, and could benefit from a monoclonal antibody, Segev told CNN.
In a clinical trial, protection against Covid-19 lasted at least six months, according to AstraZeneca. The trial was conducted before the arrival of the Omicron variant, but the company says lab tests show Evusheld retains activity against it.
Immune-compromised people who fail to get protective immunity from Covid-19 vaccines tell CNN that the anticipated shortage of Evusheld is the latest in a long list of ways the federal government has failed to protect people who are immune-compromised.
"Frustrated. Abandoned. Forgotten. Angry," said Janet Handal, a kidney transplant recipient and co-founder of an advocacy organization for transplant recipients and others who are immune-compromised, when asked how people in her group feel about the government's efforts to protect them.
When asked about the few options available to immune-compromised people, a senior health official confirmed that Evusheld is the only drug available for pre-exposure prevention. The official added that the government has "built an arsenal of treatments" for people who have Covid-19 and are at risk of progressing to severe Covid-19.
"We haven't put all eggs in one basket, and we continue to grow these supplies and bring more products online to have an array of treatment tools at our disposal," the official wrote in an email to CNN.
The official said Evusheld will be distributed by states, which will in turn distribute them to health care providers "in a manner consistent with clinical guidelines and recommendations for those who should receive them."
"As always, equity remains central to our planning, which is why we are encouraging states to incorporate equity considerations into their distribution plans to ensure this product reaches those who need it most," the official wrote.
Warnings for months about vaccines and the immune-compromised
Handal and other patients want to know why the government contracted for only up to 700,000 doses of Evusheld when it has been expected for months that many more would be needed.
In March, doctors at Johns Hopkins published a research letter in the medical journal JAMA analyzing immune responses of 436 transplant recipients who had received one dose of either the Moderna or Pfizer/BioNTech vaccine.
A Hopkins news release was blunt: "disappointingly," only 17% of the patients produced detectable antibodies in response to the shot.
"This is in stark contrast to people with healthy immune systems who are vaccinated, nearly all of whom mount a sufficient antibody defense against COVID-19," said lead author Dr. Brian Boyarsky.
Over the next few months, studies in the US and other countries emerged that with two or even three doses of Covid-19 vaccines, many people with suppressed immune systems were not getting protective immunity.
The problem lies in the nature of the vaccines. They act like an instruction manual, giving the immune system a recipe for how to make antibodies to the virus that causes Covid. But a suppressed immune system doesn't always know how to read those instructions or is unable to act on them.
"They make very poor immune responses," Dr. Anthony Fauci, President Joe Biden's chief medical adviser told CNN in June. "You're going to have to figure out -- what do we need to do differently to adequately protect these people?"
Monoclonal antibodies work differently than vaccines. They don't give instructions for how to make antibodies. They just deliver antibodies, either through an infusion or shots.
In August, Fauci spoke at a White House briefing about "the benefit of prevention using monoclonal antibodies" and how they could have a "major effect" in the prevention of Covid-19.
In October on CBS's "Face the Nation," former FDA Commissioner Dr. Scott Gottlieb called immune-compromised people one of the "pockets of vulnerability" and said that "we could be using the antibody drugs on a prophylactic basis."
Also in October, a top FDA official mentioned the need for monoclonal antibodies for some immune-compromised patients.
For people who take certain drugs for cancer or autoimmune diseases, "you can pretty well bet they are not going to respond to vaccination, and you probably want to be pursuing some prophylactic strategies with a monoclonal," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said at an event sponsored by the CDC and the Infectious Disease Society of America.
At the same event, Dr. Myron Cohen said that "we need these monoclonal antibodies to be approved for pre-exposure prophylaxis," so that if an immune-compromised person doesn't respond to the vaccine, "we have something to give them."
Cohen, director of the Institute for Global Health and Infectious Diseases at the University of North Carolina School of Medicine, discussed how doctors feel when they don't have an alternative to offer their immune-compromised patients who failed to fully respond to the vaccines.
