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This has been updated as of December 20, 2020.

COVID-19 Coronavirus Vaccine

The rapid pace of COVID-19 vaccine news is hard enough for the general population to keep up with. But if you are immunocompromised, it’s even tougher to tell what the evolving headlines mean for you.

Could the vaccine’s effectiveness be dampened by immunosuppressant medications, such as disease-modifying antirheumatic drugs (DMARDs) and biologics? Have clinical trials included people with rheumatic or autoimmune conditions? And when vaccines are ready to distribute, how will people with these chronic illnesses be prioritized?

While there are still many unknowns, experts say it’s great to have reached the point of asking such questions.

“Given this new, uncontrolled wave of COVID-19, the vaccine development so far has been a phenomenal success,” says Grace Lee, MD, Professor of Pediatrics at Stanford University School of Medicine and Associate Chief Medical Officer for Practice Innovation at Stanford Children’s Health.

(Dr. Lee is a member of the U.S. Advisory Committee on Immunization Practices (ACIP), which is a group within the U.S. Centers for Disease Control and Prevention (CDC) that makes recommendations on the use of vaccines. She is a member of the ACIP’s COVID-19 Vaccines Workgroup and Chair of the COVID-19 Vaccine Safety Technical Subgroup.)

Plenty more clinicians who treat immunocompromised patients are feeling optimistic as well.

“Many of my patients are expressing hope that these vaccines will bring an end to the pandemic — and I agree with them,” says Nilanjana Bose, MD, a board-certified rheumatologist with the Rheumatology Center of Houston. “Based on the science, the results at least for Pfizer and Moderna look good. I hope this will provide the herd immunity we all need to get this pandemic under control.”

Where We Stand Now

What is the current status of coronavirus vaccine development? Around the world, there are more than 50 different vaccines in clinical trials on humans and nearly another 100 in pre-clinical phases (being studied in the lab or in animals).

There are a number of leading candidates in various stages of testing, review, and deployment, and they work in different ways. The U.S. front-runners currently making the most headlines are from the following pharmaceutical companies:

  • Pfizer and its partner BioNTech
  • Moderna
  • AstraZeneca in collaboration with the University of Oxford
  • Johnson & Johnson

The Pfizer BioNTech and Moderna vaccines have received emergency use authorization from the U.S. Federal Drug Administration (FDA).

How Vaccines Traditionally Work

When many of us think of vaccines, we think of an injection that contains a live germ that has been weakened (“attenuated”) in order to trigger a controlled immune system response that “trains” the body to fight that germ if encountered in the future. This approach was used to develop vaccines against conditions such as measles, mumps, and rubella.

Live vaccines offer strong protection against disease, but they may not be recommended for people who are immunocompromised because there’s a chance such vaccines could kick off a risky immune response.

Another approach to immunization involves “inactivated” vaccines, in which a “killed” germ is used to teach the body to build immunity. The flu and polio shots, as well as the rabies vaccine, are inactivated. These kinds of vaccines offer less protection (thus requiring boosters), and are therefore thought to be safer for people who are immunocompromised.

The New Technology Behind the COVID-19 Vaccines

The COVID-19 pandemic has forced scientists into new scientific territory. Most of the current excitement has surrounded the vaccines from Pfizer and Moderna. They both employ an innovative mechanism of vaccination using mRNA, which has been pursued in the development of other recent vaccines, but none have been approved yet.

mRNA Vaccines

Their approach makes use of messenger RNA (mRNA), which carries instructions from the coronavirus’s genetic code that show your cells how to manufacture the coronavirus “spike” protein (those protrusions dotting the coronavirus). This teaches your body to recognize the spike protein on coronavirus germs as foreign and mount an immune system response.

Because mRNA are delicate, this vaccine is encased in a lipid particle envelope to transport the mRNA inside human cells.

The Pfizer and Moderna “envelopes” are made differently from each other, which is why the Pfizer vaccine would need to be stored at approximately -100 degrees F (presenting distribution challenges) and the Moderna vaccine can be kept for a time in a standard refrigerator.

Both vaccines require two doses about three weeks (Pfizer) to a month (Moderna) apart.

Viral vector vaccines

At the same time, AstraZeneca and Johnson & Johnson have been testing a different kind of vaccine called a viral vector vaccine. This uses the virus that causes the common cold (called adenovirus) to get the coronavirus mRNA into cells, where it teaches the body to recognize the coronavirus spike protein. The adenovirus is genetically modified so it cannot replicate and cause disease.

The AstraZeneca vaccine requires two doses. Johnson & Johnson is studying a two-dose and a single-dose version.

