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.

The Pfizer vaccine is the only fully-approved COVID-19 vaccine, for the prevention of COVID-19 disease in individuals 16 years of age and older. The Pfizer vaccine also continues to be available under EUA, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. The Moderna and Johnson & Johnson vaccines are authorized under EUA, and for people who are 18 and over. 

Women under 50 years are cautioned to be aware of the potential for a very rare but serious side effect associated with the Johnson & Johnson vaccine called thrombocytopenia syndrome (TTS). 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. More information 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 for the Moderna and Johnson & Johnson vaccines 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.

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.

Adolescents ages 12 to 15, who are now allowed to receive the Pfizer vaccine, experienced side effects that are consistent with ones reported for participants 16 years old and older.

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. As of April 23, The CDC and FDA have lifted the pause on the Johnson & Johnson vaccine after reviewing the evidence and finding the benefits of this vaccine outweigh the risks. Women under 50 are cautioned to be aware of the potential for a very rare but serious side effect called thrombocytopenia syndrome (TTS). 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.

The CDC and FDA will continue to monitor the safety of all COVID-19 vaccines.

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. Your doctor may also recommend that you continue to wear a mask or social distance as much as possible even after becoming fully vaccinated. 

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 and recent research, 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. 

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.

The CDC recommends the COVID-19 vaccine for everyone 12 years and older, including those who are pregnant or breastfeeding. People who are pregnant or have recently been pregnant are at higher risk of severe illness from COVID-19 than those who are not or have not recently been pregnant. If you are pregnant and have lupus, talk with your doctor about getting the COVID-19 vaccine. 

The Pfizer vaccine is authorized for people 12 and older. In May 2021, Pfizer received an extension of the emergency use authorization for its vaccine to children ages 12 to 15. The Moderna vaccine is authorized for those 18 and older. The Johnson & Johnson vaccine is also authorized for those 18 and older. It has been noted that women under 50 should be advised of the potential for a very rare but serious side effect called thrombocytopenia syndrome (TTS). 

The vaccines are widely available in every state from local health departments, hospitals and clinics, and retail pharmacies. The vaccine is free to everyone even if they don’t have health insurance and regardless of immigration status. Find a convenient place to get 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.

You may not be able to stop wearing a mask and go back to your normal activities even after you have been vaccinated. Some people with lupus may not have a strong response to the vaccine and may not produce enough protective antibodies. In addition, the virus has changed and may be easier to catch and transmit even if you are vaccinated. Researchers are currently studying how people with lupus respond to the vaccine but there are no complete answers to this question yet. Because of this, the CDC advises that people who have weakened immune systems should continue to wear masks and practice social distancing indoors. 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. 

The FDA has amended the Emergency Use Authorization (EUA) for the Pfizer and Moderna vaccines to allow for a third dose of the COVID-19 vaccine to be given to people who have  compromised immune systems. The third dose (also called a booster shot) is intended to increase the level of antibodies against the virus that causes COVID-19 in these individuals. It should be given at least 28 days after receiving the second dose of the Pfizer or Moderna vaccine. 

The CDC has recommended the additional dose for people who are moderately or severely immunocompromised, such as organ transplant recipients (for example, people who have received a kidney transplant). Although some people with lupus may not have a strong response to the vaccine, many people with lupus are not immunocompromised to this degree and will not need a third dose at this time. Some powerful immunosuppressant medications, such as Rituximab or high doses of steroids, may cause the vaccine to be less effective. If you are taking this type of medication, you should talk to your doctor about whether you should get a third dose of the vaccine.

If your doctor advises that you receive a third dose of the vaccine you should try to get the same vaccine as your first 2 shots. If you received the Pfizer vaccine, your third dose should also be Pfizer. If you received the Moderna vaccine, your third dose should also be Moderna. You can receive another mRNA vaccine, however, if the vaccine that you received for your first 2 doses is unavailable.

There is not enough evidence at this time to recommend a follow up mRNA vaccine dose for people who received the Johnson & Johnson vaccine. The FDA and CDC are working to update the guidance for people who received the Johnson & Johnson vaccine. 

Researchers are currently studying how people with lupus respond to the vaccine but there are no complete answers to this question yet. Because of this, the CDC advises that people who have weakened immune systems should continue to wear masks and practice social distancing indoors even after they are vaccinated. You should talk to your health care team about whether it is safe for you to stop wearing a mask and taking other precautions even after you are vaccinated.