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This has been reviewed and updated as of February 15, 2021.

Moderna COVID-19 Vaccine Immunocompromised

As the Moderna COVID-19 vaccine has been rolling out over the last couple of months around the U.S. and the world, people who take immunosuppressant medications, are immunocompromised, or who have autoimmune conditions may have unique questions and concerns about getting a vaccine when it’s their turn.

For example, in a February 2021 poll of our COVID-19 Patient Support Program, 50 percent of respondents wanted to know if the vaccine would be less effective because of their medications , 45 percent wanted to know if the vaccine could cause a disease flare, and 33 percent wanted to know if they would need to stop/skip their immunosuppressant medications before or after getting the vaccine.

This article will address these concerns in detail, but it’s important to know up front that doctors, medical organizations, and public health experts are encouraging most autoimmune and immunocompromised patients to get a COVID-19 vaccine.

“We want patients to get a COVID-19 vaccine — hard stop,” says rheumatologist Jeffrey Curtis, MD, MPH, a Professor of Medicine at the University of Alabama at Birmingham, who led a task force that created guidance on the COVID-19 vaccine for patients with rheumatic diseases for the American College of Rheumatology.

We encourage you check out our main guide: Getting a COVID-19 Vaccine: What to Know If You’re Immunocompromised for a basic overview of the COVID-19 vaccine landscape for people with inflammatory and autoimmune health conditions.

Basic Background on Moderna

Moderna is a biopharmaceutical company based in Cambridge, Massachusetts that was established in 2010. Fun fact: The company name Moderna is short for modified RNA, which is the type of vaccine technology it specializes in.

The company has studied mRNA vaccines in a number of other different germs (most recently for a different kind of coronavirus that causes Middle Eastern Respiratory Syndrome, or MERS), but none have made it to late-stage clinical trials or sought FDA approval.

Moderna developed this COVID-19 vaccine by collaborating with scientists from the National Institutes of Health.

Remember that prior to this year of rapid-fire COVID-19 vaccine development, the fastest timeline for vaccine approval in the U.S. was for the mumps vaccine, which took four years.

Basic Background on the Moderna Vaccine’s Emergency Use Authorization

Granting emergency authorization is not the same thing as the vaccine being officially licensed and approved by the FDA. It means that, given the life-threatening emergency of the COVID-19 pandemic, public health, virology, and infectious disease experts agree that the benefits of the vaccine outweigh potential risks and side effects.

The Moderna COVID‐19 vaccine is for use for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older, according to the FDA. (By contrast, the Pfizer vaccine is authorized for people age 16 and older.)

As part of the EUA, Moderna issued fact sheets about dosing and administration of the vaccine both for vaccine recipients/caregivers and health care providers.

Importantly, these do not state that people who are immunocompromised should not get the vaccine (more on this below).

 

Is the Moderna COVID-19 vaccine considered “live”?

No, the Moderna COVID-19 vaccine is not a live vaccine.

Live vaccines use a weakened (attenuated) form of the germ that causes the actual disease (e.g., the chickenpox vaccine uses a live version of the varicella zoster virus). This kind of vaccine may be more risky for people taking immunosuppressant medication, such as biologics or disease-modifying antirheumatic drugs.

However, the Moderna vaccine, like the Pfizer vaccine, is made completely differently. It cannot infect you with the coronavirus.

It is called an mRNA vaccine.

The coronavirus germ is studded with spike proteins that protrude from it; these spike proteins allow the virus to enter your cells and start replicating. The mRNA vaccine contains messenger RNA, or genetic material that our cells can “read” to make proteins. The vaccine teaches your body’s cells to make the coronavirus spike proteins, so your body learns to recognize them and mount an immune system response.

mRNA is very fragile and cannot be injected directly into the body, so it is surrounded by a layer of fat particles in the vaccine.  It’s this “lipid layer” that also differentiates the Moderna vaccine from the Pfizer vaccine.

The fat layer in Pfizer’s vaccine requires it to be stored at ultracold temperatures (approximately -100 degrees Fahrenheit). The fat layer in Moderna’s vaccine is more forgiving. Moderna’s vaccine can be stored in a standard refrigerator (between 36 and 46 degrees Fahrenheit) for up to 30 days and can also be stored in a standard freezer (-4 degrees Fahrenheit) for up to six months. It can also be left at room temperature for up to 12 hours.

All of this makes the Moderna vaccine easier to ship and distribute, especially to community settings outside of large health care systems and to rural areas.

Can you get the Moderna COVID-19 vaccine if you’re immunocompromised?

