COVID-19 vaccine and lupus

The U.S. Food and Drug Administration (FDA) has approved an Emergency Use Authorization (EUA) for three vaccines to prevent COVID-19 (the illness caused by SARS-CoV-2, a type of coronavirus). The vaccines were developed and manufactured by Pfizer, Inc (Pfizer), ModernaTX, Inc. (Moderna), and Janssen Biotech, Inc., a company owned by Johnson & Johnson (Johnson & Johnson). The Pfizer vaccine is given in two doses at least three weeks apart and the Moderna vaccine is given in two doses at least one month apart. You must receive both doses to get the full benefit from the vaccine. The Johnson & Johnson vaccine is given in only one dose.

Recently, the CDC and the FDA have recommended a pause on the Johnson & Johnson vaccine due to rare, but severe, side effects. The Advisory Committee for Immunizations Practices will review and meet about the Johnson and Johnson vaccine on April 23, 2021. More information and updates on the Johnson & Johnson vaccine can be found on the CDC website.

An EUA is not a full approval of the vaccine, although it does allow for the vaccine to be distributed and used. The EUAs will remain in effect for as long as the COVID-19 pandemic is declared an emergency or until the vaccines receive full approval from the FDA. The FDA will continue to review safety and effectiveness data for all COVID-19 vaccines that are in use or waiting for authorization.

Because of the limited supply of the vaccines, people at high risk, such as health care providers and people who live in nursing homes or assisted living facilities, will get a vaccine before people whose risk of illness is lower. Many states have rolled out an online system to see when and if someone is eligible to receive a vaccine. Please check with your local government's coronavirus information page for updates.

The Pfizer vaccine and the Moderna vaccine use a new technology that relies on messenger RNA (mRNA) from the virus to teach the body how to protect against COVID-19. 

The Janssen vaccine uses a harmless virus (NOT the virus that causes COVID-19) to deliver a type of protein from SARS-CoV-2 (the virus that causes COVID-19) to the immune system that teaches it to recognize and fight COVID-19. The harmless virus used for the vaccine cannot give you COVID-19.  

Other vaccines that are under development may use different ways to protect the body from the virus that causes COVID-19. We will know more about how those vaccines work as the companies release more information.

Vaccines are studied in thousands of people before they are given to the general public. It isn’t possible, however, to study each vaccine in every type of person before it is approved. The FDA, the Centers for Disease Control and Prevention (CDC), and the companies that make the vaccines will continue to study their safety and effectiveness even after they are approved. 

The following CDC vaccine pages are a great place to learn more about how COVID-19 vaccines are being developed and how they work in the body:

• Facts about COVID-19 Vaccines
• Understanding How COVID-19 Vaccines Work

No. It is not possible to get COVID-19 from any of the vaccines that have been approved or are currently being reviewed by the FDA.

Many people in the clinical trials had some short-term side effects from taking the COVID-19 vaccines. The side effects are usually not serious -- one of the most common is a sore or achy arm. Some people develop low-grade fevers or chills and feel tired. This is because the vaccine is working and causing a response from the immune system. 

The Pfizer vaccine is given in two doses three weeks apart and the Moderna vaccine is given in two doses one month apart. For both vaccines it is more common to have side effects from the second dose than the first. You must receive both doses to get the full benefit from the vaccine.

In most cases these side effects are not dangerous and will go away on their own within a short time. Please call your doctor if these side effects last for more than two days or if you have side effects that are more severe.

The Johnson & Johnson vaccine only requires one dose. At this time, the Johnson & Johnson vaccine is not being given while the CDC and FDA investigate a rare but serious potential side effect. If you have received the Johnson & Johnson vaccine and begin to experience a severe headache, abdominal pain, leg pain, or shortness of breath, you should seek medical attention right away.

In general, lupus medications will not affect how the vaccine works. In some cases, particularly for those who take powerful immunosuppressant drugs, your doctor may have special instructions for you so that you can get the greatest possible benefit from the vaccine. Please check with your doctor about how the vaccine fits into your treatment plan.

It is unlikely that many people with lupus were included in the clinical trials for the vaccines. There is no evidence, however, that people with lupus should not receive the vaccine. 

According to the CDC, there is no reason to think that taking a vaccine that uses mRNA will result in an inflammatory response (flare) for a person with lupus or other autoimmune disease. 