Are Any COVID-19 Vaccines Approved?

On December 11, 2020, the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to the Pfizer vaccine based on the data from its phase 3 clinical trial, which has been shown to achieve 95 percent efficacy. The first doses of the vaccine were promptly distributed to hospitals and health care systems across the U.S. to start being administered to health care workers. A week later on December 18, the Moderna vaccine, which has 94 percent efficacy, received emergency use authorization.

EUA is not official FDA approval, but would allow the vaccine to be used because there’s a life-threatening emergency and the safety and efficacy data show benefits that outweigh potential risks.

The Pfizer vaccine has also been approved for use in the United Kingdom, Canada, and several countries.

AstraZeneca and Johnson & Johnson are completing phase 3 clinical trials in the United States and are expected to apply for emergency use authorization in early 2021.

Are Immunocompromised People Included in COVID-19 Vaccine Clinical Trials?

When it comes to any new vaccine, people living with inflammatory or autoimmune conditions — such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; and multiple sclerosis — have long had vaccine worries that the general public doesn’t. There are two general main concerns:

  • That a vaccine might unsafely activate their immune system
  • That immunosuppressant medications might interfere with the vaccine’s effectiveness

In the case of the COVID-19 vaccines, there is not a lot that can be definitively said about how people with such medical conditions might react because they were not included in the clinical trials.

This is not unique to COVID-19 vaccines. It’s common for vaccine trials to start by only studying healthy people without medical conditions or medications that could affect the results.

“The issue of greatest concern in the immediate period for patients with immune-mediated inflammatory disease is that this group was not studied in trials,” says Leonard Calabrese, DO, head of the Cleveland Clinic’s Section of Clinical Immunology. “After the first vaccine is approved, when we ask for data on people with rheumatoid arthritis or Crohn’s disease who are on steroids or targeted therapies or immunosuppressant therapies, we will not have an immediate answer.”

“People with unstable health conditions, such as cancer or who are treated with immunosuppressant medications, are excluded from phase 3 studies, including the ones we are doing for the [AstraZeneca] COVID vaccine,” says Mario Castro, MD, Vice Chair for Clinical and Translational Research in the Department of Internal Medicine and a pulmonologist at the University of Kansas School of Medicine, via email. He is a principal investigator in the AstraZeneca trial.

Examples of Clinical Trial Exclusion Criteria

Clinical trials for vaccines include a protocol that details who can participate (inclusion criteria) and who cannot participate (exclusion criteria).

Indeed, a review of the published exclusion criteria for the AstraZeneca study shows that — with narrow exceptions — volunteers in “any confirmed or suspected immunosuppressive or immunodeficient state” were not allowed to participate.

As for the Moderna vaccine, clinical trials excluded participants with an “immunosuppressive or immunodeficient state,” as well as those who have “received systemic immunosuppressants or immune-modifying drugs for >14 days in total within six months prior to screening.”

The Pfizer clinical trials’ exclusion criteria barred “immunocompromised individuals with known or suspected immunodeficiency” as well as “individuals who receive treatment with immunosuppressive therapy,” and even people who were “anticipating the need for immunosuppressive treatment within the next six months.”

Johnson & Johnson’s trial allows people with certain underlying medical conditions to participate in if their signs and symptoms are stable and well-controlled. “Participants with clinical conditions stable under non-immunomodulator treatment (e.g., autoimmune thyroiditis, autoimmune inflammatory rheumatic disease such as rheumatoid arthritis) may be enrolled at the discretion of the investigator. Non-immunomodulator treatment is allowed as well as steroids at a non-immunosuppressive dose or route of administration.” However, people on immunosuppressant medications would likely be excluded.

So How Do We Get Vaccine Data on Immunocompromised People?

It’s important to know that just because these patient populations were not included in the initial clinical trials does not mean patients can’t get the vaccine.

People with autoimmune and inflammatory diseases and those on immunosuppressive therapies will be evaluated after the vaccines are on the market, which is common practice.

“Typically, patients are studied in phase 4 trials, or post-marketing surveillance, when a drug has been FDA approved,” says Dr. Castro. With the information from phase 3 studies, he adds, scientists know what the expected efficacy and safety of a vaccine is so when they can begin studying “more difficult patient populations” they have some idea of what to anticipate.

But it’s important to remember that providers and patients dealing with rheumatologic and autoimmune conditions have navigated this same data blind spot every time a new vaccine comes out.

“This is very, very typical,” Dr. Calabrese says. “If you take the most recent vaccine for shingles, there were 36,000 patients in the clinical trial, but there were only a few score of patients with autoimmune disease, and none of them were on significant immune suppression. So now it’s several years later and we’re just figuring it out.”