Yes. In fact, many major medical organizations are recommending the COVID-19 vaccine for people who have autoimmune conditions, are immunocompromised, or take immunosuppressant medication, including the American College of Rheumatology (ACR), the American College of Allergy, Asthma, and Immunology (ACAAI), the National Psoriasis Foundation (NPF), and the International Organization for the Study of Inflammatory Bowel Disease (IOSIBD).

The Moderna vaccine was authorized for use to prevent COVID-19 in people age 18 and older. People with autoimmune conditions or who are immunocompromised are not excluded from getting the vaccine, but there is not yet direct data on the COVID-19 vaccine in these patients.

That’s because people with these health issues were not part of the clinical trial on which the emergency use authorization was based. This is the big study of just more than 30,000 people who received either the COVID-19 vaccine or a placebo, which found the vaccine to have 94 percent efficacy at preventing COVID-19, according to an FDA briefing document. 

It is common practice to exclude people with certain health conditions, including pregnant or breastfeeding women and those on immunosuppressant medications, from vaccine phase 3 clinical trials.

The goal of these studies is to make sure the vaccine is safe and effective in a large group of healthy adults. Other populations are typically studied in phase 4 (post-marketing) studies that occur after the vaccine has been approved and more is known about their safety and effectiveness.

That said, there’s no reason to think that the Moderna COVID-19 vaccine would be less safe in people who are immunosuppressed or have autoimmune conditions, but there are concerns about it being less effective (more on this below).

The fact sheet for the vaccine says that you should tell your provider about all of your medical conditions, including if you:

  • have any allergies
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects your immune system
  • are pregnant or plan to become pregnant
  • are breastfeeding
  • have received another COVID-19 vaccine

The fact sheet says that you should not get the Moderna COVID-19 vaccine if you:

  • had a severe allergic reaction after a previous dose of this vaccine
  • had a severe allergic reaction to any ingredient of this vaccine

Why weren’t people on immunosuppressant medication included in the clinical trials?

It is common to not include people who are on medications that can affect the immune system, including oral corticosteroids, disease-modifying antirheumatic drugs (DMARDs), biologics, and cancer treatment (chemotherapy, radiation, immunotherapy) in vaccine clinical trials.

This is because these vaccines may work less effectively (be less protective). The trials need to first understand how the vaccines work in healthy adults before they can be studied in other patient populations.

You can read more here about the “exclusion” criteria for the Moderna COVID-19 vaccine trial — who was not allowed to be in the study.

Will the Moderna vaccine be less effective in people who are immunocompromised?

Possibly.

Based on what experts know about how patients respond to other kinds of vaccines (such as the flu or shingles vaccine), there’s good reason to think that COVID-19 vaccines will not work as well in people who take medication that affects immune system function.

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.

Remember that any vaccine usually doesn’t work as well in people who take immunomodulating medication,” says Dr. Curtis. “But even if it doesn’t protect you at the same level as someone your age without your health condition, that does not mean the vaccine is worthless. We want patients to get the vaccine so they have as much protection as possible.”

However, that doesn’t mean that the COVID-19 vaccine doesn’t work — it may just work less well than in people who don’t take these medications. But even a slightly less effective vaccine may still help prevent severe disease that requires hospitalization (or worse).

Think of it this way: If you had a choice between being in a snowstorm wearing a winter coat, hat, gloves, and scarf (fully effective vaccine) versus a just a winter coat (less effective vaccine) versus just a T-shirt (no vaccine), of course you’d prefer having all the winter attire. But having the coat is way better than just the T-shirt.

The vaccine fact sheet says this: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Moderna COVID-19 vaccine.

At a December 2020 meeting of the American Society of Hematology held earlier this month, the nation’s leading infectious disease expert Anthony Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases (NIAID), encouraged people with compromised immune systems to get vaccinated when they have the chance, reported the American Journal of Managed Care.

“It is clear that if you are on immunosuppressant agents, history tells us that you are not going to have as robust a response as if you had an intact immune system that was not being compromised,” Dr. Fauci said at the meeting. “But some degree of immunity is better than no degree of immunity. So, for me, it would be recommended that these people do get vaccinated.”

How effective is the Moderna vaccine?

Here’s how the clinical trial worked. Researchers enrolled slightly more than 30,000 people age 18 and older; half were randomized to get the COVID-19 vaccine and half were randomized to get a placebo vaccine. Participants got two doses of the vaccine four weeks apart. Neither the participants nor the researchers knew who got the vaccine vs. the placebo. Then the researchers wait to see who gets naturally infected with COVID-19 and analyze differences in infection rates in people who get the vaccine compared with the placebo.

