Introducing a clinical trial for adults and adolescents 12+, including those who are at increased risk of severe illness from COVID-19.
Who can take part?
This study is enrolling participants who:
Are at least 65 years of age, OR are 12-64 years of age and have at least 1 of the following medical conditions:
•Asthma
•Diabetes I or II
•Heart conditions such as previous coronary artery disease, heart failure, or cardiomyopathy
•Cancer
•Cerebrovascular disease (stroke)
•Chronic kidney, lung, or liver disease
•Cystic fibrosis
•Disabilities such as cerebral palsy, autism, ADHD, Down syndrome, other chromosomal disorders, etc.
•Physical inactivity (10 minutes per week or less)
•Tuberculosis
•Weakened immune system
•HIV
•Depression or schizophrenia spectrum disorders
•Parkinson’s disease or dementia
•Obesity (BMI ≥30 or ≥95th percentile in children)
•Current or former smoker
Have never received a COVID-19 vaccine or received a COVID-19 vaccine more than 5 months ago, and have not been diagnosed with COVID-19 within the last 5 months.
Do not have a history of a severe reaction associated with any vaccine or vaccine component.
There will be other requirements that the study team will discuss with you.
What to expect
All participants will receive 1 dose of the study vaccine as an injection in the upper arm.
Study duration
Participation lasts for about 6 months.
Study visits
Participants will have at least 3 visits with the study team.
Study-related costs
There is no cost to participate in this study, and health insurance is not required. Participants will also be paid for completing study-related activities.
About the study vaccine
The study vaccine is a modified version of Pfizer and BioNTech’s original mRNA-based COVID-19 vaccine, which has been authorized for use in more than 149 countries. The modified formulation is designed to improve protection against Omicron LP.8.1, the COVID-19 variant recommended by the Food and Drug Administration (FDA) for the 2025-2026 respiratory virus season.
Safety is our top priority
Before you or your child chooses to participate, you will be given all the details about the clinical trial, including potential benefits and risks. Participants’ health will be closely monitored throughout the study.
Pursuing updated protection against COVID-19
Staying up to date on your COVID-19 vaccines is still the best way to prevent severe illness, especially for those with certain risk factors. However, as the virus continues to change, vaccines must evolve as well. That’s why we’re developing an updated COVID-19 vaccine for the 2025-2026 respiratory virus season.
About this clinical trial
This clinical trial will help us learn if an investigational formulation of our COVID-19 vaccine is safe, and if it can help the body produce antibodies to fight off new variants of the COVID-19 virus.
Your participation in this clinical trial will contribute to the development of an updated COVID-19 vaccine that may increase protection for millions of people around the world. So,
thank you for taking the time to learn more.
Tomorrow’s breakthroughs start today with you
Participation by people of all backgrounds is critical to developing vaccines that protect against COVID-19. The greater the representation among clinical trial participants, the more we can learn about potential vaccines and how they work for different people. Your participation could make a difference.
Ready to learn more?
For more information, reach out to our study team.
786-772-0510