"It's very upsetting to physicians, the situation that we're in right now," he said.
'I had to DIY it'
This statistic sends chills down the spines of many immune-compromised people: Between 40-44% of fully vaccinated people who have ended up in the hospital with Covid-19 were immune-compromised, according to small studies cited by the CDC.
They know that means the Covid-19 vaccines -- while a miracle for so many -- didn't work well for a lot of people like them.
All summer long, as the Delta variant raged through the United States killing hundreds of thousands of people, the immune-compromised scrambled to try to figure out ways to protect themselves.
Handal, the kidney transplant recipient, says if she had listened to the FDA, she might be dead by now.
In April, as the studies started to accumulate, French health authorities recommended third doses for severely immune-compromised people.
But in April, the FDA was telling Americans -- including the immune-compromised -- to get two shots of Moderna or Pfizer vaccines.
Handal, 71, a technology specialist who worked at the White House during the Clinton administration and now lives in New York City, decided to take matters into her own hands.
As a participant in the Hopkins study, she knew that two doses of Moderna had given her barely detectable levels of antibodies.
On April 28, she received a third shot of a Covid-19 vaccine, after consulting with her nephrologist who said he didn't object, Handal said.
Handal's antibodies went up significantly. While they didn't reach levels seen in people with healthy immune systems, she still felt better protected than with two shots.
More than three months later, on August 12, the FDA gave emergency use authorization for a third shot for immune-compromised people. The next day, the CDC made an official recommendation that immune-compromised people should get a third shot.
Handal shudders to think what might have happened to her if she'd waited for an OK from federal agencies before getting her third shot, given Delta's rampant spread in the US between April and August, and how vulnerable she is with a suppressed immune system.
She knows she's one of the lucky ones. She knew about her low antibody levels because she's in the Hopkins study and she's bold and was willing to defy government guidelines.
"I had to DIY it," Handal said. "The immune-compromised have been left behind in the thinking during this pandemic from the very beginning."
"I'm trying to keep myself alive, and it takes a while for the FDA and the CDC to catch up," she added. "The government has been late to the game. They're not looking out for us, so we've had to look out for ourselves."
An FDA spokesperson said the agency is "committed to quickly and thoroughly" reviewing applications for emergency use authorization.
"The agency worked quickly once clinically meaningful data were available to authorize the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow for the use of an additional dose in certain immunocompromised individuals. The authorization was ultimately based on the science and data available at that time, as has been the case throughout the pandemic," the spokesperson, Chanapa Tantibanchachai wrote in an email to CNN. "The FDA has worked around the clock throughout this pandemic to ensure the public, including immune compromised individuals, has access to the tools needed to best protect themselves, based on the best available data on those tools."
A CDC spokesperson did not respond to a request for comment from CNN.
Kidney transplant recipient finds a loophole
Other immune-compromised patients also say they've had to "DIY it." They said once they learned that their weak immune systems had not fully responded to the Covid-19 vaccines, they had to use their ingenuity to find government loopholes to get monoclonal antibodies to prevent Covid-19.
Many of them describe it as a "Hunger Games"-like endeavor to protect themselves.
Some have succeeded. Others have failed.
Cohen, the UNC infectious disease expert, said he often receives their desperate pleas.
"Every day I get emails -- it breaks my heart," Cohen said. "It's upsetting. They are suffering so much."
Cohen gets these emails because patients notice he's done research on Regeneron, the first monoclonal antibody to receive emergency use authorization from the FDA.
The patients are looking for prevention, but Regeneron is authorized only to treat people with Covid-19 (its most famous patient is former President Donald Trump) or who've been exposed to the virus.
Some patients, however, find loopholes.
Jef Kinney found one because he's relentless.
In April, Kinney, 62, a kidney transplant recipient who lives in Oxford, Maryland, told his nephrologist he'd received two doses of Moderna and planned to get out of the house and start being social again.