Over the next few months, 185 people in the placebo group developed COVID-19, with 30 people having a severe case. Only 11 people in the vaccine developed COVID-19 and none of the cases were considered severe.

The main finding is that vaccine efficacy was 94 percent within 14 days of getting the second dose.

There are signals that the Moderna vaccine offers good protection against severe COVID-19, as all severe cases were in the placebo group and none occurred in the group that received the vaccine. This is important, as preventing severe COVID-19 is what keeps people out of the hospital and reduces deaths.

The efficacy did not meaningfully differ by participants’ age, sex, race/ethnicity, or certain comorbidities (like obesity or diabetes).

What are the Moderna vaccine’s side effects?

Every vaccine has some side effects. Side effects mean your body is reacting to the vaccine and building an immune response. The most common side effects in the clinical trial were pain at the injection site, fatigue, headache, muscle pain, joint pain, and chills. Serious adverse reactions were rare.

There is some evidence that the Moderna vaccine causes more reactions (such as fatigue and muscle and joint pain) than the Pfizer vaccine in clinical trials, STAT reported, but experts caution about making comparisons since the vaccines were not directly pitted against each other.

Moderna’s vaccine fact sheet says the side effects reported with the vaccine include:

  • Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness
  • General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever

What about severe allergic reactions?

Allergic reactions have been a concern for mRNA vaccines from Moderna and Pfizer, but the actual numbers of people who have had severe reactions is very low. The CDC has been monitoring reports of allergic reactions as the vaccine has rolled out.

From December 21, 2020 to January 10, 2021, there were just 10 cases of anaphylaxis after administration of a reported 4,041,396 first doses of the Moderna COVID-19 vaccine, according to data published the CDC’s Morbidity and Mortality Weekly Report. That equates to 2.5 cases per million doses administered. In that same time period, there were 47 cases of non-anaphylaxis allergic reaction reported. Nine of the 10 anaphylaxis cases occurred within the first 15 minutes of vaccination.

As of now, the only people who should not get a COVID-19 vaccine because of allergy-related concerns is very narrow. It includes you if:

  • You’ve had a severe allergic reaction (anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
  • You’ve had an immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG])*
  • You’ve had an immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)*

* The CDC says these groups should not receive an mRNA COVID-19 vaccine at this time unless they have been evaluated by an allergist-immunologist and it is determined that the person can safely receive the vaccine (such as under observation, in a setting with advanced medical care available).

This means that people with more common allergies, such as to food, pets, or environmental triggers, can safely get the Moderna COVID-19 vaccine.

Read more here about what to know if you have concerns about having a history of allergies:

How is the Moderna vaccine given?

The vaccine is injected into the muscle of your upper arm. You will need two doses spaced 28 days apart.

The CDC says that the second dose of the vaccine should be administered as close to these recommended intervals as possible. However, the CDC’s guidance was recently updated to note that the second dose of the Pfizer and Moderna vaccines may be scheduled for administration up to six weeks (42 days) after the first dose if it is not feasible to adhere to the recommended interval.

When will people with autoimmune conditions be able to get the vaccine?

The CDC has been promoting a phased approach to the vaccine rollout, with health care workers and people living and working in long-term care facilities prioritized first, then extending eligibility to older adults and essential workers, and then to people with chronic health conditions. However, it is up to individual states to decide who is eligible to get a vaccine in that state and when.

In some states, people with high-risk medical conditions are currently eligible to receive COVID-19 vaccines. 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.

This article from Verywell Health shows how you can sign up for a COVID-19 vaccine in every state.

In addition, the American College of Rheumatology says in its guidance that people with autoimmune and inflammatory arthritis should be prioritized for vaccination before the non- prioritized general population of similar age and sex.

What We’re Still Learning About the Vaccine 

In addition to forthcoming data on people who are immunocompromised, pregnant women, and children ages 12 and up, there are other important things we still don’t know about the vaccine. This includes:

  • Does it protect as well against new coronavirus variants?
  • Does it protect against asymptomatic cases of COVID-19?
  • Does it prevent transmission of COVID-19?
  • How long does protection last?
  • Is the vaccine less effective (or how much less effective is it) in people taking immunosuppressant medication?

Until this data is available, it’s important to remember that getting vaccinated is not a passport to a pre-COVID life. People who are vaccinated still need to wear face masks and practice social distancing.

Read more about what to do after receiving the COVID-19 vaccine and what to expect from the second dose specifically if you’re immunocompromised or have an autoimmune condition.

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