Frequently Asked Questions

The purpose of this research study is:

• To find out if there is a difference in the side effects between the two different types of COVID-19 vaccines.

You may qualify to be in this study if:

• You are at least 18 years of age.
• You are employed as a full-time or part-time healthcare worker or first responder who has direct face-to-face contact (defined as being within 3 feet, or about an arm’s length) with patients for at least 20 hours a week.
• You intend to receive a dose of the updated 2024-2025 COVID-19 vaccine.
• You have received at least one dose of a COVID-19 vaccine in the past four years.
• You are comfortable reading and responding to text messages and emails sent in English or have an interpreter to assist you.
• You have access to the internet (via cell phone, laptop, desktop, etc) to complete online surveys.
• You are able and willing to complete the study activities.

Some reasons you may not qualify to take part in this study are:

• You are taking part in another vaccine or investigational product trial within 90 days of study enrollment.
• You have a history of self-reported severe allergic reaction to prior COVID-19 vaccine.
• You received a COVID-19 vaccine within the past 60 days.
• You plan to receive additional vaccines within seven days after the vaccination appointment for study enrollment. (Vaccines given at the same time or day of COVID-19 vaccination are permissible).

• The University of Utah is conducting this study along with Novavax Inc. and RTI Health Solutions.
• Novavax Inc. is a vaccine company based in Gaithersburg, Maryland, that is supporting and funding the study. Novavax will also be contributing the Novavax 2024-2025 updated COVID-19 vaccine to the study.
• RTI International is a research company based in Research Triangle Park, North Carolina, that is working with the University of Utah to carry out the study.

If you decide to join this study, you will be asked to complete the following activities:

• Attend a study appointment where you will receive your choice of the Novavax 2024-2025 updated COVID-19 vaccine or the updated 2024-2025 Pfizer COVID-19 vaccine.
• On the second and seventh day afterwards, you will be asked to complete an online post-vaccination survey about any reactions you may have experienced.
• We will also ask questions about yourself, your work and health, and COVID-19 and flu vaccinations you may have received.
• You could receive up to $120 in VISA gift cards to thank you for your time and efforts. Exactly how much depends on the number of study activities you complete.

• Coronavirus disease 2019 (COVID-19) is the name of the illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
• Common COVID-19 symptoms include: fever, chills, malaise, fatigue, headache, cough, shortness of breath, sore throat, runny nose or nasal congestion, nausea or vomiting, diarrhea, muscle or body aches, or change in smell or taste. COVID-19 symptoms may range from mild to very severe, and some people may have no symptoms at all.
• Older adults and people of any age who have underlying medical conditions are at higher risk for severe illness from COVID-19.
• COVID-19 vaccines are an important way to prevent COVID-19.

A COVID-19 vaccine causes your body’s immune system to create antibodies against the COVID-19 virus. These antibodies can help protect against a future infection. COVID-19 vaccines cannot give you COVID-19 disease.

• The two types of COVID-19 vaccines used in this study are the updated 2024-2025 Novavax and Pfizer COVID-19 vaccines.
• The vaccines used in this study have received Emergency Use Authorization or Approval by the Food and Drug Administration for safe use in adults.
• None of the study vaccines contain live virus.

In the table below, you can see which vaccines are available and choose which COVID-19 vaccine is best for you.

Source: https://www.cdc.gov/covid/vaccines/how-they-work.html

ACIP recommendation
On June 27, 2024, the CDC Director adopted the ACIP’s recommendations for use of 2024–2025 COVID-19 vaccines in people ages 6 months and older as approved or authorized by FDA.

• Yes. However, you can choose which type of COVID-19 vaccine you receive. In the table below, you can see which vaccines are available and choose which COVID-19 vaccine is best for you.

Source: https://www.cdc.gov/covid/vaccines/how-they-work.html

ACIP recommendation
On June 27, 2024, the CDC Director adopted the ACIP’s recommendations for use of 2024–2025 COVID-19 vaccines in people ages 6 months and older as approved or authorized by FDA.

You will receive proof that you got a COVID-19 vaccine.

Those who have not been previously vaccinated against COVID-19 are not eligible to participate.

There is no recommended waiting period between getting a COVID-19 vaccine and other vaccines. You can get a COVID-19 vaccine and other vaccines, including a flu vaccine, at the same visit.

If you agree to participate, you will be in the study from when you enroll until submitting the online survey on the seventh day post vaccination.