"Basically what I got was, 'Whoa, cowboy, it's going to be 2022 before you're out and about.' And I said, 'Pardon me?' " Kinney remembers. "She said, 'You need to lead your life like you're unvaccinated.' "
Kinney was lucky that his physician advised him that because of his weak immune system, the vaccines might not have been very effective for him. Handal and many other members of the patient organization she co-founded, the Transplant Recipients and Immunocompromised Patient Advocacy Group, say last spring and summer, as Delta raged, doctors and transplant centers typically did not reach out to patients to give them this warning.
Fully advised, Kinney, a self-described "data hog," got to work.
A retired vice president at Fannie Mae of innovation development, he's accustomed to doing research, and quickly found the Hopkins studies, and emailed Segev, one of the authors.
Segev wrote back, and Kinney joined the study and learned he did not have any detectable antibodies from his two doses of Moderna.
"I felt pretty naked out there, with no protection," he said.
Kinney found an article online that mentioned Leah Lipsich, an executive at Regeneron. He sent her an email, and Lipsich connected him to the team that runs the company's "compassionate use" program.
Under compassionate use, doctors can ask Regeneron and the FDA for permission to use the company's monoclonal antibody drug under certain circumstances.
Kinney asked one of his doctors to submit the necessary paperwork, and the doctor declined. Other immune-compromised people said their doctors also turned them down because compassionate use applications involve paperwork, and the doctors told them they did not have time to do it for all their immune-compromised patients.
Kinney's family physician, whom he describes as a "small town doc," agreed to submit the paperwork, but then he hit another snag. For compassionate use applications, doctors are required to get permission from an Institutional Review Board. While medical centers have such boards in-house, typically individual doctors don't.
Months passed as Kinney and his doctor worked on the compassionate use application. Then Kinney received an email that his nephrologist, who works at a large medical center, had agreed to submit his paperwork for compassionate use. Kinney finally received his first dose of Regeneron's monoclonal antibody in November, after a seven-month effort to get the drug.
"Let me tell you, if I hadn't been on top of this, none of this would have happened," Kinney said. "You need to be smart and you need to be persistent. It's a hard slog to get people to engage."
"I'm very aggressive in pursuing people. I realize there are people who don't have the resources to do that, or who don't know how to do that, or would look at a doctor and say, 'Well, I can't be bothering a doctor.' I don't have those issues."
Cancer patient finds another loophole
Lisa Wiest managed to get monoclonal antibodies to prevent Covid-19 because she knows how to think on her feet.
Wiest, who has chronic lymphocythic leukemia, learned last spring that her Covid-19 vaccinations had given her barely detectable levels of antibodies.
While her friends and family were getting protection from their vaccines, Wiest, who was 50 at the time, felt vulnerable and unprotected.
In August, Wiest, a federal employee who lives in Rochester, New York, heard that the state of Florida had set up clinics to give monoclonal antibodies. On a trip to visit a friend there in September, she went to a clinic in Clearwater that was offering Regeneron's antibodies to qualified patients.
Wiest told the nurse at the clinic that she had a blood cancer and had received very little antibody response to her first two shots. She thought that would be enough to get the Regeneron infusion.
While the European Commission has authorized Regeneron's drug for prevention, the FDA has not. In the US, Regeneron is only authorized to treat certain people who have Covid-19 or who have been exposed to the virus, meaning they have been within six feet of someone with Covid-19 for a total of 15 minutes or more. Wiest didn't fall into either category.
But the FDA left some wiggle room, and Wiest jumped on it.
The FDA allows someone to get Regeneron if they are immune-compromised and are "in the same institutional setting" as people who have Covid, "for example, nursing homes or prisons."
The wiggle room patients have found is in the phrase "for example" -- someone doesn't have to actually be in a nursing home or prison to be eligible to get the drug.
