The initial batch of COVID-19 vaccines are now available in the U.S. following incredibly fast — “warp speed” — development and testing.
Not so incredibly, there’s a lot of confusion among cancer patients — as well as their oncologists and caregivers — as to whether the vaccine is a good idea or a bad idea for somebody dealing with cancer.
The two Food and Drug Administration-approved vaccines from Moderna and Pfizer-BioNTech, each requiring two shots a few weeks apart, were more than 94% effective at keeping this new coronavirus in check in testing on thousands of volunteers in clinical trials. But only a handful of the clinical-trial participants were cancer patients.
Other COVID-19 vaccines are in development and will be available in the months ahead. Additional trials involving subpopulations (think children, pregnant women, people with health issues) are also in the works.
But what do we do now that states are ramping up the vaccination efforts to eligible groups?
Patients with cancer are particularly vulnerable to COVID-19 because of the immunocompromising nature of cancer treatments. On top of that, progressing cancer itself depletes the immune system and leaves patients susceptible to infection.
Does that mean cancer patients should be first in line for their shot — or last? If they’re in treatment, could a vaccine make them sicker? What about those with metastatic disease who are always in treatment — can they get it? And are survivors the same as the general public?
We checked in with patients and the national experts, clinicians and infectious disease experts with Fred Hutchinson Cancer Research Center, which used the longstanding infrastructure of its HIV Vaccine Trials Network to create the COVID-19 Prevention Network (or CoVPN) that directed many of the COVID-19 vaccine trials.
Read on for their insights and answers or delve deeper into how Fred Hutch scientists are helping to defeat this deadly virus.
The Centers for Disease Control and Prevention has a committee that determines how to equitably distribute all vaccines. Known as the Advisory Committee on Immunization Practices, or ACIP, it currently recommends COVID-19 vaccines be distributed in phases and tiers.
Dr. Steve Pergam, director of infection prevention at Seattle Cancer Care Alliance, said the vaccine is going first to the groups most at risk: health care workers, people in long-term care facilities, people over 75 and front line essential workers.
Then come people with additional medical issues, such as cancer.
“Cancer patients are basically Phase 1C at the moment, unless they meet other criteria,” he said. “They’re early in the process. If you’re trying to stop community transmission, you focus on groups at high-risk for transmission and complications first. We all want to prioritize high-risk groups, but we also need to do it in a way that’s equitable.”
But there is confusion about the guidelines — and they are evolving as availability increases. Millions of Americans have medical problems — heart disease, diabetes, hepatitis, the list goes on and on — and the guidelines have raised questions about who is being prioritized.
Not quite. Researchers still don’t know whether the vaccines can prevent a person from spreading the coronavirus. All agree it’s imperative to continue to wear a mask and practice social distancing until we reach herd immunity via the vaccine.
National infectious disease expert Dr. Anthony Fauci said this would occur when 70% to 85% of the American population is vaccinated.
THE COVID-19 VACCINES
Phase 1 guidelines
Below are ACIP guidelines for the first three tiers of vaccine distribution in the U.S. for Phase 1. They are meant to be “flexible and adaptable,” said CDC director Dr. Robert Redfield. New guidance is coming out daily. As of this writing, the CDC is recommending vaccines for anyone 65 and older. Washington state offers this guidance.
Phase 1, Tier A: Health care personnel and residents of long-term care facilities.
Phase 1, Tier B: People 75 and over and front line essential workers. This includes first responders (firefighters and police officers); corrections officers; food and agricultural workers; U.S. Postal Service workers; manufacturing workers; grocery store workers; public transit workers, and those who work in education, such as teachers, support staff and child care workers.
Phase 1, Tier C: People 65 to 74 years old; people aged 16 to 64 with medical conditions that increase the risk for severe COVID-19, and essential workers not previously included in the previous phases. This includes people in transportation and logistics, water and wastewater, food service, construction, finance (such as bank tellers), information technology and communications, energy, legal, media, public safety (like engineers), and public health.
Public health researcher and oncologist Dr. Gary Lyman said it’s clear the vaccine is safe for most people — and that includes most cancer survivors on the other side of treatment. Those in active treatment, he said, should also be vaccinated and at the earliest opportunity.
“The data we have on these vaccines shows they’re remarkably safe in the general population based on the trials,” he said. “Admittedly, very few patients with active cancer or in active therapy were included in the trials. But having gone through all the documentation for both of these vaccines, it looks remarkably safe.”