• Taking part in this research study is your choice. This means you can choose to be in the study or not.
• This document may contain words and information that you do not understand. Before deciding whether to take part in this research study, please ask the study staff to explain anything that is not clear to you. Please take time to read the following information carefully and discuss it with friends and relatives or your healthcare professional if you wish.
• You can also choose to stop participating at any time for any reason. Choosing to stop your participation will not result in any penalties and will not affect any care or services you may receive in the future.
• You may change your mind and revoke (take back) your consent and HIPAA authorization by writing to Dr. Sarang Yoon, the study principal investigator, at This email address is being protected from spambots. You need JavaScript enabled to view it. or by calling the study phone number, 801-203-0320. If you revoke your consent and authorization, you will not be allowed to continue taking part in this study and no additional information about you will be collected. However, the study staff may still use information already collected from you for this study.
• The study staff have the right to stop your participation at any time. Examples of why this could happen include because you failed to follow study instructions or because the study has stopped.

• If you agree to participate in the study, you will need to schedule an appointment to meet with our study staff by using the link on our study site. You will be able to review the consent documents prior to your appointment.
• At your appointment, you will sign an informed consent and HIPAA authorization form. The consent form describes the study and asks for permission to check your vaccine records to confirm what kind and how many COVID-19 and flu vaccine(s) you received in the past. These details may come from state and/or city vaccine registries or from past records if you took part in other COVID-19 or flu vaccine studies. You can choose not to give permission to confirm your COVID-19 and flu vaccine history and still be in the study.
• The study appointment is required. The appointment will take place at a University of Utah Health clinic. Various clinic locations and times will be available at or near the University of Utah. Our main research clinic is located at 250 East 200 South, Suite 100, Salt Lake City, UT 84111.

• You will review and sign an informed consent and HIPAA authorization form. You will be given the opportunity to ask questions with the study research team.
• The study staff will ask you which type of vaccine you would like to receive.
• Study staff will ask you some questions to make sure you are feeling well enough to receive the vaccine. If you are not feeling well, you will need to reschedule the appointment.
• A study health care professional will inject one dose of the COVID-19 vaccine (of your choice) in your upper arm. You will be monitored for 15 minutes after vaccination to ensure you do not experience a serious vaccine reaction.
• Study staff will show you how to complete online study surveys.
• Study staff will give you proof that you received a COVID-19 vaccine.

• Taking part in this research study is your choice. This means you can choose to be in the study or not. Receiving a COVID-19 vaccine is required to participant in this study.

• On the second day after getting the vaccine, you will receive a link to an online post-vaccination survey. This survey will take about 20 minutes and will ask about socio-demographic information, any reactions, and impact on your daily activities and work.
• On the seventh day after getting the vaccine, you will receive another link to an online post-vaccination survey. This survey will take about 20 minutes and will ask about socio-demographic information, any reactions, and impact on your daily activities and work.

• The COVID-19 vaccine you receive as part of this study may protect you against COVID-19 by preventing or lessening the effects of severe infection from the SARS-CoV-2 virus.
• Your participation in this study will provide helpful information about the side effects of the COVID-19 vaccines.
• Your participation also has a chance to provide more information about COVID-19 and the SARS-CoV-2 virus. This could benefit you or other people in the future.

What are the risks of receiving a vaccine?

• You may experience mild discomfort where the vaccine was injected into your arm muscle and possible reactions such as redness, swelling at the injection site, swelling of the lymph nodes, pain, or tenderness. Study staff will use sterile equipment and clean the injection site with alcohol to lower the chance of infection.
• Some people who receive a COVID-19 vaccine may experience reactions such as fever, body aches, headache, malaise, myalgia, and/or nausea. These symptoms usually go away on their own in about 1-2 days.
• Like any other COVID-19 vaccine, there is a risk of severe reactions including: shortness of breath, wheezing, hives, hoarseness, difficulty swallowing, swollen face/tongue/pharynx (muscles inside the neck), tachycardia (faster than normal heartbeat), paresthesia (tingling or crawling feeling), hypoesthesia (decreased feeling or sensitivity), dizziness, and/or weakness.
• Myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside of the heart) have occurred in some people who have received the Novavax or mRNA COVID-19 vaccines. Symptoms of myocarditis and pericarditis include chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart, with symptoms most commonly reported as beginning within 10 days after vaccination. These side effects were seen more often in male adolescents and young adults after the second dose of the vaccine. However, they were also seen in women and older adults after the first dose. The chance of having this occur is very low. In the rare case you experience myocarditis or pericarditis symptoms, you should seek immediate medical attention and notify the study staff.

Are there any other risks?

• By taking part in this study, there is a risk that your personal information could be revealed. The study team will handle your personal information in a confidential manner to make this risk as low as possible. Study staff will follow strict guidelines to keep your information secure and will take steps to protect your privacy, such as:
  • A study number instead of your name will be used on study records wherever possible.
  • Study staff will protect information that is stored electronically by using secure passwords and will protect information stored on paper using a locked file cabinet in a locked office that only study staff can access.
  • Study results and reports that are presented or published will not use your name or any other personal information that could identify you.