Wiest explained to the nurse that her husband is a pastor, and since Covid-19 was rampant in their community, potentially she was exposed every Sunday in church.
That didn't cut it.
Then she told the nurse that she'd just gotten off a three-hour flight.
Wiest says that did the trick. The nurse gave her an infusion of Regeneron's monoclonal antibodies.
While relieved to get the medicine, Wiest wishes the federal government would make it easier for people like her to get protected against Covid-19.
"I would like to see the powers that be listen to our little voice. We're a small group, but we're genuinely upset that the vaccine didn't work for many of us. Even with Evusheld, we're going to have to fight and advocate for ourselves," she said.
The state of Florida did not return emails from CNN asking about standards at the state-run clinics.
In early June, Regeneron asked the FDA to expand its emergency use authorization to include prevention for everyone who is immune-compromised, according to Dr. George Yancopolous, Regeneron's president and chief scientific officer.
"We assumed that it was going to happen rapidly and these people would be protected," Yancopolous said. "We are disappointed that there hasn't been faster action on this."
"We don't want to antagonize the FDA," Yancopolous added. "They're pulled in so many directions and [immune-compromised] people sort of fell into a hole."
Chanapa Tantibanchachai, the FDA spokesperson, said the agency is "committing to quickly and thoroughly reviewing all submitted applications, including requests for Emergency Use Authorization, to speed patient access to medicines to prevent or treat COVID-19 provided they meet the agency's rigorous standards."
A Christmas miracle
Much has changed since Kinney and Wiest fought to get monoclonal antibodies this summer and fall. HHS and the FDA say it is "unlikely" that Regeneron "will retain activity" against the Omicron variant.
Evusheld, however, retains neutralizing ability against the highly transmissible variant, according to AstraZeneca.
As immune-compromised patients wait to see if they'll be one of the relatively few to get a dose of Evusheld, all doctors can do is tell their immune-compromised patients to be careful about masking and social distancing -- and to get vaccinated.
In October, the CDC told the immune-compromised they may get a fourth shot at least six months after their third shot of Pfizer or Moderna.
Even though immune-compromised people often don't have a robust antibody response to the vaccine, it's still important to get vaccinated because the shots could help improve other parts of the immune system besides antibodies that are more difficult to measure, Segev said.
Barron, the lymphoma and rheumatoid arthritis patient in Florida, calls the Florida Department of Health and her physicians every day, wanting to know if she'll get one of the precious doses of Evusheld allocated to her state.
For weeks, Barron, the lymphoma and rheumatoid arthritis patient in Florida, called the state health department and her physicians nearly every day, trying to get one of the precious doses of Evusheld allocated to her state.
She made calls to help other immune-compromised patients get the drug, too. She says she's helping others in the spirit of, and in honor of, her beloved cousin, who died of the virus last summer.
Dr. Clinton Potter, who practiced in Naples, Florida, cared for patients with HIV/AIDS, and championed the rights of the LBGT community. Like Barron, he was fully vaccinated but had cancer and a suppressed immune system.
"When he died, I cried because I was lost in grief, but also because he was in my position. I sobbed for it all -- for my vulnerability, for not knowing what was going to take me out of this," Barron said.
This past week, she worked with particular fervor: Ten close family members, all of them fully vaccinated, tested positive for Covid-19.
Then on Thursday, she received a text message.
"Looks like I've received a Christmas miracle," she wrote to CNN."Got a text tonight. I have an appointment to get one of the first and few doses of Evusheld at noon tomorrow, Dec 24."
She wrote that she's getting the shots "thanks to relentless persistence, Janet's group and sheer luck," referring to the support group for people with compromised immune systems.
She thinks of her cousin all the time. Before he died of Covid in August, she often turned to him for guidance on how to stay alive in the pandemic as an immune-compromised person. After he passed away, she felt more alone than ever.
"It's such a lonely place. ... It's very disheartening and frustrating," she said. "You just feel like you're completely figuring it out on your own."
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