Frequently Asked Questions

The purpose of this study is to determine the efficacy and safety of a single dose of NVX-CoV2705, a COVID-19 vaccine developed by Novavax, among healthy adults aged 50 to 64.

To be included in this study, you must:

• Be 50 to 64 years old when joining the study.
• Not have received a COVID-19 vaccination within the 90 days prior to joining the study.
• Not have had a known COVID-19 infection within the 90 days prior to joining the study.
• Be willing to give informed consent prior to enrolling and to comply with study procedures.
• (If a female of childbearing potential) Agree to be heterosexually inactive from at least 28 days prior to enrollment through 90 days after vaccination OR agree to consistently use a medically acceptable method of contraception during the same timeframe.
• Agree not to participate in any research involving investigational products (drug/biologic/device), including other COVID-19 prevention or treatment trials, for the duration of the study.

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

• Considered to be at high risk of severe COVID-19 due to underlying medical conditions or risk factors.
• Have unstable acute illness at the time of enrollment.
• Existing participation or planned participation during the study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
• Have had a known COVID-19 infection within the 90 days prior to study enrollment date.
• Any known history of allergies to products contained in the investigational product.
• Any known history of anaphylaxis to any prior vaccine.
• Any known history of myocarditis or pericarditis.
• Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study enrollment date.
• Received immunoglobulin or blood-derived products within 90 days prior to study enrollment date.
• You are pregnant, or plan to become pregnant, within 90 days following study enrollment date.
• Any other condition that, in the opinion of the investigator, would pose a health risk to you or could interfere with evaluation of the study vaccine or interpretation of study results.

The University of Utah is conducting this study alongside Novavax Inc. and multiple other sites across the U.S. Novavax Inc. is a vaccine company based in Gaithersburg, Maryland, that is supporting and funding the study. Novavax Inc. will be contributing the COVID-19 vaccine to the study.

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

• Schedule and attend a screening/vaccination appointment at one of our clinic locations.
• Complete an informed consent and HIPAA authorization form, as well as an eligibility screening.
• At appointment, be assigned randomly to receive either a Novavax COVID-19 vaccine (NVX-CoV2705) or placebo (saline injection).
• Complete brief daily electronic health surveys monitoring for COVID-19 symptoms for six months.
• Take an at-home rapid antigen COVID-19 test if you have symptoms for two or more days in a row. If rapid test is positive, have follow-up visit for a physical exam and PCR COVID-19 test
• Complete three phone visits with our study team.
• Receive up to $**** in compensation for your participation.

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 study vaccine is the same one available at the pharmacy this season. The use of NVX-CoV2705 for the participant population in this study is investigational. An investigational use is one that is not approved by the United States Food and Drug Administration (FDA).The study vaccine targets the JN.1 subvariant (a form of a virus that results when a variant [a form of a virus that is slightly different from other forms] of the original form changes) and introduces your body to non-infectious parts (antigens) of the SARS-CoV-2 virus so your immune system can recognize the virus and fight it if you are ever exposed to the virus. These antigens are combined with an adjuvant (Matrix-M™), which helps increase your immune response. Because this study vaccine is not made using an infectious virus, it cannot give you COVID-19.

This is a randomized study. Participants in the study have a 50% chance of receiving the COVID-19 vaccine and a 50% chance of receiving a placebo (saline injection). Participants do not know during the study period whether they received the vaccine or the placebo.

Yes. You do not need to have received a prior COVID-19 vaccination to participate.

No. 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, on the same day.

If you agree to participate, you will be in the study for approximately six months.

Taking part in this study is voluntary. You can leave the study at any time for any reason, and your regular medical care or benefits to which you are entitled will not be impacted.

If you are considering or have already decided to leave the study, you should contact Dr. Sarang Yoon, the study doctor, to discuss the safest way to leave the study. This may involve completing some final tests and examinations. You should also contact your family/personal doctor so they can provide you with the best course of action for your continued care. If you withdraw from the study, you (or legally authorized representative) can ask in writing for your previously retained identifiable samples to be destroyed to prevent further analysis.

If new findings that would affect your safety and willingness to participate in this study are identified while you are in the study, you will be told as soon as possible so you can decide whether to stop or continue the study. If you decide to continue, you will be required to sign a new informed consent form.

