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This has been updated as of February 15, 2021.

Pfizer BioNTech COVID-19 Vaccine Immunocompromised

As the Pfizer BioNTech 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 the Pfizer 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. However, Pfizer has said that it will seek full approval by April 2021.

The Pfizer-BioNTech 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 16 years of age and older, according to the FDA.

As part of the EUA, Pfizer has 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 Pfizer COVID-19 vaccine considered “live”?

No, the Pfizer 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 Pfizer vaccine is made completely differently. It cannot infect you with the coronavirus.

It is called an mRNA vaccine and, if approved, will be the first FDA-approved vaccine that uses this technology. The Moderna vaccine uses the same technology.

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 requires the Pfizer vaccine to be stored at ultracold temperatures (approximately -100 degrees Fahrenheit).

Can you get the Pfizer 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 vaccine was authorized to prevent COVID-19 in people age 16 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 nearly 44,000 people who received either the COVID-19 vaccine or a placebo, which found the vaccine to have 95 percent efficacy at preventing COVID-19, according to results published in the New England Journal of Medicine.

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 Pfizer 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 Pfizer-BioNTech 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 Pfizer COVID-19 vaccine trial — who was not allowed to be in the study.

Will the Pfizer 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 Pfizer-BioNTech 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 Pfizer 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:

How effective is the Pfizer vaccine?

 Here’s how the clinical trial worked. Researchers enrolled nearly 44,000 people age 16 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 three 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.

The main finding is that vaccine efficacy was 95 percent by seven days after getting the second dose. However, benefits start about 14 days after the first dose (which shows it takes your body about two weeks to make enough antibodies to mount a response to the virus). The efficacy was 52 percent after getting the first dose.

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

What are the Pfizer 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, and fever. Serious adverse reactions were rare.

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

  • Injection site pain
  • Tiredness
  • Headache
  • Muscle pain
  • Chills
  • Joint pain
  • Fever
  • Injection site swelling
  • Injection site redness
  • Nausea
  • Feeling unwell
  • Swollen lymph nodes (lymphadenopathy)

What about the severe allergic reactions I’ve read about?

Allergic reactions have been a concern for the Pfizer vaccine, 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 14 to 23, 2020, there were just 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer COVID-19 vaccine, according to data published in the CDC’s Morbidity and Mortality Weekly Report. That equates to 11.1 cases per million doses of the vaccine. In that same time period, there were 83 cases of non-anaphylaxis allergic reaction reported. More than 70 percent of the anaphylaxis cases occurred within 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 Pfizer COVID-19 vaccine.

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

How is the vaccine given?

The vaccine is injected into the muscle of your upper arm. You will need two doses spaced three weeks 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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