COVID-19 Vaccine Monitoring

You may be concerned about the safety of the COVID-19 vaccines and how they are monitored after EUA approval. To learn about the FDA vaccine review and approval, please visit our resources on emergency use authorization. Below, we’ll provide additional insights into the on-going monitoring of the COVID-19 vaccines.

Why is it important to monitor these vaccines?  

The COVID-19 vaccine trials included tens of thousands of people before the vaccines received FDA approval; however, the initial randomized controlled trials of the COVID-19 vaccines did not have a significant number of IBD patients or patients with other immune mediated diseases or conditions. The first study of a new vaccine often focuses on a broader sample of the general population to answer general safety and efficacy questions before understanding the effects in special populations, like those with Crohn’s disease or ulcerative colitis.

As the vaccine is distributed to those with IBD, it will be essential to collect data to share with the broader IBD population on the efficacy and the safety of the vaccine. If you have IBD and have received a COVID-19 vaccine, you may be able to take part in PREVENT COVID, a research study brought to you by IBD Partners to learn more about how well the COVID-19 vaccine works for IBD patients. 

IBD Partners is also working with other immune mediated disease populations, such as rheumatoid arthritis and multiple sclerosis, to understand COVID-19 vaccine data in the broader community.

Researchers at Cedars-Sinai are looking for adults with IBD who are planning to receive, or who have already received, a COVID-19 vaccine for a research study. The CORALE-IBD Study, seeks to understand the safety and effectiveness of vaccination, as well as perceptions around vaccination and overall well-being related to the COVID-19 pandemic.

Video Length 00:37:02

COVID-19 Vaccine Research Opportunities for IBD Patients In this video, we discuss two active studies – PREVENT COVID and CORALE – with Drs. Millie Long (University of North Carolina) and Gil Melmed (Cedars-Sinai) and why it’s important for patients to enroll in them.

To learn more about clinical trials and other COVID-19 research studies, visit: https://www.crohnscolitisfoundation.org/coronavirus/clinical-trials 

Antibodies and COVID-19 Vaccines

After infection from SARS-CoV-2, the body’s immune system responds by producing antibodies which can recognize and help protect people from the virus. It is uncertain how long these natural antibodies may last in the body.  Some studies suggest that immunity from natural infection (natural infection meaning, having contracted the infection from an exposure), may be less effective at protecting the body from infection than vaccine-induced immunity.1

Though antibody tests are available for SARS-CoV-2, some tests evaluate for antibodies from previous infection rather than antibodies induces by vaccines.   Furthermore, it is not known whether these tests offer accurate information regarding immunity, since a correlate of immunity has not been established.  It is not recommended to use commercial antibody test to determine if you are immune against COVID-19.  Antibody test results do not lessen the importance of social distancing or use of face masks.

Though more research is underway, vaccines continue to the be best way for people including those with IBD, to decrease their risk of infection, serious illness or death from COVID-19. Therefore, it is recommended that IBD patients obtain the vaccine even if they have already had the SARS-CoV-2 virus.2

Whether certain immunosuppressive medications may impact the COVID-19 vaccine is not fully known. One recent study of the COVID-19 mRNA vaccines in IBD patients suggests that all of those who received mRNA vaccines had appropriate and expected antibody responses, most being patients receiving biological therapies (including anti-TNF medications).3

Vaccines are an important way for patients with IBD to be protected from infection, so talk to your doctor about your concerns, schedule your vaccination, and consider taking part in research!

Resources:

References:

1. K. Florian. Correlates of Protection from SARS-Cov-2 Infection. Volume 397, Issue 10283, P1421-1423, April 17, 2021

2. D.T. Rubin. Tweetorial to Clarify the NYT Article from 15 April and Further Explain/Clarify the UK CLARITY IBD Study. Rubin Lab (uchicago.edu)

3. S. Wong., R. Dixon, V. Martinez Pazos, ICARUS-IBD Working Group. Sacha Gnjatic. J.F. Colombel, K. Cadwell. Serological Response to COVID-19 vaccination in IBD patients receiving biologics. https://doi.org/10.1101/2021.03.17.21253848