COVID-19 Vaccine in the Pediatric Population
If you have a child with inflammatory bowel disease (IBD), you’re probably wondering if the COVID-19 vaccine will be safe for them to take. Most clinical trials of COVID-19 vaccinations to date have not included pediatric patients. Generally, clinical trials start with older age groups and progress downward. The U.S. Food and Drug Administration (FDA) has recently granted Emergency Use Authorization (EUA) of a vaccine in the pediatric population (see chart below). Clinical trials are ongoing for vaccine use in children and adolescents.
These are the COVID-19 vaccine trials and EUA status that currently includes children and adolescents:
|Company||Emergency Use Authorization||Age Group|
|Fully approved by the FDA||
expanded to ages 6 months to 4 years and ages 5 to 11
expanded to ages 6 months to 5 years and ages 6 to 11
|Jannsen /Johnson & Johnson||Authorized||18+|
Is the COVID-19 vaccine safe for children?
COVID-19 vaccines can be administered to patients with underlying health conditions, including inflammatory bowel disease. As of May 10, 2021, the FDA expanded the emergency use authorization for the Pfizer- BioNTech COVID-19 vaccine to include adolescents 12 through 15 years old. You should discuss any risks or contraindications (such as known serious allergic reactions to other types of vaccines) with your child’s doctor. Note: the COVID-19 vaccines currently in use within the U.S. are inactivated.
The COVID-19 vaccines are mRNA vaccines, and are being held to the same rigorous safety and effectiveness as all other types of vaccines in the United States. The only COVID-19 vaccines that the U.S. Food and Drug Administration (FDA) will make available for use in the United States (by approval or emergency use authorization) are those that meet these standards. To learn more about the approval and emergency use authorizations, please visit our Vaccine Information page.
Continued monitoring of the vaccine is very important. For information on COVID-19 vaccine monitoring in patients with IBD, click here.
Is the number or timing of vaccine doses different for children?
Everything about dosing is the same for all age groups at this time: two shots of the Pfizer-BioNTech vaccine, each scheduled about 21 days apart. Studies of the Pfizer-BioNTech vaccine and other vaccines confirmed that the dosing regimen should work well in this age group and provide immunity with few side effects.
Does the COVID-19 vaccine cause side effects in children?
The vaccine has been tested in about 2,200 adolescent participants ages 12 to 15. The most reported side effects in the adolescent clinical trial were pain at the injection site, tiredness, headache, chills, fever and joint pain. Side effects typically lasted for 1-3 days, and more participants reported these side effects after the second dose than after the first. The side effects in adolescents were consistent with previous trials that included participants ages 16 and older. It is important to recognize that these side effects indicate that the immune system is making a response. The COVID-19 vaccine should not be given to anyone with a known history of severe allergic reaction. You are encouraged to talk to your child’s healthcare provider about what to expect after vaccination, including frequently experienced side effects.
What if my child is on immune-suppressing medications?
There is no data to suggest that immune-suppressing medications (such as immunomodulators, or biologics) impact COVID-19 vaccine response. Research studies are underway to gain a better understanding of the impact of the COVID-19 vaccine on patients with Crohn’s disease and ulcerative colitis, including side effects, effectiveness, and disease activity. It is important to continue taking prescribed medications and talk to your child’s healthcare provider about any concerns or questions related to your treatment and risk for COVD-19.
What if my child is currently on steroids?
If your child is actively taking steroids as part of their IBD management plan, please talk to your child’s healthcare provider about getting vaccinated and the option to reduce the dose of steroids.
When will children younger than 12 be eligible for the vaccine?
At this time, there are preliminary clinical trials underway to study safety and efficacy of the COVID-19 vaccine in children under 12. According to current developments, the vaccine might be available to all age groups as early as this fall. When vaccines do become available for your child, we encourage you to talk to your child's healthcare provider about their current disease state and recommendations for vaccination.
For information on the COVID-19 vaccines, and updates about the impact to IBD patients, please visit our general COVID-19 vaccination guidance.
We will continue to keep the IBD community updated about the safety and efficacy of COVID-19 vaccines for pediatric patients. In the interim, please visit our Pediatric Patient Guidance for up-to-date information on managing infusions, medical appointments, school, and emotional health for kids with IBD. General information on kids and IBD is available in our resources for Parents, Teens, and Kids.
For those interested in Camp Oasis, please check the site for updates about 2021 virtual and residential camp options.
- FDA EUA authorization in children for Pfizer-BioNTech mRNA vaccine
- CDC: FAQ’s on the COVD-19 Vaccine
- General information on Pediatric Clinical Trials
- Health Maintenance Discussion Guide - For Parents & Caregivers
- Pediatric Healthcare Maintenance Checklist – For Professionals
Last updated July 2022