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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 Pfizer BioNTech COVID-19 vaccine — which the New York Times called a “historic turning point” in the pandemic — people who take immunosuppressant medications, are immunocompromised, or who have autoimmune conditions have questions and concerns about what this 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.
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.
Importantly, these do not state that people who are immunocompromised should not get the vaccine (more on this below).
Vaccinations have begun across the U.S. (A handful of countries have already authorized and started to administer it, including the United Kingdom, Canada, and Mexico.) Pfizer has a deal with the U.S. government to supply 100 million doses (enough to vaccinate 50 million people) by March 2021. 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 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, which received emergency use authorization just a week after the Pfizer 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?
The short answer is yes.
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 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 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 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 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
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.”
In a press release, the American College of Allergy, Asthma, and Immunology said the “Pfizer-BioNTech COVID-19 vaccine is not a live vaccine and it can be administered to immunocompromised patients. Physicians and other providers should inform such immunocompromised patients of the possibility of a diminished immune response to the vaccine. We do not know at this time if people with a weakened immune system will respond to the vaccine and be protected from 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 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, 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 Pfizer-BioNTech 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 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
- Muscle pain
- Joint pain
- Injection site swelling
- Injection site redness
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy)
What about the severe allergic reactions I’ve read about?
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 vaccine. This prompted British drug regulators to recommend against the Pfizer vaccine in people who have a history of severe allergic reactions.
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 [Pfizer COVID-19] vaccine
- had a severe allergic reaction to any ingredient of this [Pfizer COVID-19] vaccine
The fact sheet says that there is a remote chance that the Pfizer 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 Pfizer 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
According to Pfizer, people with a history of an anaphylactic reaction to any vaccine were excluded from the studies. The New York Times reported:
“Among those who participated in the Pfizer trials, a very small number of people had allergic reactions. A document published by the FDA said that 0.63 percent of participants who received the vaccine reported potential allergic reactions, compared to 0.51 percent of people who received a placebo. In Pfizer’s late-stage clinical trial, one of the 18,801 participants who received the vaccine had an anaphylactic reaction, according to safety data published by the FDA on Tuesday. None in the placebo group did.”
Rest assured that the FDA and Pfizer will be watching this issue very closely as the vaccine rolls 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.
Paul Offit, MD, a University of Pennsylvania vaccine expert, told the Times that fewer than one in a million recipients of other vaccines a year in the United States have an anaphylactic reaction, adding that many people with allergies to foods, bee stings or medicines have received multiple vaccines without problems.
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 three weeks 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 more vaccines get authorized for emergency use (Moderna’s is expected next and 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?
- 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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