Understanding Potential Safety and Efficacy Issues for Immunocompromised Patients

Even in the absence of specific data, experts in rheumatologic and autoimmune diseases have enough clinical experience to make educated guesses on a number of issues. Here are answers to common concerns.

Could COVID-19 Vaccines Activate the Immune System in an Unsafe Way?

The current COVID-19 vaccine candidates are not considered “live,” which reduces concerns about their safety in immunocompromised people.

“We have no reason to believe these vaccines will be any less safe in an immune-mediated inflammatory disease population,” says Dr. Calabrese. “These are not live vaccines, and there’s no reasonable concern that our patients will have higher risks. But as with anything, it deserves careful study.”

“If you’re taking immunosuppressant biologics, say, for arthritis, live attenuated vaccines are not recommended,” says Vinicius Domingues, MD, a rheumatologist in Daytona Beach, Florida, explaining that a dose of a live virus that would not trigger disease in healthy patients could trigger disease in someone who is immunosuppressed. “But these new COVID-19 vaccines don’t carry live viruses. They can’t trigger disease, which is great for this patient population.”

While it’s helpful to hear that the mRNA and viral vector COVID-19 vaccine candidates are safer for immunosuppressed patients than live vaccines, it’s reasonable to wonder how the safety profiles of the mRNA and viral vector mechanisms compare to each other.

Based on these two vaccine mechanisms, we have no reason to believe there’s a difference in safety between them for immunocompromised patients, says Dr. Bose. But she adds that we don’t yet have the data to know for sure.

Here is what major medical organizations are saying about getting a COVID-19 vaccine if you’re immunocompromised.

Is This Super-Fast Vaccine Development Safe?

Another concern is the lightning-fast development of the COVID-19 vaccines, which has left even people who don’t have chronic conditions worrying if corners are being cut.

“Obviously this is a compressed timeline, but we have had very strong processes in place for a long time that determine how we review evidence,” says Dr. Lee. “All the steps of our routine decision-making process for every vaccine will be the same for this vaccine. It’s just that we’re having many more meetings on a much tighter timeline.”

In addition, she says, the CDC has set up extra surveillance for COVID-19 vaccines. So multiple systems will be in place in order to have all eyes on safety if and when approval occurs.

Do the Vaccines Work as Well in Immunocompromised Patients?

Beyond safety questions, there are concerns regarding effectiveness. People who take immunosuppressant medications wonder if they might have a dampened response to a vaccine.

People who are on immunosuppressant medication tend to mount a less strong response to vaccines generally, noted Kevin Winthrop, MD, MPH, Professor of Infectious Diseases, Ophthalmology and Professor of Public Health and Preventive Medicine at Oregon Health & Science University in Portland, during a Facebook Live discussion with the Spondylitis Association of America.

Dr. Domingues explains why: “For you to have a good response to a vaccine that achieves protection from disease, your body needs to be able to mount a strong immune response in general. But for patients who are on immunosuppressant medications, their response is weakened.”

This is true for all vaccines, not just for the COVID-19 candidates, he points out. One well-known example is patients taking methotrexate or biologic drugs who are due for a flu vaccine. “The efficacy can be lower for people on these medications because their immune response is weaker overall,” Dr. Domingues adds.

However, there’s no data yet to suggest whether or to what degree the efficacy of COVID-19 vaccines may be reduced in people on these medications.

As doctors and researchers gather this information over time, it could lead to a different dosing regimen or getting booster shots sooner for certain patient groups.

What About Vaccine Side Effects If You’re Immunocompromised?

Another common worry involves the side effects that are expected from the COVID-19 vaccines. Mild side effects from vaccines are common and to be expected. They’re a sign that your body is revving an immune response. Common side effects from the first COVID-19 vaccines include:

  • Pain and stiffness at the injection site
  • Fatigue
  • Headache
  • Muscle aches
  • Joint stiffness

Dr. Bose is advising patients to be prepared for possible discomforts including fever and body aches, which she says “seem more pronounced than with other vaccines.”

For his part, Dr. Domingues feels the immediate side effects “seem to be quite reasonable and safe,” but points out there is not yet any data on the possibility of long-term side effects. However, considering the known risks of COVID-19 infection, his recommendation is clear: “Overall we still believe the risk benefit analysis is in favor of vaccination by far.”

Public health experts are keeping an eye on severe allergic reactions in people with a history of allergic reactions after reports from two people in the U.K. who experienced symptoms after getting the Pfizer vaccine. Read more here about the mRNA COVID-19 vaccines and allergic reactions.

