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This article has been reviewed and updated as of April 24, 2021.
On April 13, 2021, the U.S. Food and Drug Administration (FDA) and U.S. Centers for Disease Control and Prevention (CDC) asked states to temporarily halt using the Johnson & Johnson’s COVID-19 vaccine “out of an abundance of caution” after receiving six reports of a rare and severe type of blood clot forming in individuals after receiving the vaccine. On April 23, following a through safety review, the FDA and CDC lifted the pause after determining “the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.”
Now that that the U.S. Food and Drug Administration (FDA) has issued emergency use authorization (EUA) for the Johnson & Johnson COVID-19 vaccine, people who take immunosuppressant medications, are immunocompromised, or who have autoimmune conditions have questions and concerns about what this development means for them.
For example, in a February 2021 poll of our COVID-19 Patient Support Program, 50 percent of respondents wanted to know if the COVID-19 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 the COVID-19 vaccine when it becomes available to them — regardless of which kind of vaccine it is.
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.
The authorization of the Johnson & Johnson vaccine — which is from the company’s pharmaceutical arm, Janssen — comes almost three months after COVID-19 vaccines from Pfizer BioNTech and Moderna began rolling out over the around the U.S. and the world.
The J&J COVID-19 vaccine currently requires only one dose and does not need to be stored at very cold temperatures, which should make distributing and administering the vaccine much easier.
Here’s what else you need to know about the Johnson & Johnson COVID-19 vaccine if you are immunocompromised, take immunosuppressant medication, or have an autoimmune condition.
Basic Background on the Johnson & Johnson 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 Johnson & Johnson COVID‐19 Vaccine is for use for active immunization to prevent COVID-19 in individuals 18 years of age and older, according to the FDA.
Importantly, these do not state that people who are immunocompromised should not get the vaccine (more on this below).
Is the Johnson & Johnson COVID-19 vaccine ‘live’?
No, the Johnson & Johnson 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 Johnson & Johnson COVID-19 vaccine is made completely differently. It cannot infect you with the coronavirus.
This vaccine is considered a “viral vector,” which means using a harmless virus — NOT the virus that causes COVID-19 — to transport a piece of the genetic code for the coronavirus into the body to teach your immune system to recognize it. The Johnson & Johnson vaccine uses a type of virus called an adenovirus, which normally causes the common cold. This makes it good at transporting things into humans. The adenovirus is modified so it cannot replicate and cause disease.
As the CDC explains it, the viral vector enters a cell in our body, and then teaches the cell to make the coronavirus spike proteins, so your body learns to recognize them and mount an immune system response. This causes the immune system to begin producing antibodies and activating other immune cells to recognize and remember the coronavirus.
Then if the body were to encounter coronavirus germs in the future, the immune system would be able to respond faster and more effectively, fighting off the germs before they could cause disease.
Viral vector vaccines cannot cause infection with COVID-19 OR with the virus used as the vaccine vector.
“The Johnson & Johnson vaccine is not live or weakened,” says Jeffrey Curtis, MD, MPH, a rheumatologist and 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.
“The replication machinery has been taken out so [the viral vector] is now just a delivery vehicle,” he explains. “Think of it like a fleet of FedEx trucks that will only deliver the thing that they are supposed to — in this case, the coronavirus spike protein — so the immune system can recognize it, but it cannot make more of itself nor deliver ‘bad things’ that it otherwise might.”
This adenovirus vaccine technology is not brand-new. It has been used in other kinds of vaccines, including for Ebola.
The Johnson & Johnson vaccine works differently from the Pfizer and Moderna vaccines, which are mRNA vaccines. Read more here about how mRNA vaccines work.
Can you get the Johnson & Johnson COVID-19 vaccine if you’re immunocompromised?
Yes. The Johnson & Johnson vaccine was authorized 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 effectiveness of the COVID-19 vaccine in these patients.
That’s because there were not many people with these health issues or taking these medications included in the clinical trial on which the emergency use authorization was based.
The study included nearly 44,000 people, including from the U.S., South Africa, and several South American countries. People with at least one or more comorbidity accounted for 41 percent of study participants, including asthma, cancer, COPD, high blood pressure, diabetes, and HIV. However, people on immunosuppressant medications were not included in the trial.
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 Johnson & Johnson COVID-19 vaccine would be less safe or 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 Johnson & Johnson COVID-19 vaccine if you:
- 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 Johnson & Johnson COVID-19 vaccine trial — who was not allowed to be in the study.
Will the Johnson & Johnson 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 Janssen COVID-19 Vaccine.
At a December 2020 meeting of the American Society of Hematology, 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.”
Should I stop taking immunosuppressant medication after getting the Johnson & Johnson vaccine?
You should not stop taking most medications, but perhaps a select few, such as the disease-modifying antirheumatic drug (DMARD) methotrexate.
