COVID-19 Vaccines: Position Statements

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COVID-19 Vaccines | COVID-19 Vaccine Additional Dose

The Crohn’s & Colitis Foundation advocates on behalf of the millions of Americans who are affected by Crohn’s disease and ulcerative colitis, collectively known as inflammatory bowel disease (IBD).

The Foundation supports the principles below as they relate to the IBD community and the safety, efficacy, and delivery of COVID-19 vaccines:

Now that COVID-19 vaccinations are widely available, the Foundation supports eligible IBD patients getting vaccinated.

The Foundation supports access to safe and effective vaccinations for COVID-19.

IBD patients are not at increased risk of severe illness from the coronavirus^1,2,3,4

Most patients with IBD are not considered immune suppressed and therefore should not need an additional dose of mRNA vaccine. Please see COVID-19 Vaccine Additional Dose Position statement for additional details.

The Foundation remains committed to monitoring information as it is made available regarding the status of COVID-19 vaccines and their impact on IBD patients.

The Foundation continues to support and encourage social distancing, mask wearing, and other strategies designed to mitigate the spread of the coronavirus.

There have been no recommendations from the FDA or CDC regarding the Johnson & Johnson vaccine. We will continue to update as additional information becomes available.

The CDC and ACIP do not recommend checking antibody levels currently.

COVID-19 Vaccine Safety and Effectiveness

All vaccines are developed and approved through a rigorous method, like the clinical trial phases that are used to develop, test, and approve medications. The U.S. Food and Drug Administration (FDA) provides guidance and oversight of all drugs, vaccines, and devices used in the United States. Recognizing the urgency and need for a COVID-19 vaccine, the FDA implemented an expedited process of reviewing and approving a vaccine under an Emergency Use Authorization (EUA)⁵. The FDA is now reviewing one of the COVID-19 vaccines for full approval. The Foundation will continue to update the community of full approvals and additional EUAs.

In the development phase, COVID-19 vaccines must go through the three phases of vaccine clinical trials during which time tens of thousands of individuals receive the vaccines. For an EUA to be issued for a vaccine, the FDA performs a comprehensive evaluation of all available information related to each vaccine and determines that the known and potential benefits outweigh the known and potential risks of the vaccine. This EUA evaluation is performed by a team of career scientists and physicians within the FDA and includes a review from external scientists and public health experts not affiliated with the FDA. Importantly, no steps in FDA’s review process were skipped for the COVID-19 vaccines currently under the EUA.

The currently approved vaccines do not contain live virus particles. There is no concern of contracting COVID-19 from such non-live vaccines, even among patients on their immune therapies. Non-live vaccines are considered safe for IBD patients regardless of the type of IBD therapy the patient is receiving. Patients with IBD can mount normal immune response to vaccines.

Those on certain immune-modifying treatments, such as anti-TNF biologics, may have a reduced immune response to certain vaccines, but not necessarily all vaccines.⁶ We know those on azathioprine therapy have been shown to have a normal vaccine response. However, vaccination should not be deferred solely because they are receiving those treatments. IBD patients receiving systemic corticosteroids should be advised by their healthcare team on potential decreased vaccine efficacy.⁷ Studies evaluating immune response of COVID-19 vaccines in solid organ transplant recipients have shown not all patients achieve an immune response (see COVID-19 Vaccine Additional dose guidance). In contrast, the CORALE-IBD, ICARUS Study, and the PREVENT COVID have all shown IBD patients who received both doses of the mRNA vaccine mounted an immune response. More information on the studies is summarized on our IBDVisible blog.

In addition, the approved vaccines are also considered safe and have been recommended by the CDC⁸ and the American College of Obstetricians and Gynecologists⁹ for women with IBD that are planning pregnancy, are pregnant, or are currently lactating.²

Considerations for Receiving a Vaccine

Now that COVID-19 vaccinations are widely available, the Foundation supports eligible IBD patients getting vaccinated.

The decision to be vaccinated should be a partnership between a patient with IBD and their healthcare team. This partnership includes addressing any concerns to help make an informed decision on receiving a vaccine. The Foundation seeks to inform the community with the best available information; however, decisions on vaccinations must be made on an individual basis between a patient and their provider. The Foundation continues to monitor the status of current and future COVID-19 vaccines, including their impact on the IBD community.

Consideration for IBD Patients of Color

There is increasing evidence that COVID-19 disproportionately impacts Black, Latino, and Native American communities in the U.S., and that these communities are experiencing higher rates of infection, hospitalizations, and deaths due to COVID-19.^7,8 Socioeconomic factors, lack of access, systemic inequities, biases, and racism play a role in exacerbating the impact of the pandemic in these communities as well as other groups across the country. More studies are needed to further understand this impact, particularly among patients with Crohn's disease and ulcerative colitis.

