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. The Foundation will support research on the COVID-19 vaccines in the IBD community through IBD Partners, our patient-powered research network. IBD Partners is launching an online study of IBD patients who receive the COVID-19 vaccine to gain insights on IBD disease course, side effects, and vaccine effectiveness through surveys and optional blood draws.  We encourage all patients receiving the vaccine to sign-up and contribute their data so that we can learn as much as possible. Please visit the IBD Partners site – www.IBDPartners.org – to register and learn more about our ongoing patient-reported research initiatives.

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.

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