Participation by families of all backgrounds is critical to developing vaccines that protect children against the latest variants of COVID-19, including those who are most at-risk. Every new vaccine breakthrough helps us reach more communities to prevent and reduce the spread of disease.
Introducing an updated COVID-19 vaccine clinical trial for children 5 to 11 years of age who are at increased risk of severe illness.
Some children are more likely to develop severe symptoms and complications from COVID-19. Staying up to date on your child’s COVID-19 vaccines is still the best way to prevent serious illness. However, as the virus continues to change, vaccines must be updated as well.
This study will help us learn if an updated COVID-19 vaccine is safe, and if it can help the immune system defend against new variants of the virus in children 5 to 11 years of age who are at increased risk of severe illness.
Who may participate
Joining a clinical trial is an important decision. Thank you for considering participation as an option that may be right for your child.
This clinical trial may be an option for children who are 5 to 11 years of age and:
- Have at least 1 medical condition that increases their risk of severe COVID-19, such as:
- Lung conditions like asthma or cystic fibrosis
- Chronic kidney or liver disease
- Cancer
- Diabetes
- Disabilities like autism, ADHD, cerebral palsy, or Down syndrome
- Heart conditions (not including myocarditis or pericarditis)
- HIV
- Mental health disorders
- Neurologic conditions (seizures)
- Obesity
- Physical inactivity (10 minutes of exercise per week or less)
- Have not been diagnosed with COVID-19 recently
- Have not received a COVID-19 vaccine recently
- Do not have a history of severe allergic reactions associated with any vaccine
There are other requirements for taking part in this clinical trial. The study team will explain these to you if you’d like to learn more.
Condition
COVID-19
Age
5 to 11 years
Medical and vaccination history
At least 1 risk factor for severe COVID-19 and have not received a COVID-19 vaccine recently
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this study is a good fit for your child and you agree to have them take part, here’s what you can expect:
- Your child will receive 1 dose of the study vaccine as an injection (shot) in the upper arm.
- Participation lasts about 6 months and includes at least 2 in-person visits and 1 phone call with the study team.
- There is no cost to participate. You will also be reimbursed for study-related expenses.
We know nothing is more important to you than your child’s well-being. Before joining the study, you will be given all the details about participation, including potential benefits and risks. Your child’s health will be carefully monitored throughout the study by the study team.
Number of vaccine doses
1 dose
Study visit schedule
At least 2 in-person visits and 1 phone call over about 6 months
Study-related costs
No cost to participate, and health insurance is not needed
About the study vaccine
About the study vaccine
The study vaccine is a modified version of Pfizer-BioNTech’s original mRNA-based COVID-19 vaccine. The updated formulation is designed to improve protection against the latest circulating variant of the COVID-19 virus recommended by the US Food and Drug Administration (FDA) and] World Health Organization (WHO) for 2025-2026 vaccines. It is currently approved for use in individuals 5 to 64 years of age with at least one underlying condition that puts them at risk of severe outcomes from COVID-19.
Participation matters
Participation matters
Frequently asked questions
What are the possible benefits of having my child participate in this clinical trial?
Your child will receive a vaccine that may reduce their risk of severe illness from COVID-19. Additionally, their health will be closely monitored by the study team, and they will be contributing to research that could help protect millions of others around the world.
What are the potential risks of having my child participate in this clinical trial?
As with any vaccine, local reactions at the injection site can be common – such as redness, swelling, or pain. There is also potential for other symptoms like a fever or more serious side effects, including an allergic reaction. Study-related blood draws may cause discomfort, bruising, bleeding, and in rare cases, infection. There may be other risks that are unknown at this time. The study team will provide more information about the potential benefits and risks of taking part.
Will my child receive a placebo?
No, a placebo (injection with no vaccine) is not being used in this clinical trial. All participants will receive 1 dose of the study vaccine.
Are clinical trials safe?
While all clinical trials come with some risks, participant safety is always the top priority. Clinical trials are reviewed and approved by committees responsible for protecting the rights and safety of all participants. These committees continue to regularly review the trial’s progress to ensure there are no unnecessary or excessive risks to participants.
What kinds of tests and procedures will be performed?
At the beginning of the clinical trial, the study doctor will ask about your child’s medical history, including previous vaccinations and any medications they are currently taking. Your child will also have their blood drawn 2 times during the 6 months they are in the clinical trial. The study team will give you more information about the tests and procedures during the review of the informed consent document (ICD).
Is there anything I am required to do outside of going to study visits?
You will need to use an electronic diary (eDiary) to report any changes in your child’s health every day for at least 7 days after their vaccination. You will also complete a COVID-19 illness eDiary once a week, or any time your child is experiencing potential symptoms of COVID-19. The study team will provide more information about the eDiaries during the review of the ICD.
What if I change my mind?
Participation is your choice. You or your child can choose to leave the clinical trial at any time, for any reason.