• If you are injured from being in this study, medical care is available to you at the University of Utah, as it is to all sick or injured people.
• The University of Utah has not set aside any money to pay the costs for such care. The University will work with you to address costs from injuries. Costs would be charged to you or your insurance company (if you have insurance), to the study sponsor or other third party (if applicable), to the extent those parties are responsible for paying for medical care that you receive.
• Since this is a research study, some health insurance plans may not pay for the costs. By signing this consent form you are not giving up your right to pursue legal action against any parties involved with this research.
• The University of Utah is a part of the government. If you are injured in this study, and want to sue the University or the doctors, nurses, students, or other people who work for the University, special laws may apply. The Governmental Immunity Act of Utah is a law that controls when a person needs to bring a claim against the government and limits the amount of money a person may recover. See sections 63G -7-101 to -904 of the Utah Code.

• You do not have to be in this study to get a COVID-19 vaccine.
• For information about where you can get the COVID-19 vaccine outside of the study, you can contact your local health provider, clinic or pharmacy.

• There is no cost to you to take part in this study.
• The study will provide the COVID-19 vaccine that will be given to you.
• Standard message and data rates will apply for receiving and sending study text messages.

• To thank you for your time and efforts, we will send you up to $120 in electronic gift cards.

• The Health Insurance Portability and Accountability Act (HIPAA) of 1996, is a federal law that put safeguards in place to protect the privacy of patient’s health information, known as protected health information (PHI), from being shared without the patient’s consent or knowledge.
• HIPAA gives patients control over who their information is shared with and for what purpose.

• If you give your consent to take part in this study, you are giving your authorization (permission) for study staff to use your PHI and information collected during the study that may identify you, such as your name, address, phone number, and email address.
• Study staff will not ask for your social security number or other government ID number.
• The health information collected and used for this study includes information about past or current medical conditions, medications or treatments, and family medical history.
• The authorization to use and share your health information does not have an expiration (ending) date.
• The permission that you give allows study staff to look at your PHI and information collected that may identify you and share it with the University of Utah and RTI International for analysis.
• The research records may be also be used and reviewed by the University of Utah Institutional Review Board (IRB), which reviews research involving people to make sure the study protects your rights; the University of Utah Clinical Research Support Office Monitoring and Quality Assurance group, which helps oversee how the study is carried out; the FDA; and Novavax, the study sponsor. Novavax will not receive any information from this study that could identify you. In other words, they will only receive de-identified information. Novavax may keep the de-identified information from this study indefinitely.
• Study staff may also share your PHI with review boards and other persons who watch over the safety, effectiveness, and conduct of research, such as authorized persons from the Office of Human Research Protections (OHRP). However, study staff will not share with these review boards or persons any information that could identify you, such as your name or contact information.
• If you do not want your health information used, you should not be part of this research. If you choose not to participate, you can still receive health care services at University of Utah Health Sciences Center.

• You will also be asked for permission to check vaccine records to confirm what kind and how much of the COVID-19 and flu vaccine you received in the past. This history may come from state and/or city vaccine registries or from past records if you took part in other COVID-19 or flu vaccine studies.
• You can choose not to give permission to confirm your COVID-19 and flu vaccine history and still take part in this study.

• You can stop participating in the study at any time for any reason.
• You can tell us any time that you do not want to be in this study and do not want us to use your health information.
• You may change your mind and revoke (take back) your consent and HIPAA authorization by writing to Dr. Sarang Yoon, the study principal investigator, at This email address is being protected from spambots. You need JavaScript enabled to view it. or by calling the study phone number, 801-203-0320.
• If you revoke your consent and authorization, you will not be allowed to continue taking part in this study and no additional information about you will be collected. However, the information you provided while on the study may continue to be used in the final study reports.
• The study staff also have the right to stop your participation at any time. Examples of why this could happen include because you failed to follow study instructions or because the study has stopped.

• For general questions or concerns about the study, call or text 801-203-0320 or send an email to This email address is being protected from spambots. You need JavaScript enabled to view it..
• You may also contact Dr. Sarang Yoon, the study principal investigator, at This email address is being protected from spambots. You need JavaScript enabled to view it..

• For questions about your rights and welfare as a research participant or for a research-related injury, please contact the University of Utah Institutional Review Board (IRB) or by email at This email address is being protected from spambots. You need JavaScript enabled to view it.. at (801) 581-3655. You can also contact the IRB if you have questions, complaints, or concerns that you do not feel comfortable discussing with study staff.
• Another resource for people who volunteer to participate in research studies at the University of Utah is the Office for Research Participant Advocacy (ORPA). You can contact your Research Participant Advocate by phone at (801) 581-3803 or by email at This email address is being protected from spambots. You need JavaScript enabled to view it..

• If you are experiencing a mental health crisis, please call or text 988 to reach a licensed mental health professional at the Suicide and Crisis Lifeline.
• Crisis Support websites can be found here:
  • https://healthcare.utah.edu/hmhi/programs/crisis-diversion
  • https://safeut.org/
• For non-crisis mental health concerns and links to support groups go to: https://www.namiut.org/