Participation by people of all backgrounds is critical to developing vaccines that protect against infectious diseases like COVID-19 and flu. The greater the diversity among clinical trial participants, the more we can learn about potential vaccines and how they work for different people, including those most at-risk because of their age, race, ethnicity, or where and how they live. Each new vaccine breakthrough helps us reach more people to prevent and reduce the spread of disease.
Learn more about Pfizer and BioNTech’s clinical trial for a COVID-19 and flu combination vaccine using mRNA technology.
Both COVID-19 and flu continue to be major public health concerns around the world. Because infections tend to peak in the winter months, vaccination programs for COVID-19 and flu are likely to occur at the same time each year. A combination vaccine will make it easier and more convenient to get protection against both infections with just one shot.
This clinical trial will help us understand how people respond to different dose levels of a combination vaccine compared to receiving different dose levels of the flu vaccine or COVID-19 vaccine when given alone.
Who may participate
Joining a clinical trial is an important and personal decision. We thank you for considering participation.
This study is enrolling healthy adults who:
- Are at least 65 years old
- Have not received a flu or COVID-19 vaccine for the 2024-2025 season (given after approximately August 2024)
- Have not tested positive for flu in the last 6 months
- Do not have a history of severe allergic reactions associated with any vaccine
There are other requirements for taking part in this study. The study team will explain these to you if you’d like to learn more. To see if you may qualify to participate, click “Get Started.”
Age
65+ years
Medical and vaccination history
Generally health and have not received a COVID-19 or flu vaccine for 2024-2025 season
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.
Get started — See if you may be eligible
Answer a 5-minute questionnaire.
A first step as you consider this study is to answer a 5-minute online questionnaire about your health and medical history. If your answers show the study might be a good fit for you, you may choose to be referred to a study clinic that you select.
Speak with a study representative.
If you’re interested, you will then be asked to provide your contact information for a study representative to contact you and discuss the next steps.
Confirm your eligibility.
Your answers to these questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.
What to expect
If this clinical trial is a good fit for you and you agree to participate, you will be randomly assigned (like rolling dice) to one of the following groups:
- Group 1: Investigational mRNA flu vaccine plus placebo
- Group 2: Licensed or investigational mRNA COVID-19 vaccine plus placebo
- Group 3: Investigational flu and COVID-19 combination vaccine plus placebo
- Group 4: Licensed flu vaccine plus licensed COVID-19 vaccine
All participants will receive vaccines for COVID-19 and/or flu at their first study visit. Some participants will also receive a placebo injection. The placebo looks like the study vaccines, but it does not contain any active ingredients. The study team will explain more about the vaccine groups.
Length of study
6 months
Number of study visits
At least 3 visits
About the study vaccines
About the study vaccines
The vaccines being studied are a combination of Pfizer and BioNTech’s updated COVID-19 vaccine and an investigational mRNA-based flu vaccine being developed by Pfizer.
mRNA vaccines do not contain any killed or weakened virus. Instead, they work by telling your body to produce proteins that look just like certain parts of the virus. The immune system reacts to these proteins in a similar way to a real virus. As a result, certain immune system cells “remember” how to recognize these proteins quickly and fight the real infection if it happens in the future.
Your participation matters
Your participation matters
Frequently asked questions
Will I know which vaccine(s) I am receiving?
No, neither you nor the study doctor will know which vaccine(s) you have received. The person giving the injections will know but will not be able to talk about it with you.
Is there a cost to participate?
The study vaccines and study-related procedures will be provided at no cost. You will also be reimbursed for each study visit completed.
What if I change my mind?
Participating in a clinical trial is completely voluntary (your choice). You can choose to leave the study at any time, for any reason, without penalty to you. If you decide not to participate, your future medical care will not be affected.
Can I receive other COVID-19 and/or flu seasonal vaccines while participating in this clinical trial?
If you take part in this clinical trial, it is important that you do not receive other seasonal flu and/or COVID-19 vaccines until you have completed the one-month follow-up visit. After your follow-up visit, you may be told which vaccine you received so you can get a licensed flu or COVID-19 vaccine. Participants interested in obtaining other seasonal flu or COVID-19 vaccines during the study should discuss this with the study doctor.
What are the possible side effects?
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 mild fever or fatigue. The known side effects will be further explained in the informed consent document and discussed with you by the study doctor before you join the clinical trial. If we learn any new information about the study vaccine during the clinical trial, the study doctor will share that with you as well.
What kinds of tests and procedures will be performed?
At the beginning of the clinical trial, the study doctor will ask you about your medical history including previous vaccinations and any medications you are currently taking. You will be given an electronic diary to complete for one week after your vaccines so the study team can monitor your health. You will also have your blood drawn three times during the six months you are in the trial. The study team will give you more information about the tests and procedures during the review of the informed consent document.