Cancer patients were excluded from vaccine trials if they’d received chemotherapy or immune modifying drugs within six months of screening. This is standard operating procedure in vaccine development. Pregnant women, children and those with other immunosuppressive conditions were also excluded from early trials. New trials are underway to ensure the vaccines’ safety and effectiveness in all of these vulnerable populations. Trials were large and rigorous, conducted on more than 50,000 people.
“Most cancer patients, even those in treatment, should go ahead and get vaccinated when it becomes available,” he said. “Ideally between cycles of systemic immunosuppressive therapy.”
Patients in treatment should work with their oncologists to time the two-shot vaccine, he said.
“Using the flu vaccine as a prototype, it seems to be significantly better to give the vaccine between cycles rather than at the same time as the cytotoxic [cell-killing] therapy,” he said.
Lyman, who helped launch the COVID-19 and Cancer Consortium, or CCC19, felt the vaccine was a much safer bet than the risk of COVID-19 infection and its complications for those in active treatment.
“I have no real concerns that there will be big surprises when it comes to safety for the cancer patient population,” he said. “The risk to these patients from COVID is high and the risks from the vaccines appear very low. Most should be vaccinated. At the same time, we need to learn from these patients and follow them closely for both efficacy and safety.”
A recent review by members of the American Association of Cancer Research’s COVID-19 and Cancer Task Force strongly recommended priority vaccination for patients with active cancer.
“We conclude that patients with an active cancer should be considered for priority access to COVID-19 vaccination, along with other particularly vulnerable populations with risk factors for adverse outcomes with COVID-19,” they wrote in AACR’s Cancer Discovery journal.
Early vaccination should go “to patients who are currently receiving treatment for cancer or have an advanced cancer that may result in increased risk of complications from COVID-19.”
Special consideration should be given to patients with hematologic malignancies and lung cancer, they wrote.
Fred Hutch vaccine expert and director of infection prevention at SCCA Dr. Steve Pergam
Lyman agreed with their assessment, adding that the risk for serious COVID-19 complications increases considerably in those with progressing cancer, the elderly and those with additional medical conditions.
“I would prioritize patients with active cancer as well as those on active cancer therapy,” he said. “We’re fighting a pandemic where cancer patients are at three, four, or five times greater risk for fatality than others. It’s a risk-benefit equation. Their risk from COVID-19 is exceptionally high.”
Fauci specifically recommended vaccinating blood and marrow transplant patients during the recent American Society of Hematology conference: “If you’re immunosuppressed, history tells us you won’t have as big of a protective response. But some is better than none.”
Pergam, a high-risk essential worker and cancer survivor who got his shot last week, agreed that the vaccine was likely safe for all cancer patients, even those in active treatment.
“Cancer patients are not expected to be at risk for complications of the vaccine,” he said. “They are at risk for acquisition and complications of the virus.”
When it comes to non-cytotoxic therapies such as PARP inhibitors or anti-hormonal therapies often used in breast and prostate cancer management, Lyman said vaccinating should be fine.
“I would treat these patients as I would the general population — or someone who was months or years out from treatment who has a relatively active immune response,” he said.
Short answer: yes.
According to the CDC, those who’ve been infected and recovered from COVID-19 will have some natural antibodies to the virus. The vaccine will boost that response and make sure there’s long-lasting protection.
Pergam, who went through both a kidney transplant and cancer in years past, said he had mild arm soreness from his COVID-19 vaccine, but that was it.
“No real side effects at all,” he said.
Pergam shared his shot on Twitter, as have many in health care — including oncologists, who are passing on the intel to the cancer community.
“Note significant lymph node swelling after COVID-19 vaccine,” Maryland breast cancer oncologist Dr. Tatiana Prowell commented via tweet when Dr. Erika Hamilton shared a picture of the adenopathy she developed in her neck after each of her shots.
“To be clear, this is not a dangerous thing,” Prowell wrote. “Heads up for people with cancer, the clinicians who care for them in or out of clinical trials, and radiologists reading studies. Don’t mistake this for progression.”
Lymph node swelling — or lymphadenopathy — was seen in 0.4% of subjects in the Pfizer trial, a total of 38 cases; three were found in the placebo arm. Lymph nodes, which are found in the neck, under the arms, around the clavicle and throughout the body, are part of the body’s immune system.
Hamilton said her swelling went away after four to five days. But for someone with a history of cancer?
