COVID-19 vaccine and lupus

The U.S. Food and Drug Administration (FDA) has approved an Emergency Use Authorization (EUA) for two 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) and ModernaTX, Inc. (Moderna). 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 FDA is responsible for authorizing and approving all vaccines in the U.S. and Pfizer and Moderna are the first two companies to have vaccines approved. AstraZeneca also has a leading vaccine candidate but has not applied for approval yet, and several other companies are working to develop vaccines. 

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.

Even with the EUA, the vaccines may not be available to most people until spring or summer of 2021. Because of the limited supply of the vaccines, people at very 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.

Neither the Pfizer vaccine nor the Moderna vaccine contain live virus. Both vaccines use a new technology that relies on messenger RNA (mRNA) from the virus to teach the body how to respond to COVID-19 exposure.

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.

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 if you are concerned 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 that people with lupus should not receive the vaccine. According to the CDC, there is no reason to think that taking the vaccine will result in an inflammatory response (flare) for a person with lupus or other autoimmune disease. 

There is strong evidence from the clinical trials, however, that taking the vaccine greatly reduces the chance that a person will get COVID-19, which can be a serious or even fatal illness. 

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 are 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 vaccine 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 while the Moderna vaccine is authorized for those 18 and older. Pfizer has begun including children as young as 12 in their COVID-19 vaccine clinical trials and there are plans to include more in future trials. It may take some time, however, for the vaccine to be recommended for children because it will need to be studied carefully for safety and effectiveness.

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 deciding on high priority groups and 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. 

Unfortunately, we may not be able to go “back to normal” for some time. The vaccine is important but even after both doses it will take several weeks to be fully effective. It will also take time for enough people to get vaccinated to stop the spread of COVID-19 in your community. 

Even after you have received the vaccine, it is crucial 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 either of the vaccines that are currently available.

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.