Sometimes the study doctor or Novavax may decide it is best for you not to receive the study vaccine or may decide to remove you from the study (even if you do not agree). They will discuss this with you. Possible reasons for doing so include the following:

• It is in your best interest.
• You need a treatment not allowed in this research study.
• The research is canceled by the US FDA or Novavax.
• You cannot receive the study vaccine.
• You are unable to keep your scheduled appointments or follow the study procedures.
• Sponsor can stop the study at any time.

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. The appointment will take place at a University of Utah Health clinic on the campus of the University of Utah. At your appointment, you will be asked to sign an informed consent and HIPAA authorization form. You will be able to review the consent documents prior to your appointment.

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.

Additionally, the following assessments will be performed:

• Background information on you (demographics), medical and surgical history, and previous therapy: You will be asked some questions about your demographics (age, year of birth, sex, ethnicity, and race), health and activity level (including alcohol consumption and drug use), important surgical history, COVID‑19 vaccination history, recent COVID-19 diagnosis, and any medicines or treatments you are currently using or have used in the past.
• Vital signs: Includes checking your heart rate, blood pressure, breathing rate, and body temperature.
• Physical examination: Includes checking your head, ears, eyes, nose, throat, skin, lymph nodes, heart, lungs, abdomen (stomach), muscles and bones, and arms and legs. Your height and weight will also be measured.
• Electrocardiogram (ECG): You will receive an ECG before you receive your vaccination. Electrodes (small patches that stick to the skin) will be placed on your chest, arms, and legs. The electrodes are connected to an ECG machine by wires, and the electrical activity of your heart will be recorded by the machine.
• Urine pregnancy test: If you are able to become pregnant, a urine sample will be collected to make sure you are not pregnant.
• Nose swab to test for COVID-19 (PCR test - a laboratory test used to detect the presence of the SARS-CoV-2 virus's genetic material): A member of the study team at the study site will swab the inside of your nose to determine if you have a current COVID-19 infection. The results of this test will not be made available to the study site or to you.
• Randomization: If you are eligible to participate in this study and have indicated your willingness to participate by signing the informed consent form, you will be randomly assigned to receive either study vaccine or placebo.
• Study Vaccine/placebo administration: A member of the study team will clean the injection site on your arm with an alcohol swab. The study vaccine or placebo will be given as a one-time injection into the muscle of your upper arm. We will ask you to stay at the study site for at least 15 minutes after the injection so that we can see whether you have any immediate reactions to the study vaccine that need medical attention.
• COVID-19 Symptom Diary (eDiary): You will be asked to install a mobile application (“app”) on your smart phone for use during the study. We will help you learn how to use the app called the “COVID-19 Symptom Diary”. You will be given the phone number to a Help Desk, which is available 24 hours a day, 7 days a week in case you need technical assistance with the COVID-19 Symptom Diary app. If you have issues entering information into the app, please contact the study site.
• Temperature monitoring: You will be given an oral (used in your mouth) thermometer and instructed on how to take your temperature.
• Rapid antigen test: You will be given several rapid antigen tests and instructed on how to use the rapid antigen tests at home to see if you have COVID-19.
• Patient Card: You will be given a Patient Card that lists signs and symptoms of COVID‑19 to use with the COVID-19 Symptom Diary app.

Throughout the six months of your participation, you will receive an electronic daily reminder on your smart phone or other device to monitor for symptoms of COVID-19. In addition, you will have three visits conducted by phone call to monitor your health during the study. If you have COVID-19 symptoms for two or more days in a row, you will be asked to check your temperature and take a rapid antigen test (a type of test that quickly detects the presence of SARS-CoV-2 virus antigens) at your home for three days in a row. If you have a positive rapid antigen test result, you will be asked to come to the study site for a visit (this visit is called an Acute Illness Visit). The Acute Illness Visit and rapid antigen testing may need to be repeated more than once if you experience COVID-19 symptoms on separate occasions over the course of the study. You may also be asked to come to the study site for an additional unscheduled visit if you call about a medical concern.

There is no guarantee that you will receive any benefits. However, you might benefit from receiving a vaccine against COVID-19, and you will be helping by contributing to medical research.