“They’d be worried about progression/recurrence if they found this in their neck,” she said.
Breast cancer patients and others who’ve had lymph nodes taken surgically should note this side effect as it might trigger lymphedema. Lyman said patients with lymphedema, if concerned, should talk to their doctor and possibly get vaccinated elsewhere on their body.
Many have breezed through with few issues. Kathi Kolb, a 66-year old breast cancer survivor and physical therapist from South Kingstown, Rhode Island, was a little tired from her first shot, but that was about it.
“Part one of this COVID-19 vaccine was easier than the flu vaccine,” she said. “It didn’t even make a mark on my arm."
The second shot, however, left her with arm soreness, fatigue and a headache.
Pergam encouraged those who get vaccinated to sign up for the CDC’s V-Safe tool, which is tracking reactions to the vaccine.
“You sign up when you’re vaccinated and then six hours later, you get a text asking you to fill out any side effects,” he said. “Then they text you once a day so you can continue to document any symptoms. It’s going to provide early insight into the side effects of the vaccines.”
The American Cancer Society’s website, which also recommends cancer patients discuss the vaccine with their doctor, said side effects that have been reported include pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever (all of these are short-term).
Lisa Rice, a 59-year-old political strategist and nonprofit executive from Washington, D.C., was diagnosed with breast cancer in 2017 and has been out of treatment for a few years. As a survivor, she could get vaccinated as soon as her category opens up.
But she’s holding off. Not over concerns about cancer, but allergies.
“I have several severe allergies, which rules out the Pfizer and Moderna vaccines,” she said. “For me, it wouldn’t be worth the risk to my health to take [them]. I’ll just wait for a single-dose vaccine. There are several in trial now.”
Rice, who’s had “bad, bad allergies” since she was a child, said she's particularly interested in “a single-dose vaccine, like the Johnson & Johnson version, currently in third-phase testing."
An article published in the journal,Science said the severe allergy-like reactions seen in 12 people who received the Pfizer-BioNTech “may be due to a compound in the packaging of the messenger RNA that forms the vaccine’s main ingredient.” The Moderna vaccine contains the same compound — polyethylene glycol or PEG — which has not been used in a vaccine before but is commonly used in toothpaste, shampoo, various gels and many drugs, occasionally triggering severe allergic reactions — anaphylaxis.
Last week, the CDC reported a total of 29 cases of anaphylaxis following approximately 5.3 million doses of one or the other COVID-19 vaccines, and Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, stressed the importance of continued vaccinations because of the severe nature of pandemic. Lyman agreed.
“The rate of serious adverse events in both the trials and the larger vaccinated population appears to be very low,” he said.
By comparison, COVID-19 is currently claiming around 3,000 lives a day in the U.S. (killing 1 in 1,000 people). Many who contract it develop long-term complications. It’s now the third-leading cause of death in the U.S.
Lyman, Dr. Josh Hill and others on an ASCO/Infectious Disease Society of America webinar about the COVID-19 vaccine and cancer patients said only those with a history of anaphylaxis to an mRNA vaccine (most people have not received them) or to drugs that include the PEG component should hold off on the current vaccines.
Those with lesser allergic reactions from other vaccines and injectable therapies should be monitored for up to 30 minutes. Monitoring, they all agreed, is crucial.
The CDC provided a report on 21 allergic reactions from the Pfizer-BioNTech’s COVID-19 vaccine as well as a table with additional information on outcomes.
As for the slow rollout, Pergam stressed that patients are already being vaccinated because many are part of other high-risk groups.
“Many of those people are also cancer patients,” he said. “There are health care workers who are cancer patients. There are many essential workers who are currently getting cancer care. It’s not just about what your disease is, but what your risk is. Cancer patients and others will be included in all these groups in a subset.”
And even those at high risk may need to be extra patient as the rollout revs up.
“I impatiently called my doctor's office and tried the fact that I am old (almost 73), had cancer and a bone marrow transplant and live in Los Angeles, but I have to wait,” wrote Dr. Susan Love, cancer survivor, researcher and author of what’s often termed the breast cancer bible. “Meanwhile sheltering in place!”
Diane Mapes is a staff writer at Fred Hutchinson Cancer Research Center. She has written extensively about health issues for NBC News, TODAY, CNN, MSN, Seattle Magazine and other publications. A breast cancer survivor, she blogs at doublewhammied.com and tweets @double_whammied. Email her at email@example.com.
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