We still don’t have much information on the Johnson & Johnson viral vector vaccine and people with lupus. But there is no reason to think that it will not be safe for people with lupus to receive it once the pause has been lifted.

There is strong evidence from the clinical trials that taking the vaccine greatly reduces the chance that a person will get COVID-19, which can be a serious or sometimes fatal illness. There are a number of studies underway on how COVID-19 and the vaccines affect people with lupus.  

The American College of Rheumatology COVID-19 Vaccine Clinical Guidance recommends that people with autoimmune and inflammatory rheumatic disease (which includes lupus) get the vaccine unless they have an allergy to an ingredient in the vaccine.  We will have more information as more research studies are conducted and analyzed over time. We recommend talking with your health care team about the vaccines and your treatment plan, since it can vary from person to person. 

Additionally, please continue to follow our Coronavirus and Lupus page for more updates as information is made available.

There is not yet any data on the safety and effectiveness of any of the current COVID-19 vaccines being studied for women who are pregnant or breastfeeding. However, due to the overall safety of the vaccines and the known risks of COVID-19, the CDC recommends that pregnant women should receive the vaccine if they are in another high priority group. If you are pregnant and have lupus, please talk with your doctor about the possible risks and benefits of a COVID-19 vaccine. 

The Pfizer vaccine is authorized for people 16 and older. In April 2021, Pfizer requested to extend the emergency use authorization for its vaccine on children ages 12 to 15. The FDA is currently assessing the evidence. The Moderna vaccine is authorized for those 18 and older. The Johnson & Johnson vaccine has been paused by the CDC due to rare, but severe side effects.

The CDC has an Advisory Committee on Immunization Practices (ACIP) that makes recommendations on who should receive the vaccine when there is a limited supply. ACIP has recommended that health care providers and people who live in nursing homes or assisted living facilities receive the vaccine before others. Those at high risk for severe COVID-19 illness due to underlying medical conditions, people aged 65 years and older, and essential workers may also be given priority. 

Each state will consider the CDC recommendations when coming up with its own plan. The states don’t have to follow the recommendations, however, and every state will have a different approach. 

Many states are still  updating plans based on new information, vaccine supply or distribution issues, and other factors. Please check with your state health department for the latest information for where you live. 

You can also check out this resource from the National Academy for State Health Policy to learn more about states’ approaches and updates to their vaccine distribution.

It may be spring or summer of 2021 before a vaccine becomes available to you, your family, or caregivers. It is important that you continue to stay home when you can, wear a mask when you go out, physically distance from people outside of your household, and wash your hands frequently. You should do these things both before and after you receive the vaccine.

You will not  be fully vaccinated until 2 weeks after the second dose of a two-dose vaccine or 2 weeks after you receive a one-dose vaccine.

While the CDC has advised that fully vaccinated people may be able to resume some activities, it is important to remember that people with lupus are at higher risk for severe illness and that every person with lupus is different. You should talk to your health care team about when it is safe for you to stop wearing a mask or return to attending public events even after you have been fully vaccinated.

Your health care team may advise that you continue to follow these recommendations to protect yourself and your family: 

• Stay at home as much as you can. Avoid high-risk activities such as travel, indoor gatherings with people outside of your household, and large gatherings even if they are outdoors.
• When you do go out, wear a mask, avoid crowds, wash your hands often, and sanitize surfaces.
• Stay in touch with your health care team and continue to follow your lupus treatment plan.

Take care of your mental and emotional health.

According to the American College of Rheumatology patients with lupus and other autoimmune inflammatory and rheumatic disease should receive whichever vaccine is available. There is no clinical reason to prefer any of the vaccines that are currently available.

If you receive a two-dose vaccine, both doses should be made by the same company. If your first dose of the vaccine is made by Pfizer, your second dose should also be made by Pfizer. If your first dose is made by Moderna, your second dose should also be made by Moderna.

If you receive the Johnson & Johnson vaccine, you will not need a second dose.

According to the CDC, early evidence suggests that natural immunity (the immunity that someone gains from having an illness and getting better) may not last very long in the case of COVID-19. More studies are underway in an effort to understand this better.

In general, you should get the vaccine even if you have already had COVID-19. However, you may need to wait for some time after recovering from the virus before taking the vaccine. Please talk to your doctor about when you should get the vaccine if you have already had COVID-19.