Studies

Introducing an updated COVID-19 vaccine clinical trial for children 5 to 11 years of age who are at increased risk of severe illness.

Please take one to learn more.

About this trial

Who can take part

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:

• Chronic kidney or liver disease
• Cancer
• Diabetes
• Disabilities like autism, ADHD, cerebral
• palsy, or Down syndrome
• Heart conditions (not including
• myocarditis or pericarditis)
• HIV
• Lung conditions like asthma or
• cystic fibrosis
• 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 that the study team will discuss with you.

What to expect

If this study is a good fit for your child and you agree to have them take part, here is what you can expect:

Study vaccine

Your child will receive 1 dose of the study vaccine as an injection (shot) in the upper arm.

Study duration

Participation lasts about [6] months and includes at least [2] in-person visits and [1] phone call.

Study-related costs

There is no cost to participate. [You will also be reimbursed for study-related expenses.]

Participation in this clinical trial is completely voluntary. Your child can leave the study at any time, for any reason.

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.

Your child’s safety is the top priority. Before joining the study, you will be given all of the details about participation, including potential benefits and risks. Your child’s health will be carefully monitored through the clinical trial by the study team.

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.

By participating in this clinical trial, your child will receive a COVID-19 vaccine that may reduce their risk of severe illness while contributing to research that could help protect millions of others around the world. So, thank you for taking the time to learn more.

Tomorrow’s breakthroughs start today with you

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.

Ready to learn more?

For more information, contact our study team 786-772-0510