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This has been updated as of December 20, 2020.
Now that the U.S. Food and Drug Administration (FDA) has issued emergency use authorization (EUA) for the Moderna vaccine — in addition to a similar vaccine from Pfizer BioNTech — people who take immunosuppressant medications, are immunocompromised, or who have autoimmune conditions have questions and concerns about what these development means for them.
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.
You can also read these other resources on COVID-19 vaccines for people who are immunocompromised:
- Can You Get the Pfizer COVID-19 Vaccine If You’re Immunocompromised or Have an Autoimmune Condition?
- What Major Medical Organizations Are Saying About Getting an mRNA COVID-19 Vaccine If You’re Immunocompromised
- 4 Fast Facts to Share in Response to These COVID-19 Vaccine Myths About Immunocompromised Patients
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.)
Importantly, these do not state that people who are immunocompromised should not get the vaccine (more on this below).
Vaccinations will begin over the next few days across the U.S. The government had initially purchased 100 million doses (which are still being manufactured), and according to CNN, last week agreed to buy another 100 million doses. Some 6 million doses (enough to full vaccinate 3 million people) are ready to start being shipped.
For now, limited supplies of the vaccine are being sent to each state, and each state has its own plan for distribution. Most doses are going straight to hospitals and health care systems to vaccinate health care workers. As more doses become available, people who live and work in nursing homes and long-term care facilities will be next in line.
After that, distribution plans become less clear, but vaccines will be prioritized for essential workers and people over age 65 and with underlying health conditions that increase the risk for severe COVID-19. This may not necessarily include people with inflammatory or autoimmune conditions, but rather is focused more on comorbidities that some of these patients may have, including obesity, heart disease, lung disease, and more.
We will answer common questions below and follow this news closely as it evolves. For example, updated vaccine guidance from the American College of Rheumatology is expected to be issued shortly.
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?
As with Pfizer’s COVID-19 vaccine, the short answer is yes.
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 they are part of certain groups that require extra consideration.
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 may be 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
If you are immunocompromised or have an autoimmune disease, you and your doctor can decide together whether getting the vaccine now is right for you. Keep in mind that for the first couple of months, it will likely only be available to health care workers and long-term care facility worker and residents.
At the just-held 2020 annual meeting of the Advances in Inflammatory Bowel Disease (AIBD), gastroenterologists said they would recommend the COVID-19 vaccine to people with inflammatory bowel disease (Crohn’s and ulcerative colitis, who may be considered immunocompromised).
“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami Miller School of Medicine, told Medscape Medical News. “Although it is true that we don’t know — and won’t know for a while — whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.” She also said that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”
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, but there is not yet data to show this.
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.
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 recent 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.”
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.
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 the severe allergic reactions I’ve read about in the Pfizer vaccine?
So far, two British health care workers with a history of severe allergic reactions (both carried EpiPen-type devices) had a serious allergic reaction (anaphylaxis) after receiving the Pfizer vaccine. So did a health care worker in Alaska, who did not have a history of severe allergic reactions. Another person at the same Alaska hospital also had a serious allergic reaction, but not anaphylaxis. Everyone has recovered or is recovering.
Neither Moderna nor Pfizer reported any serious allergic reactions due to the vaccine during their clinical trials, although these kinds of concerns can result when medications or vaccines are rolled out in larger groups of people.
However, many questions remain until there is more data.
In its authorization, the FDA does not say that people with a history of allergic reactions should not get the vaccine — it only recommends against vaccinating people who:
- had a severe allergic reaction after a previous dose of this [Moderna] vaccine
- had a severe allergic reaction to any ingredient of this [Moderna] vaccine
The fact sheet says that there is a remote chance that the Moderna COVID-19 vaccine could cause a severe allergic reaction. This would usually occur within a few minutes to one hour after getting a dose of the Moderna COVID-19 vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of your face and throat
- A fast heartbeat
- A bad rash all over your body
- Dizziness and weakness
Rest assured that the FDA and vaccine makers like Moderna and Pfizer will be watching this issue very closely as the vaccines roll out in the U.S. If you have a history of severe allergic reactions, talk to your doctor about your concerns, but know that this is not necessarily a reason to skip the vaccine.
Read more here about the mRNA COVID-19 vaccines and allergic reactions.
How is the vaccine given?
The vaccine is injected into the muscle of your upper arm. You will need two doses spaced 28 days apart.
When will people with autoimmune conditions be able to get the vaccine?
The distribution and prioritization of the COVID-19 vaccine is an ongoing discussion. While the U.S. Centers for Disease Control and Prevention provides guidance to states about who should receive priority vaccinations, the decision ultimately rests with your state.
Until production of the Moderna and Pfizer vaccines ramps up and more vaccines get authorized for emergency use (AstraZeneca and Johnson & Johnson expect to report phase 3 trial results early next year), vaccine supply will likely be limited to health care workers and people living/working in nursing homes and long-term care facilities.
People over age 65 and those with underlying health conditions that increase the risk for severe COVID-19 outcomes would come next in line. Keep in mind that this may not necessarily include people with inflammatory or autoimmune conditions, but is rather focused more on comorbidities that some of these patients may have, including obesity, heart disease, lung disease, and more.
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 against asymptomatic cases of COVID-19? (initial research suggests yes)
- Does it prevent transmission of COVID-19?
- How long does protection last?
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.
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