More Information

Patients and providers can find the latest COVID-19 vaccine information by visiting the Foundation’s vaccine resources webpage. Individual inquiries can be addressed to the Irwin M. and Suzanne R. Rosenthal IBD Resource Center (IBD Help Center), Monday through Friday, 9:00 a.m. to 5:00 p.m. ET at 888-MY-GUT-PAIN (888-694-8872) or [email protected].

References

1 Allocca, M., Chaparro, M., Gonzalez, H. A., Bosca-Watts, M. M., Palmela, C., D’Amico, F., . . . Fiorino, G. (2020). Patients with Inflammatory Bowel Disease Are Not at Increased Risk of COVID-19: A Large Multinational Cohort Study. Journal of Clinical Medicine, 9(11), 3533. doi:10.3390/jcm9113533

2 Brenner, E. J., Ungaro, R. C., Gearry, R. B., Kaplan, G. G., Kissous-Hunt, M., Lewis, J. D., . . . Kappelman, M. D. (2020). Corticosteroids, But Not TNF Antagonists, Are Associated With Adverse COVID-19 Outcomes in Patients With Inflammatory Bowel Diseases: Results From an International Registry. Gastroenterology, 159(2). doi:10.1053/j.gastro.2020.05.032

3 Derikx, L. A., Lantinga, M. A., Jong, D. J., Dop, W. A., Creemers, R. H., Römkens, T. E., . . . Hoentjen, F. (2020). Clinical Outcomes of Covid-19 in Patients With Inflammatory Bowel Disease: A Nationwide Cohort Study. Journal of Crohn's and Colitis. doi:10.1093/ecco-jcc/jjaa215

4 Papa, A., Gasbarrini, A., & Tursi, A. (2020). Epidemiology and the Impact of Therapies on the Outcome of COVID-19 in Patients With Inflammatory Bowel Disease. American Journal of Gastroenterology, 115(10), 1722-1724. doi:10.14309/ajg.0000000000000830

5 United States, Food and Drug Administration. (2020, November 20). Emergency Use Authorization for Vaccines Explained. Retrieved from https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

6 Normal Response to Vaccines in Inflammatory Bowel Disease Patients Treated with Thiopurines, Iris Dotan, MD,^*† Lael Werner, PhD,^*† Sharon Vigodman, PhD,^*† Shradha Agarwal, MD,^‡ Jorge Pfeffer, MD,^* Noya Horowitz, PhD,^* Lisa Malter, MD,^§ Maria Abreu, MD,^§ Thomas Ullman, MD,^§ Hanan Guzner-Gur, MD,^† Zamir Halpern, MD,^* and Lloyd Mayer, MD^‡§,Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3919517/

7 United States, Food and Drug Administration. (2020, November 20). Emergency Use Authorization for Vaccines Explained. Retrieved from https://www.fda.gov/vaccines-b

8 New CDC data: COVID-19 Vaccination Safe for Pregnant People. Retrieved from https://www.cdc.gov/media/releases/2021/s0811-vaccine-safe-pregnant.html

9 COVID-19 Vaccination Considerations for Obstetric-Gynecologic Care. Retrieved from https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/covid-19-vaccination-considerations-for-obstetric-gynecologic-care

The information shared in this position statement is meant for educational purposes only. It should not replace the advice or care provided by your healthcare team.

View and download the position statement as a PDF

Last updated August 18, 2021

COVID-19 Vaccine Additional Dose

The Foundation supports the principles below as they relate to the IBD community and the safety, efficacy, and delivery of an additional dose of the COVID-19 vaccine:

The Foundation supports access to safe and effective vaccinations for COVID-19.

IBD patients are not at increased risk of severe illness from the coronavirus^1,2,3,4

COVID-19 vaccinations are widely available, and the Foundation supports eligible IBD patients getting vaccinated. Please see COVID-19 Vaccine statement for additional details

Most patients with IBD are not considered immunosuppressed and therefore should not need an additional COVID-19 vaccine.
- From the beginning of the pandemic, the overall data about IBD patient’s COVID-19 risk has been reassuring. For additional insight see COVID-19 Vaccine statement and Vaccine Monitoring

On August 13, 2021, the Advisory Committee on Immunization Practices (ACIP) recommended an additional dose of mRNA COVID-19 vaccine for moderate to severe immunocompromised individuals and to individuals on the following therapies.
- High-dose corticosteroids (defined at ≥20mg / day of oral prednisone)
- Anti-TNF biologics and biosimilars
- Immunomodulators (azathioprine, methotrexate, etc.)

