Are we there yet? It’s a common question and one that millions of Americans have been asking since around the end of March 2020. Are we finally done with this awful pandemic?

Not yet, say scientists at Fred Hutchinson Cancer Center in Seattle, which helped conduct clinical trials on some of the COVID-19 vaccines and whose researchers are still tracking COVID-19 infections and trialing both potential therapies and preventive drugs to kick this creepy new coronavirus to the curb.

“What we’ve learned over the last two years is that every time you think it’s over, there’s always a new twist and turn,” said Dr. Catherine Liu, clinical researcher and associate director of infection prevention at the Hutch’s cancer treatment center. “We thought we were done with delta, and then omicron showed up. And now everybody is trying to move in the direction of regaining normalcy. But we have to be prepared for the possibility of more twists and turns in the future.”

For many, the pandemic is over, despite the fact omicron’s variants are more contagious than ever. The U.S. is still seeing roughly 400 deaths a day per the Centers for Disease Control and Prevention’s COVID data tracker, and masks have been abandoned by shoppers, air travelers and transit riders.

But for the immunocompromised among us, the COVID-19 threat remains and is scarier than ever.

 

“We’re at a new stage of COVID,” said Dr. Steve Pergam, a Hutch researcher and medical director of infection prevention. “We’re at a weird phase. We’ve moved from control and prevention into a phase that’s about openness and getting back to reality. That’s a hard shift for the immunocompromised.”

How can cancer patients and others with weakened or suppressed immune systems stay safe as guidelines give way and precautions dwindle? Read on for advice from patients and Hutch experts.

Stay Up to Date With Boosters

Vaccines and boosters are the best way to protect yourself against severe infection, hospitalization and death. Unfortunately, boosters have not been fully embraced by patients or the public.

“One of the things we’ve seen here is that uptake of boosters has been limited among our immunocompromised patients,” Liu said. “And that’s one of the strongest ways we can prevent complications of COVID as well as hospitalization and death. It’s a key measure to stay protected.”

According to the CDC, 67.4% of the entire U.S. population ages 5 and above is fully vaccinated, which is defined by the CDC as “up to date with all doses in the primary series and all boosters recommended for you.” Just under 50% of the entire U.S. population has received one booster. As of this writing, uptake for the second booster shot is 33.2% in those over age 50 and 40.4% in those over 65.

Liu acknowledged the challenges of keeping up with rapidly changing guidelines around vaccines and boosters. But she said an important bit of guidance has been lost in the fray.

“Immunocompromised people can get up to five doses of the vaccine,” she said. “And that messaging, which has evolved over the last couple of months, has been buried.” (Check out the CDC’s vaccination guidelines for immunocompromised patients.)

Pergam said he’s also disappointed that boosters are flagging, especially in vulnerable patients.

“You’d expect that everybody would be getting their boosters, but very few Americans have gotten them, and immunosuppressed patients are in the same boat,” he said. “A large majority have received two or three, but very few are up to date on others. It doesn’t feel like most of our patients are fully vaccinated.”

Booster shots are relatively easy to get, as well, with a user-friendly website to help locate the nearest clinic to get the shot of your choice. Some locales even offer drive-up vaccine clinics.

Along with those who are immunocompromised because of cancer, HIV or other health issues, those over age 50 are also more susceptible to infection simply due to their immune system’s natural winding-down process. COVID-19 booster shots are key to giving aging immune systems that extra oomph to keep the virus from doing greater harm.

“Only 39.8% of 65+ year-olds are up to date on COVID-19 vaccines,” wrote Your Local Epidemiologist Dr. Katelyn Jetelina in a recent post. “The best thing that this group can do is to fill the holes in their immunity walls by staying up to date [on vaccines and boosters] … We cannot rely on immune systems alone, especially people aged 50+.”

And while those who are severely immunocompromised are at high risk for COVID-19 complications including death, those who have not been vaccinated at all are in an even more precarious spot.

“Unvaccinated people have 42 times the risk of dying from COVID-19 compared to those with two boosters,” Jetelina wrote, referring to a CDC analysis of COVID-19 mortality in April showing the stark difference between death rates in those who are unvaccinated and those who’ve received vaccinations and booster shots.

Fend Off COVID-19 With Evusheld

Additionally, scientists have created a monoclonal antibody cocktail, called Evusheld, to protect those who may be unable to muster up an adequate immune response after vaccination.

“Evusheld is a medication that can help prevent COVID infection among those who may not mount as strong of an antibody response to vaccine,” Liu said. “It provides an additional layer of protection, but it’s been challenging getting it to patients. There’s not a system-wide or nationwide effort of distribution, as with the vaccine efforts.”