Any study has risks, which may include things that could make you sick, make you feel uncomfortable, or harm you. You might experience side effects related to the study vaccine while participating in the study. All participants in the study will be watched carefully for any side effects; however, the study team does not know all the side effects that the study vaccine may have on you.

All vaccines have a possible risk of an allergic reaction. Some signs of an allergic reaction are as follows:

• Rash
• Difficulties in breathing
• Wheezing with breathing
• Sudden change in blood pressure that can cause dizziness or fainting
• Swelling around the mouth, throat, or eyes
• Fast pulse
• Sweating

Most side effects begin soon after the vaccination and last for a few days. However, sometimes side effects can be serious, long lasting, or life-threatening or can result in death. If a severe side effect or reaction occurs, your study doctor will discuss the best way of managing any side effects with you.

Additional possible discomforts and risks that may be associated with the study procedures include:

• ECG: Skin irritation is rare but could occur during an ECG from the electrode patches or gel that is used.
• Blood pressure: The blood pressure cuff used to take your blood pressure may cause discomfort or bruising to your upper arm, although the procedure is similar to that performed during your routine medical care.
• Nose Swab: You may experience discomfort, eye watering, sneezing, or bleeding.

Other side effects have been observed with this SARS-CoV-2 vaccine (COVID-19 vaccine):

• The most common injection site side effects include pain and tenderness, which were mostly mild and generally lasted less than 2 days. Other injection site side effects include redness and swelling.
• The most common general side effects after study vaccination include headache, tiredness and feeling ill, and muscle aches, which were generally mild. Other general side effects include joint pain, nausea and vomiting, and fever. All side effects generally had short durations (less than 2 days).
• Rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) have been reported in a small number of participants in clinical studies. Whether these conditions were caused by the study vaccine is unknown. These side effects have also been reported from people who received mRNA vaccines and were seen more often in male adolescents and young adults after the second dose of the study vaccine. However, they have also been seen in women and older adults and after the first dose. The symptoms resolved with conservative management for most individuals.
• Anaphylaxis, which is a severe potentially life-threatening allergic reaction, is possible with administration of any vaccine; however, no such reactions have been observed in any Novavax clinical studies to date.

The study vaccine includes something called an adjuvant (Matrix-M™), which helps increase your immune response. Side effects experienced to date by participants in clinical studies with the Matrix-M adjuvant include pain and tenderness at the injection site, as well as headache, fatigue, and muscle pain. These are symptoms that can occur with vaccines in general but can be up to two times more common with an adjuvant. So far, no serious health concerns have been identified as being related to receiving the Matrix-M adjuvant.

Autoimmune diseases are believed to be a potential side effect of vaccines with adjuvants. These are serious diseases that can occur in the general population as well (without administration of a vaccine). Autoimmune diseases involve the immune system attacking the body’s own tissues. Autoimmune disease can affect the heart, skin, blood, metabolism, nervous system, thyroid, muscles, joints, liver, and/or kidneys. There is no evidence that this study vaccine or the Matrix‑M adjuvant is associated with an increased risk of autoimmune disease.

The study vaccine may involve unknown risks to a pregnant woman, an embryo, a fetus (unborn baby), or a breastfeeding infant.

If you are pregnant, planning to become pregnant, or breastfeeding a child, you cannot take part in this study. Before entering this study, a pregnancy test will be done for all women able to become pregnant. This test might not detect an early pregnancy. Pregnancy tests must be performed on Day 0 prior to vaccination.

Female participants who are able to become pregnant must use a medically acceptable birth control method from at least 28 days before enrolling in the study and through 90 days after receiving the study vaccine. Medically acceptable birth control methods include condoms/diaphragm/cervical cap with spermicide; intrauterine device (IUD); vaginal ring; birth control in pill, patch, implant, or injection form; or sexual abstinence (defined as no heterosexual intercourse when in line with the participant’s preferred and usual lifestyle) during the study. The study doctor will discuss birth control methods with you.

If you become pregnant during this study, you should tell the study doctor as soon as possible. You will be asked to continue participation in the study, and Novavax will want to receive updates on the progress of the pregnancy, its outcome, your status, and your child’s status at birth.

If you require medical treatment for an illness or injury that is a direct result of the study, Novavax will pay for reasonable and necessary costs of such treatments that are not already covered by your insurance.