Because immunosuppressant medications decrease the immune system’s response to a vaccine, temporarily stopping certain medications after you get a vaccine or OR trying to time when you get the vaccine so it occurs at a certain point during the course of your treatment may help make the vaccine more effective.
While there’s no data on this from COVID-19 vaccines directly, experts are making some recommendations based on indirect evidence from what is known from other kinds of vaccines and how the immune system works generally.
The ACR guidance addresses this in more detail, and you can read more about which medications they suggest pausing vs. continuing here. But this advice needs to be individualized for everyone. Your doctor may have a different recommendation for your situation.
Also, keep in mind that different medications work in different ways, so just because it’s suggested that one medication be temporarily paused after getting the COVID-19 vaccine — say, methotrexate — doesn’t mean that your biologic should necessarily be stopped too.
Two medications that patients have a lot of questions about are methotrexate and rituximab. We have separate resources on these medications here:
- Should You Stop Taking Methotrexate Temporarily After Getting a COVID-19 Vaccine?
- Should You Get the COVID-19 Vaccine If You Take Rituximab?
How effective is the Johnson & Johnson vaccine?
Here’s how the clinical trial worked. Researchers enrolled nearly 44,000 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 one dose of the vaccine (though another trial testing two doses of the Johnson & Johnson vaccine is underway and should have results this spring).
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.
The main finding is that vaccine reduced moderate to severe cases of COVID-19 by 66 percent 28 days after vaccination, but effectiveness varied by geography. Here’s how the efficacy broke down by region, according to Axios:
- Moderate to severe/critical: 72%
- Severe/critical: 85.9%
- Moderate to severe/critical: 64%
- Severe/critical: 81.7%
- Moderate to severe/critical: 68.1%
- Severe/critical: 87.6%
Even though these numbers are lower than the near 95 percent effectiveness reported in the Pfizer and Moderna trials, it’s important to remember that the trials were conducted at different times during the pandemic. The Johnson & Johnson trial had to contend with new coronavirus variants that the Pfizer and Moderna vaccine trials did not.
Experts are consider the Johnson & Johnson vaccine effectiveness to be very good news, emphasizing that it was very effective against severe COVID-19. It reduced the most severe/life-threatening cases by 86 percent in the U.S. and by 82 percent in South Africa. This means the vaccine is protecting people from being hospitalized or dying.
The efficacy did not meaningfully differ for the most part by participants’ age, sex, race/ethnicity, or comorbidities. There was a signal that the vaccine was less effective in older adults (over 60) with risk factors like heart disease or diabetes, but more research is needed because of statistical uncertainty.
What are the Johnson & Johnson 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 headache, fatigue, muscle aches, nausea, and fever. The rates of side effects appear to be milder than those for the Pfizer and Moderna vaccines.
Johnson & Johnson’s vaccine fact sheet says the side effects reported with the vaccine include:
- Injection site reactions: pain, redness of the skin, swelling
- General side effects: headache, feeling very tired, muscle aches, nausea, fever
Serious adverse reactions were rare and there were no reports of severe allergic reactions. There were some rare side effects that were more common in the vaccine group than in the placebo group, which may be due to the vaccine, and which the FDA will be paying attention to as the vaccine rolls out:
- Blood clot conditions (15 vaccine vs. 10 placebo)
- Tinnitus, or ringing in the ear (6 vaccine vs. 0 placebo)
What about severe allergic reactions?
Allergic reactions have been a concern for the Pfizer and Moderna vaccines. There were no cases of serious allergic reactions reported in the clinical trial for the Johnson & Johnson vaccine, but two cases of severe allergic reaction have occurred in an ongoing clinical trial in South Africa, one of which was anaphylaxis, Johnson & Johnson reported during an FDA committee meeting.
The vaccine’s fact sheet says that there’s a remote chance the vaccine could cause a severe allergic reaction, which is why vaccination providers may ask you to remain for monitoring for 15 to 30 minutes.
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
How is the Johnson & Johnson vaccine given?
The vaccine is injected into the muscle of your upper arm. You only need one dose of the Johnson & Johnson vaccine, unlike the Pfizer and Moderna vaccines, which require two doses.
A trial testing two doses of the vaccine is underway. It’s possible that a second dose of the vaccine could be recommended in the future.
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 Johnson & Johnson 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 are still learning 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) in people taking immunosuppressant medication?
The Johnson & Johnson trial did look at asymptomatic cases of COVID-19. Researchers analyzed a subset of 2,650 trial volunteers to see whether people who got the vaccine would be less likely to test positive for COVID-19 without having symptoms. There was a 65 percent reduction in asymptomatic cases in people who got the vaccine compared to the placebo.
However, until more 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 if you’re immunocompromised or have an autoimmune condition.
Get Free Coronavirus Support for Chronic Illness Patients
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Janssen Pharmaceuticals, Inc., which is owned by Johnson & Johnson, is a corporate sponsor of the Global Healthy Living Foundation.
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