COVID-19 Vaccines: What IBD Patients & Caregivers Need to Know
We know that you and your family probably have many questions about the COVID-19 vaccines that are being approved by the U.S. Food and Drug Administration (FDA). We are here to help and provide you with the most current information, including:
- Are COVID-19 vaccines safe?
- What does Emergency Use Authorization mean?
- How will the vaccines impact my Crohn's disease or ulcerative colitis?
- How and when will the vaccines be available?
- When will IBD patients be able to get a vaccine?
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The resources and information below reflect the questions we've received from patients and caregivers, and the latest information from unbiased and accurate sources. We will frequently update this page as new information and guidance are issued.
Vaccine approval and Emergency Use Authorization (EUA)
All vaccinations are developed and approved through a three-phase clinical trial process, similar to the phases that are used to develop, test, and approve medications. To learn more about the three trial phases, you can download our resource, Understanding the Phases of Clinical Trials, or download the graphic "The Vaccine Life Cycle" created by the Centers for Disease Control (CDC).
Like drug development, vaccine development is a long and complex process, often lasting 10-15 years.1 In the United States, the FDA provides guidance and oversight to all drugs, vaccines, and devices approved. Recognizing the urgency and need for a COVID-19 vaccine, the FDA implemented a process of reviewing and approving a vaccine under the Emergency Use Authorization (EUA). EUA2 enables the FDA to speed up the review, approval, and availability of vaccines during public health emergencies, like the COVID-19 pandemic.
Has the COVID-19 vaccine been carefully studied?
It’s important to understand that, even with the expedited approval, all COVID-19 vaccines approved went through the three phases of vaccine clinical trials. These trials included tens of thousands of individuals who have taken the vaccines. We are grateful to these clinical trial participants as they provided the data on safety, effectiveness, side-effects, and more needed to evaluate the vaccine. The FDA is undertaking a comprehensive evaluation of all information related to each COVID-19 vaccine to determine if the potential benefits outweigh any potential risks prior to approving it for use.
How does the FDA evaluate vaccines for the EUA?
The FDA is evaluating vaccine data using internal career scientists and physicians to independently review the vaccine manufacturers' data and findings. In addition to the internal review, the FDA holds public meetings of the Vaccine and Related Biologic Products Advisory Committee to discuss the vaccine.3 These meetings include external scientists and public health experts not affiliated with the FDA. After the general meeting, the FDA evaluates the data and the public hearing comments making its final recommendation – approving or not approving for emergency use. The first EUA for the COVID-19 vaccine was held on December 10 and a second one will be held on December 17.
Does the EUA mean that a vaccine is approved and clinical trials stop?
No, the FDA expects all vaccine manufacturers to implement ongoing monitoring (Phase IV of the clinical trial process) of the vaccines for deaths, hospitalizations, and serious or clinically significant adverse events among individuals receiving the vaccine. Monitoring informs the ongoing benefit-risk evaluation and whether continued use is permitted under the EUA.
Vaccine manufacturers need to continue their clinical trials beyond the EUA, providing additional safety and effectiveness data to pursue full approval once the EUA expires. The Foundation provides resources where you and your loved one can learn more about COVID-19 Clinical Trials.
Which COVID-19 vaccines received EUA approval?
See the chart below for the status of COVID-19 vaccines. We will update this section regularly as approvals and new vaccines are reviewed.
|Pfizer-BioNTech COVID-19 Vaccine||Approved||Read more|
|Moderna COVID-19 Vaccine||Approved||Read more|
It’s important that you discuss the COVID-19 vaccine with your healthcare provider before taking it. Additionally, please note that these vaccines will not be available to the general public for some time.
View the Foundation's position statement on COVID-19 vaccines to learn more.
Managing worries about the vaccine
You may be questioning whether getting the COVID-19 vaccine is right for you, including worries about how quickly it was developed. Add in a lot of conflicting information and opinions on the internet, and this can be the perfect recipe for anxiety. Here are some ways you can manage your worries as you consider the COVID-19 vaccine:
- Limit your information sources to reputable medical organizations that provide specific data and references about the vaccine, versus message boards, blogs, or other websites that may be vaguer about where information comes from
- Any hyperbolic, extreme language - either positive or negative - about the COVID-19 vaccine is probably incorrect
- If you are unsure about getting the COVID-19 vaccine, try creating a pros and cons worksheet
Discuss your worries with your IBD team. If this doesn’t help with your anxiety, you may want to meet with a counselor or therapist. With the pandemic, many therapists are now seeing people via telemedicine, considerably opening access to services. You can see any therapist in your home state.As more data and information is released about the vaccines, including information relevant to the IBD community, we will continue to update our patients and health care professionals.
Last updated December 21, 2020