The ACIP’s recommendation was based on available evidence about solid organ transplant patients and extrapolated for others who may have similar levels of immunosuppression.⁵ It’s important to recognize that current studies suggest that most patients with IBD can produce an immune response to the vaccination, unlike solid organ transplant recipients.
- Patients interested in receiving an additional dose of the vaccine should get the same mRNA vaccine as their initial two doses (Pfizer or Moderna). In other words, if you got Pfizer your third shot should be the Pfizer vaccine, if you got Moderna, the third dose should be Moderna. *Please note, booster shots should take place at least 28 days after your second dose of Pfizer or Moderna
- Individuals wishing to get an additional dose do not need a doctor’s order or verification to receive the additional dose.

ACIP and the CDC did not make specific recommendations on other biologics (vedolizumab, ustekinumab),5-ASAs, thiopurines, and the disease modifying small molecules (tofacitinib and ozanimod). Patients and providers are encouraged to discuss the merits of receiving an additional dose of COVID-19 vaccine. As additional evidence and guidance is available the Foundation will provide updates. If you have questions about your IBD treatments, please visit: medication recommendations

Currently, there are no recommendations from the FDA or CDC regarding an additional dose of the Johnson & Johnson vaccine. We will update when more information becomes available.

The Foundation encourages additional research on the impact of the COVID-19 vaccine and remains committed to monitoring information as it is made available regarding the status of COVID-19 vaccines and their impact on IBD patients.

The Foundation continues to support and encourage social distancing, mask wearing, and other strategies designed to mitigate the spread of the coronavirus.
- CDC/ACIP strongly recommend everyone continue to wear masks and maintain social distancing to help control the spread of disease.

The Foundation does not recommend serologic testing or cellular immune testing to determine immune (antibody) response to vaccination; data establishing the effectiveness of these tests have not been established. These tests are only currently recommended in the setting of a research study.

Providing an Additional mRNA Vaccine Dose

On August 12, 2021, FDA amended their EUA to allow for the use of an additional dose of the COVID-19 mRNA vaccines in certain immunocompromised individuals, specifically solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

Based on this amendment by the FDA the ACIP, advised the CDC on how to use additional doses of the mRNA vaccines.⁶This committee considered the available evidence supporting the use of an additional mRNA dose and then recommended which conditions or disease qualify for an additional mRNA dose. The ACIP is not able to provide recommendation for every disease state. Because evidence suggests that certain organ transplant recipients do not mount an immune response after completing a two-dose series, the ACIP recommended that moderate to severely immunocompromised should complete a three-dose series. The ACIP went as far as to recommend individuals on certain medications, including high-dose corticosteroids (defined at ≥20mg / day of oral prednisone), Anti-TNF biologics and biosimilars, Immunomodulators (azathioprine, methotrexate, etc.) receive a third dose.

The Foundation is aware of the FDA and CDC updates and supportive of patients with IBD getting an additional dose if they are on immune therapies. We also want to reassure the IBD population that the available data at this time from multiple studies show the vast majority of patients are able to mount an immune response post immunization and do not show that our patients who are vaccinated are at increased risk of infection or hospitalization. Current data shows that IBD patients are not inherently at increased risk for severe illness from the COVID-19.^2,3,4,5,6The CORALE-IBD, ICARUS, and PREVENT COVID studies have all published data in peer reviewed journals demonstrating that IBD patients mount an immune response to the vaccine.⁷

We anticipate that similar to all patients with IBD needing a yearly influenza vaccine boosters, it’s highly likely that all patients with IBD will need a COVID-19 booster when its recommended for the general population even those who are not on immune therapies. For more information on maintaining good health and annual vaccinations please visit: Health Maintenance Checklists

The Foundation encourages patients with IBD to continue to follow practices that mitigate the spread of the coronavirus as recommended by the CDC, including wearing masks. The Foundation will provide updates on additional doses and booster shots of COVID-19 vaccine as guidance is provided by the CDC.

Mixing vaccination doses for boosters

The FDA has updated its approvals of the COVD-19 vaccines to allow for a "mix and match" approach to booster doses. People who had received the Johnson & Johnson vaccine may receive a booster dose from the other available vaccines, such as a dose of the Pfizer vaccine, and a half dose of the Moderna vaccine. Patients who receive the initial series of the mRNA vaccines may decide to have a booster dose of another (again, with Moderna being a half dose), including Johnson & Johnson. More information can be found in the following FDA update.

More Information

References

5 Retrieved from:https://www-sciencedirect-com.proxy.library.upenn.edu/science/article/pii/S0016508521031279

6 Centers for Disease Control and Prevention, Vaccine Recommendations and Guidelines of the ACIP, Retrieved from https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html

7 Updates on COVID-19 vaccine research in patient with IBD. Retrieved from https://www.crohnscolitisfoundation.org/blog/updates-covid-19-vaccine-research-patients-with-ibd

The information shared in this position statement is meant for educational purposes only. It should not replace the advice or care provided by your healthcare team.

View and download the position statement as a PDF

Last updated October 21, 2021