The U.S. Food and Drug Administration approved two vaccines for COVID-19 under its Emergency Use Authorization process. Many patients with Inflammatory Bowel Disease may be wondering if the COVID-19 vaccines are right for them. Here, we answer 20 common questions about the vaccine and vaccination with IBD, based on an informational video from the Crohn’s and Colitis Foundation, featuring the following medical experts:

• David Rubin, MD, chief of gastroenterology, hepatology and nutrition, co-director of the Digestive Diseases Center, UChicago Medicine
• Jami Kinnucan, MD, gastroenterologist, assistant professor, Michigan Medicine

Disclaimer: This is educational information only. It should not replace the medical care you are receiving from your physician. Additional concerns should be discussed with your healthcare provider.

GENERAL INFORMATION

1. How was the vaccine developed so quickly?
The two vaccines available today, developed by Pfizer and Moderna, are Messenger RNA vaccines (mRNA). The mRNA technology has been in development for a long time. Scientists began developing an mRNA vaccine for the first SARS-CoV outbreak in the early 2000s, and the target of that vaccine is the same as that of the vaccine for the current coronavirus, SARS-CoV2. The technology works as follows: The mRNA prompts cells to create harmless spike proteins similar to those on the surface of the virus. This helps the immune system learn to recognize the spike protein and develop an immune response. It has no effect on DNA or the nucleus of the cell, and the mRNA degrades quickly in the body. Development of this vaccine went quickly during this pandemic due to the financial support provided by the government, which enabled manufacturers to begin production while large trials were underway. Standards for safety and efficacy were not changed.

2. Is there a difference between the Pfizer and Moderna vaccines?
Both vaccines are mRNA vaccines and have similar efficacy and safety.

3. Can these vaccines transmit the virus?
These vaccines do not contain any live virus. They therefore cannot transmit the virus.

4. What does emergency approval mean and when will these vaccines receive full FDA approval?
The emergency use authorization is a status that the FDA can use during an emergency, when the benefits far outweigh the risks. The vaccine trials included 30,000 to 40,000 patients. Long-term follow-up trials for full FDA approval last two years, which Dr. Rubin believes is longer than necessary to compare the benefits and risks.

5. Have the companies cut any corners that will affect the safety of the vaccines?
Drs. Rubin and Kinnucan believe standard processes for safety and efficacy were followed in the production of these vaccines, and we are quite comfortable with the results so far. Both the Pfizer and Moderna studies included 30,000 to 40,000 patients, which is three to four times what is usually used in these studies. The annual flu vaccine is developed with just 10,000 patients.

INFLAMMATORY BOWEL DISEASE (IBD) and VACCINATION

6. What are the safety concerns for people who have suppressed immune systems?
Patients with IBD have overactive immune systems and are not immunosuppressed, even by the therapy. There are no safety concerns for IBD patients, but the vaccines could be less effective. The Crohn’s and Colitis Foundation, along with IBD Partners, plans to track the effectiveness in IBD patients in the coming months.

The only drugs that Drs. Rubin and Kinnucan are concerned about are steroids, which do suppress your immune system. If you take over 20mg of prednisone or if you are on combination therapy with a thiopurine (Methotrexate, Imuran or 6MP), you may have a blunted response to the vaccine. You should discuss this with your physician.

7. What about patients with ostomies, J pouches or recent surgeries?
There is no specific worry for patients with ostomies, J pouches or recent surgeries.

8. Can the vaccine trigger an exacerbation of your IBD?
Significant research has been conducted on vaccines and IBD. Vaccines do not appear to exacerbate IBD. You should not expect your IBD to get worse after the vaccine.

9. What is the potential for the vaccine to cause a disease flare?
No other vaccine has activated or exacerbated IBD to date. We do not expect this vaccine will be any different.

10. Are IBD patients at increased risk of getting severe COVID-19?
IBD has not been associated with an increased or decreased risk for severe COVID-19. IBD patients should get the vaccine when it’s available to them.

11. What should patients know about their IBD medications and the vaccine?
Drs. Rubin and Kinnucan believe that all IBD medications, even steroids, are safe with the vaccine. Some IBD medications could blunt the response to the vaccine. We know steroids and thiopurines may blunt the response of other vaccines. The Crohn’s and Colitis Foundation, along with IBD Partners, plans to track the effectiveness in IBD patients in the coming months.

WHO SHOULD BE VACCINATED

12. If you had coronavirus do you need the vaccine?
Yes. The vaccine can help develop greater immunity, even if you had COVID-19.

13. If you have IBD and tested positive for COVID-19 in the past, should you receive the vaccine?
Yes, you should receive the vaccine. If you have just been diagnosed with COVID-19, or if you have been recently exposed to COVID-19, you should defer the vaccine until your quarantine or active COVID-19 period is over.

14. If you’ve recently had another vaccine, should you get the COVID-19 vaccine?
The recommendation is to spread the vaccines out. Therefore, if you have not received your flu vaccine, the recommendation is to get this vaccine as soon as possible, so you are ready to get the COVID-19 vaccine when it becomes available.

15. Should your non-IBD family members living in the house with you receive the vaccine?
Yes, they should be vaccinated.

WHAT TO EXPECT POST-VACCINATION

16. What are the expected side effects of the vaccines?
These vaccines are designed to be “reactogenic,” so we do expect a response. Typical side effects are related to the injection itself, and may include soreness, redness and muscle aches at the injection site. Fever, headache and muscle aches can also develop and last for 24-72 hours, especially after the second dose.

17. What about the allergic reactions to the vaccine?
Patients who have had allergic reactions to vaccinations or IBD therapies, like colonoscopy preps, or who have experienced anaphylaxis should take special precautions. In extremely rare instances, patients have experienced allergic reactions to the polyethylene glycol the vaccine contains. If you have food allergies, you should not necessarily expect an allergic reaction to the vaccine.

18. How long does it take to develop immunity to the vaccines?
Drs. Rubin and Kinnucan believe the greatest effect of the vaccine is after the second (booster) dose, which is over 90% effective. The first primer dose appears to provide 50% effectiveness in fighting off the disease.

19. How long will the immunity last?
The mRNA of the vaccine has a short half-life. It does not stay in your body long, but the immune response to it does.

20. Do you need to socially distance after you get the vaccine?
Yes. The vaccine and the immunity you derive from it protect you from severe symptoms of COVID-19, but we don’t know if the vaccine keeps you from getting, carrying and transmitting the virus. Because we don’t know if the vaccine decreases your chance of transmission, it is crucial to continue social distancing. Remember, there is an asymptomatic carrier state with this virus.