Approved in December 2021 and available through the FDA’s Emergency Use Authorization designation, Evusheld is free to eligible recipients (there may be a small administrative fee), but requires extensive patient vetting and documentation, a time-consuming and labor-intensive process.

“The EUA makes the distribution harder,” Pergam explained. “You have to create an infrastructure to deliver it, and it’s a constantly changing process. From a clinical perspective, it’s a heavy lift, but our center is focused on it and committed to it. There’s also a lot of work in education we need to get out to patients. It’s challenging — not everybody wants to receive this.”

And that’s a shame, he said, because “there is really good data suggesting it’s quite helpful.”

Data from one of its Phase 3 trials showed Evusheld, manufactured by AstraZeneca Pharmaceuticals, lowered the risk of symptomatic COVID-19 by 83% compared to placebo over six months,

The problem is getting it to people. While Evusheld is being provided to cancer and medical centers nationwide by the U.S. government, support to help administer the drug is not. So cancer centers have to devote personnel and resources to interviewing and consenting patients, making appointments for the shot, finding a place and a provider to monitor patients for one hour after their injection (a requirement) and setting up follow-up appointments (the shot can be given once every 6 months).

Liu said finding a space where a patient can stay for an hour isn’t easy. At the Hutch’s cancer center, patients wait their hour in the chemo-infusion room, but that is problematic, she said, because “it takes away an infusion slot for others.”

“There are a lot more nuances that make it challenging,” Pergam said. “You have to fill out physical documents required for the EUA. You have to review everything and that takes time. Many hospitals are down a significant number of staff. There are a lot of stresses on the system.”

And it’s not just a local issue — it’s nationwide.

“Many other centers have struggled with this,” said Liu. “If there was a structure, like the vaccination clinics, where people could go in and get consented and get the drug and be monitored that would be great. But we don’t have that kind of set up with Evusheld.”

Infected? Fast Action, Testing Help

Those who do become infected have options, too, specifically the antiviral oral drug Paxlovid, which should be given within five days of symptoms to help prevent COVID from progressing to more serious illness.

But it comes with some risks and side effects.

“Paxlovid is often difficult to use in immunocompromised and other medically complicated patients due to drug-drug interactions or organ dysfunction, such as kidney failure,” Pergam said.

Additionally, reports of rebound infections after a single five-day course of Paxlovid have prompted the FDA to ask the drug maker, Pfizer, to look at testing a second round in patients who rebound.

Other monoclonal antibody therapies are also available for those who are infected. The important thing, Pergam said, is that if you have symptoms — whether immunocompromised or not — don’t wait to seek help.

“Get tested right away,” he said. “And if you’re positive, talk to your doctor about possible treatment options. Early treatment is key in preventing major complications.”

Even if you’re not having symptoms, you still might want to test if you know you’ve been exposed or spent time in a higher risk environment.

According to a recent JAMA Network Open study that looked at 210 patients and employees at a Los Angeles health center (most of whom had received mRNA vaccines), more than half of the people infected with COVID-19’s omicron variant didn’t know it because they were asymptomatic.

“Unawareness may be a highly prevalent factor associated with rapid person-to-person transmission within communities,” the researchers concluded.

So, if you’re planning on spending time with cancer patients or other immunocompromised people, test first. Home tests are still easily available.

Focus on the Vulnerable

Immunocompromised people make up around 3% of the population in the U.S., somewhere between 7 and nearly 10 million individuals dealing with what Pergam calls “a wide swath of diseases, complications and medical therapies.”

Cancer patients with blood cancers and people who’ve had solid organ transplants are highly immune suppressed, he said, and should be the most cautious. Those with a more moderate risk include solid tumor patients (think breast, colon, prostate, lung, etc.) who are currently in treatment as well as rheumatoid arthritis patients taking biologic agents. Low-risk groups, he said, would be those who take low-dose steroids, say, for asthma.

“But we don’t have great tools to say, ‘Here’s where you fit in,’” he stressed. “There are not hard and fast rules.”

And even though cancer patients and other vulnerable folks number in the millions, the COVID-19 response has not directed special efforts toward protecting them.

“There’s not been a focus from public health on immunocompromised or cancer patients,” Pergam said. “We have resources in terms of the availability of Evusheld, but it’s not well advertised or well publicized. There are no messages on radio or TV about it. They’ve basically focused on hospitals and systems to tell immunosuppressed people ‘You’re eligible, come get this.’”

Liu believes public health officials should be more concerned about those at risk — and not just because it’s our moral duty as a society. It’s also a key step in controlling the spread of the pandemic.

“There’s a need to recognize that this population is at high risk, and at risk for having prolonged infection which can give rise to additional variants,” she said. “Investing in ways to optimize protection and treatment of the immunocompromised is indicated even if they represent a small portion of the population. This could have a significant impact on the course of this pandemic and I don’t think that’s been really understood.”