How Are People with Chronic Conditions Being Prioritized for the Vaccine?

The answer to this question has drawn a great deal of debate among groups and agencies including the APIC, CDC, and the U.S. Department of Health and Human Services.

“Assuming the vaccine looks safe and effective for use in the general population, our goal is to vaccinate as many individuals as want to be protected from COVID-19,” says Dr. Lee. “But obviously we won’t have 330 million doses available tomorrow, so that’s where allocation strategies become important.”

The ACIP has held public meetings and published papers on the ethical frameworks being considered to determine the groups that will be prioritized to receive vaccines first. As of a December 1, 2020 ACIP meeting, the first phase should include health care workers and long-term care facility residents and workers.

Following those groups would be certain essential workers, adults 65 and older, and those with underlying conditions that increase the risk for severe COVID-19 illness. This doesn’t necessarily include autoimmune conditions, but rather focuses on many conditions that are comorbidities for inflammatory and autoimmune patients, including: obesity, diabetes, COPD, heart conditions, chronic kidney disease, cancer, sickle cell disease, and those who have undergone solid organ transplantation.

In addition, the American College of Rheumatology has advised that rheumatology patients taking at least 10 mg of prednisone daily should receive priority vaccination based on indications that this group is at higher risk of hospitalization if infected with the coronavirus.

The Bottom Line

So how should patients handle all these unknowns? It starts with a conversation with the doctor(s) who treats your main chronic condition, such as your rheumatologist or gastroenterologist.

“I think it’s important for everyone to try to get vaccinated,” says Dr. Bose. “I would advise anyone who tells me they have concerns to get more informed. We are optimistic this will work.”

“I’m confident we’ll be engaging in shared and informed decision making with patients who can’t wait for perfect data,” says Dr. Calabrese.

Remember that just because there is no data yet  in people on disease-modifying or biologic medication doesn’t mean the vaccine is not safe for you. Because the vaccines are not live, taking immunosuppressant medications should not have an impact.

Dr. Calabrese will help his own patients decide when to get the vaccine by factoring in the severity of their underlying disease as well as their risks for severe COVID-19, such as having high blood pressure, obesity, or kidney disease. He’ll also consider their concerns regarding COVID-19, which range from ‘I’m not worried because I’m hunkered down’ to ‘the pandemic is ruining my life.’

It may be reassuring to know that many rheumatologists and other health care providers that CreakyJoints and the Global Healthy Living Foundation regularly work with are eager to get a COVID-19 vaccine, including those who live with inflammatory conditions. Among them is Hillary Norton, MD, a Santa Fe-based rheumatologist who has ankylosing spondylitis. “I personally cannot wait to get the vaccine,” she says, noting that she hopes it will allow her to see family members (like her father) and travel again. Read here about a lupus patient on immunosuppressants who received the Pfizer COVID-19 vaccine.

In the meantime, just because vaccines are finally on the way doesn’t mean we can loosen up on the protective habits that we know help prevent COVID-19 transmission. Doctors are urging patients to continue wearing masks, maintaining social distancing, and washing hands.

“People with autoimmune conditions can have a reduced response to any threats to their immune system and they may be vulnerable to COVID-19 [complications], but also to flu and other infections,” says Bala Murugan, MD, Acting Chief Medical Officer at the Arkansas Department of Health and board member of the National Association of Chronic Disease Directors. “In a pandemic we expect that they follow the three Ws — wearing masks, watching distance, and washing hands — carefully more so than the general population because of the nature of their underlying immune conditions.”

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Interview with Bala Murugan, MD, Acting Chief Medical Officer at the Arkansas Department of Health and board member of the National Association of Chronic Disease Directors

Interview with Grace Lee, MD, Professor of Pediatrics at Stanford University School of Medicine and Associate Chief Medical Officer for Practice Innovation at Stanford Children’s Health

Interview with Hillary Norton, MD, a rheumatologist in Santa Fe, New Mexico

Interview with Leonard Calabrese, DO, head of the Cleveland Clinic’s Section of Clinical Immunology

Interview with Maria Danila, MD, a rheumatologist at the University of Alabama Birmingham

Interview with Mario Castro, MD, Vice Chair for Clinical and Translational Research in the Department of Internal Medicine and a pulmonologist at the University of Kansas School of Medicine

Interview with Nilanjana Bose, MD, a board-certified rheumatologist with the Rheumatology Center of Houston

Interview with Vinicius Domingues, MD, a rheumatologist in Daytona Beach, Florida

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