As viruses continue to change, vaccines must be updated. Learn more about our updated COVID-19 vaccine clinical trial for healthy adults 50 to 64 years of age.

Staying up to date on your 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 clinical trial will help us learn if a COVID-19 vaccine is safe, and if it can help the immune system defend against new variants of the virus in healthy adults who are 50 to 64 years old and do not have risk factors for severe COVID-19.

Who may participate

 

This clinical trial may be an option if you: 

  • Are 50 to 64 years old
  • Are healthy with no major changes in your recent medical history
  • Have not tested positive for COVID-19 within the last 3 months
  • Have not received a COVID-19 vaccine within the last 3 months
  • Do not have a medical condition that increases your risk of severe COVID-19, such as: diabetes, cancer, obesity, chronic kidney disease, COPD, depression
  • 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.  

Age

50 to 64 years

Medical and vaccination history

Have not received a COVID-19 vaccine or tested positive for COVID-19 within the last 3 months

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 take part, you will be assigned by chance (like flipping a coin) to receive 1 injection (shot) of either the study vaccine or placebo (injection with no vaccine). Neither you nor the study doctor will know what you have received. 

Participation lasts at least 6 months and includes at least 4 study visits (some visits may be conducted by telephone). You may have an additional visit if you develop symptoms or test positive for COVID-19. 

The study vaccine and study-related procedures will be provided at no cost. You may be paid for completing on-site study visits.

Length of study

At least 6 months

Number of study visits

At least 4 visits

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). 

mRNA vaccines 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.

About the study vaccine

Group of friends talking outside; Group of friends together; Couple together; portrait of woman; portrait of man; family together – Pfizer Clinical Trials
Group of friends talking outside; Group of friends together; Couple together; portrait of woman; portrait of man; family together – Pfizer Clinical Trials

Your participation matters

Portrait of a woman inside; Group of friends talking outside; Group of friends together; Couple together; portrait of woman; portrait of man; family together – Pfizer Clinical Trials
Portrait of a woman inside; Group of friends talking outside; Group of friends together; Couple together; portrait of woman; portrait of man; family together – Pfizer Clinical Trials

Your participation matters

Participation by people of all backgrounds is critical to developing vaccines that protect against the latest variants of COVID-19. Every new vaccine breakthrough helps us reach more people to prevent and reduce the spread of disease.

Frequently asked questions

What are the possible benefits of participating in this clinical trial?

You may receive a vaccine that could reduce your risk of severe illness from COVID-19, and it is possible that you may benefit from seeing the study doctor. Additionally, you will be contributing to research that could help protect millions of others around the world.

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What are the potential risks of participating in this clinical trial?

The study vaccine may cause serious symptoms or 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.

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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.

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What kinds of tests and procedures will be performed?  

At the beginning of the clinical trial, the study doctor will ask about your medical history, including previous vaccinations and any medications you are currently taking. They will also swab your nose to test for COVID-19. You will have your blood drawn up to 5 times during the 6 months you 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). 

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Is there anything I am required to do outside of going to study visits?  

You will use an electronic diary (eDiary) twice a week, or any time you are experiencing potential symptoms of COVID-19. You will be given a nasal swab kit in case you develop potential symptoms of COVID-19 and are instructed by the study team to collect a nasal swab sample at home. 

You may also be asked to report any changes in your health for at least 7 days after receiving your injection. If this applies to you, you will receive a thermometer to measure your temperature and a device to measure any redness or swelling that happens at the injection site. The study team will provide more information about the eDiaries during the review of the ICD.  

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What if I change my mind?

Participation is your choice. You can choose to leave the clinical trial at any time, for any reason.

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Can I receive another COVID-19 vaccine while participating in this clinical trial?

No, you should not receive any other investigational or licensed COVID-19 vaccine while you are in this clinical trial.

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