Novavax is not responsible for payment or reimbursement for any other injury-related costs such as lost wages, compensation for pain and suffering, or treatment costs of pre-existing conditions.

To pay medical expenses, Novavax will need to know some information about you like your name, date of birth, and Medicare Beneficiary Identifier (MBI). This is because Novavax has to check to see if you receive Medicare and if you do, report the payment it makes to Medicare.

After declaring COVID-19 to be a public health emergency, the US Department of Health and Human Services issued a public health declaration, called the Public Readiness and Emergency Preparedness Declaration (PREP) on March 10, 2020, covering countermeasures against COVID-19. This declaration limits the legal rights of a participant participating in a COVID-19 clinical study that uses a drug, device, or vaccine designed to treat, diagnose, cure, or prevent COVID-19. This includes the study vaccine used in this study. Participants receiving vaccination in this study will have limits on their right to sue the manufacturers, the study sponsor, healthcare providers, and others for significant injuries and adverse reactions.

The ending of the public health emergency on May 11, 2023 does not automatically terminate PREP coverage or protections related to COVID-19. Whether PREP continues to limit the legal rights of participants in a COVID-19 clinical study after the public health emergency has ended depends on a number of complex and evolving factors. If PREP liability protections apply to this study, participants who use NVX-CoV2705 in this study, may have limits on their right to bring legal claims against the manufacturers, the study sponsor, or healthcare providers involved in the study.

By consenting to participate in the study, you acknowledge and understand that certain legal rights to sue related to your participation in this study will be limited under PREP; however, you do not give up any other your legal rights, and you are not releasing the researchers, the sponsor, or any healthcare providers from their responsibilities under applicable state laws.

There is no cost to you to take part in the study. The study vaccine will be given at no cost to you, and you will not be charged for any study doctor visits, laboratory work, tests, or procedures needed for the study.

You will be paid up to a total of $xx.xx if you complete the entire study. You will receive payment for each study visit that you complete, even if you do not finish the study. Payments will be made [“following each completed visit”, “monthly”, “quarterly”, “at the end of your participation in the research study”, “following each completed visit or at the end of your participation in the research study, whichever you prefer”]. The payment schedule is as follows:

• $xx.xx for Visits xxx.
• $xx.xx for Visits xxx.
• $xx.xx for Visits xxx.

You will be paid $XX for each telephone call visit that occurs on Day 42, Day 90, and at the end of the study. In addition, you will be compensated up to $XX.00 per day for each day that you answer the diary prompt.

If you have any questions regarding your compensation for participation, please contact the study staff.

Records of your participation in this study will be confidential except when sharing the information is required by law or as described in this informed consent. The study doctor, Novavax or persons working on behalf of Novavax and, under certain circumstances, the US FDA and the Institutional Review Board (IRB) will be able to inspect and copy confidential study-related records which identify you by name. This means that absolute confidentiality cannot be guaranteed. If the results of this study are published or presented at meetings, you will not be identified.

As part of this research, you may be required to use one or more of the following: a phone or web app/site or a device that tracks information about you. While using these, information about you may be collected and shared with the researchers or people outside of the study. This data might include personal health information, location, call logs, text message history, web browsing history, or social media use. A complete description of the data collection and sharing for an app or device can commonly be found in the Terms of Use, End User License Agreement, or Privacy Policy associated with the device. If you would like to read these documents, request a copy or instructions about how to access this information from the study doctor.

While the Terms of Use, End User License Agreement, or Privacy Policy may include statements limiting your rights if you are harmed as a result of your use of a device in this study, you do not release the study doctor, Novavax, study site, or agents for responsibilities from mistakes. You also do not waive any of your rights as a research participant.

Personal information may be transferred to another country/locality that may not have the same level of personal information protection as found within your country/locality.

A description of what will happen to your data and other personal information is included in the HIPAA Authorization form that you must sign before participating in the study. Your identity will not be disclosed unless required by law.

If you are a female able to become pregnant, a urine pregnancy testing will be performed at the study site per study plan. The urine samples will be destroyed after the pregnancy test is completed. Nasal swabs collected at the site to monitor for the occurrence of COVID-19 will be destroyed.

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 doctor, at This email address is being protected from spambots. You need JavaScript enabled to view it..