An important contribution
Staying up to date on your COVID-19 vaccines is still the best way to protect yourself and others from serious illness. However, as the virus continues to change, vaccines must
evolve as well. For this reason, we are looking for ways to make our current COVID-19 vaccine more effective against the newest variants.
Your participation in this clinical trial will contribute to the development of the next generation of COVID-19 vaccines that may increase protection for millions of people around the world. So, thank you for taking the time to learn more.
Participation matters
Factors such as genetics, race, ethnicity, gender, and age can affect a person’s risk for severe infectious diseases and how they respond to a vaccine. In the U.S., African Americans, Alaskan Natives, American Indians, Latino people, and adults over the age of 50 are more significantly impacted by severe illness and hospitalizations from COVID-19 than other groups. 1,2,3
That is why it is so important that clinical trials include people of all backgrounds. Everyone needs to be represented. With your help, we can advance research that may improve protection against COVID-19 for everyone.
About this study
This study will help us learn if an investigational formulation of our COVID-19 vaccine is safe and can help the body produce antibodies to fight off new variants of COVID-19. The study vaccine is a modified version of Pfizer-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 COVID-19 by targeting new variants [including [XBB]] more effectively.
Who can participate?
This study is enrolling people who:
- Are [at least 12 years old]
- Are generally healthy or have stable chronic conditions and no history of myocarditis or pericarditis
- Received at least three prior doses of an mRNA COVID-19 vaccine (Pfizer-BioNTech or Moderna), and the last dose was a bivalent vaccine* given at least five months ago
*In the U.S., all COVID-19 vaccine doses administered after September 1, 2022 are considered bivalent.
What to expect
- All participants will receive a single injection of the study vaccine. This study does not include a placebo (injection with no active ingredient).
- Participants will be enrolled in the study for about six months and will need to attend at least five study visits during this time.
- Participants may be reimbursed for expenses and time related to completing study activities.
Your safety is the top priority
Safety is always the top priority of any research study. Before you join the study, you will be given all of the details about participation, including potential benefits and risks. Your health will be carefully monitored throughout the study by the study team.
Volunteering is your choice
Choosing to volunteer for a clinical trial is very personal and many factors may weigh in your decision making. To decide if this research study is a good fit, it’s important to understand the process and what is required. If you would like to participate, you will provide your consent (permission) before joining the study. You are also free to stop being in the study at any time, for any reason.
References
1. CDC.gov. Factors That Affect Your Risk of Getting Very Sick from COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/your-health/risks-getting-very-sick.html. Accessed May 4, 2023.
2. CDC.gov. People with Certain Medical Conditions. https://www.cdc.gov/coronavirus/2019-ncov/need-extraprecautions/people-with-medical-conditions.html. Accessed May 4, 2023.
3. CDC.gov. Health Equity: Promoting Fair Access to Health. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/index.html. Accessed May 10, 2023.