Pergam said part of the problem is perception.

“You think it’s just the bald person in a bed with an IV drip who’s very sick but that’s not what immunosuppression is,” he said. “Immunosuppressed people look like us; they walk around with us. The person bagging your groceries may look normal but could be at deathly risk.”

Although it’s difficult to pinpoint exactly who is dying, older age and lack of vaccination are the two greatest risk factors for severe COVID-19 and its complications.

“People 65 and older make up the group that is both the most likely to be vaccinated (and boosted) and the most likely to die of COVID,” Amanda Montañez wrote in Scientific American in June. “When you separate the age groups, it becomes even clearer that vaccination reduces the risk of death.”

Immunocompromised people, no matter what their age, are also at risk and remain a major concern for oncologists. And Pergam believes this at-risk population may be even higher than then 3% statistics commonly cited.

“I think there’s a larger portion than what’s been reported,” he said. “What’s important is to know is that certain groups — those with hematological malignancies and transplant patients — are at a very much higher risk for complications from COVID-19.”

But help for immunocompromised patients is coming. A team of researchers in Germany is poised to begin a phase 3 clinical trial for a new COVID-19 vaccine — dubbed CoVac-1 — that induces a T-cell immune response in a high proportion of patients with leukemia and lymphoma.

And an updated COVID-19 booster shot is now available.

Additionally, a number of clinical trials for COVID-19 are in the works at the Hutch and around the country, including a Phase 3 trial for a preventive known as molnupiravir and a Phase 2 study looking at therapies for long COVID. Additional clinical trials are in the offing since scientists believe the disease will continue to evolve and circulate through society.

 

 

Buttons, Boosters, Testing and Tenacity

How are immunocompromised patients dealing with the “hard shift” to normalcy?

Ron Cooper, a 73-year-old prostate cancer patient from Louisville, Kentucky, said he has no problem asking people to mask up — especially in health care settings.

“Late this spring, I … innocently walked in the door of an unmasked specialist’s office,“ he wrote in a recent column in Cure Today. “I wore mine [but had to ask] the medical assistant and doctor to put theirs on. They made quite a scene before begrudgingly complying.”

Cooper’s also taken to wearing a large red button that reads “Immunocompromised!” whenever he goes out in public so people will give him his six feet of safe space.

Silke Pflueger, a 57-year-old engineer and metastatic breast cancer patient from Santa Cruz, Calif., said she’s already gotten two boosters and talked to her oncologist about her immune response.

“We did a titer after my first booster and I had a good immune response so there was no need for Evusheld,” she said. “It’s probably time for another, but I’m holding off until they have the new booster for Omicron.”

As for other precautions, Pflueger is doing them all and, as a result, she’s so far avoided the virus. When her husband caught COVID-19, “he was banned from the house and had to sleep in the shed,” she said. But Pflueger makes no apologies for being proactive. It’s worked.

“I wear a mask any time I’m inside and any time there are too many people around me with no air flow,” she said. “And it’s always a N95 or KN95. And when I’m on a plane, I don’t take my mask off just because I have a drink in my hand. I lower it to take a bite or a sip and then put it back on.”

She also asks her guests to test before they come into her home.

“Nobody gets close to me inside unmasked unless they have tested,” Pflueger said. “And not like two days ago, but today — like within an hour of seeing me.”

Good Prep for the Future

Providers and patients all agreed the pandemic is getting old but, also said things are still better than the early pre-vaccine days.

“Our first step is to prevent infection, but if patients do get infected, we have very good therapies to reduce severity of disease, hospitalization and death,” Liu said.

And infection prevention, she added, is something friends and family of immunocompromised patients can do, as well.

“We need to create a cocoon of protection around the patient,” she said.

Pergam said to think of all the different methods of protection like stacked slices of Swiss cheese, where holes in one layer are covered up by cheese in another.

“It’s a multi-layered way to approach it,” he said. “The perfect scenario for immunocompromised people is to be fully vaxed, masked and to have Evusheld. That’s the best way to prevent you developing COVID and its complications. You can still live your life and spend time with family, you just need to be more conscious of that Swiss cheese effect and pay attention to avoid the ‘holes’ or ‘gaps’ in your layers.”

Both scientists also acknowledged — especially in the wake of new public health emergencies — that even as this pandemic wanes, others loom.

“In the past decade and a half, we’ve had Zika, Ebola and now COVID — a number of different pathogens have showed up on our door,” Pergam said. “Some of it is global travel — our ability to get around the world in short amounts of time — but we’re also expanding into new areas and being exposed to new viruses. There’s no question there will be something else — COVID and monkeypox will not be the end of it. There is a real need to reinvest in science education and in research.”

This article was originally published August  25, 2022, by Fred Hutch News Service. It is republished with permission.