COVID-19 (12y+) vaccine, Nuvaxovid (2026-2027)

COVID-19 is a serious illness caused by a coronavirus known as SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 spreads from one person to another through the air.

COVID-19 can impact your lungs or other organs. Symptoms can range from mild to severe and may include fever, chills, cough, sore throat, shortness of breath, tiredness, body aches, headache, loss of taste or smell, runny or stuffy nose, nausea, vomiting, or diarrhea.

Nuvaxovid vaccine is used to prevent COVID-19 in individuals who have never been vaccinated before or who have already received a COVID-19 vaccine.

Nuvaxovid vaccine is used to prevent COVID-19 in people:

• age 65 and older; or
• 12 years through 64 years of age who are at high risk for severe COVID-19.

COVID-19 vaccine does not contain coronavirus and cannot give you COVID-19. This vaccine will not treat an active COVID-19 infection.

Like any vaccine, COVID-19 vaccine may not provide protection in every person.

Read all vaccine information sheets provided to you.

Nuvaxovid COVID-19 vaccine is given as an injection into a muscle.

Nuvaxovid COVID-19 vaccine for people who are at least 12 years old is given:

• to unvaccinated individuals: a single dose of Nuvaxovid COVID-19 vaccine;
• to people who have already received a dose of any COVID-19 vaccine: a single dose of Nuvaxovid COVID-19 vaccine is given at least 2 months after the last dose of any COVID-19 vaccine.

The doctor or vaccination provider will decide if an immunocompromised person needs additional doses.

Continue to use infection control methods when you are in public or around others who may not have been vaccinated. This includes social distancing, hand-washing, wearing protective face coverings, disinfecting surfaces you touch often, and not sharing personal items with others.

Getting a COVID-19 vaccine will not make you test positive on a coronavirus test. However, once your body develops immunity to COVID-19, you might test positive on an antibody test (a test to check for immunity in the body from previous exposure to coronavirus).

It is not known how long this vaccine will protect you from getting COVID-19. It is also not known how long immunity will last for someone who has been infected with and recovered from COVID-19. The COVID-19 vaccine is still being studied, and all of its risks are not yet known. Updated federal public health recommendations can be found at https://www.cdc.gov/covid/index.html.

Getting infected with COVID-19 may pose a much greater risk to your health than getting this vaccine.

You should not receive this vaccine if you had a severe allergic reaction after a previous dose of NUVAXOVID or NOVAVAX COVID-19 vaccine, or if you have ever had a severe allergic reaction to any ingredient of this vaccine.

If you are infected with COVID-19, waiting for test results, or have been exposed to someone with COVID-19: you may not be able to receive this vaccine until you no longer have symptoms and/or your required quarantine period is over. Receiving this vaccine will not reduce how contagious you are to others if you are infected with COVID-19 but do not have symptoms.

Ask your doctor if you are unsure about any COVID-19 treatments you have received.

Tell your vaccination provider if you:

• have any allergies;
• have had inflammation in or around your heart (myocarditis or pericarditis);
• have a fever;
• have bleeding problems or are using a blood thinner;
• have a weak immune system due to a disease or certain medicines (this vaccine may not work as well if you are immunosuppressed);
• are pregnant, planning to become pregnant, or are breastfeeding;
• have received any other COVID-19 vaccine or if you are scheduled to receive a vaccine; or
• have fainted after getting an injection.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

The vaccination provider may want to monitor you for a short time after the injection to ensure you do not have an allergic reaction or faint. You will be treated quickly if there is a reaction right after receiving the vaccine.

Not all possible side effects are known. Getting infected with COVID-19 may be much more dangerous to your health than receiving this vaccine.

Some people experienced inflammation of the heart muscle or the lining around the heart after getting this vaccine, but the chance of this happening is very low. Seek medical help immediately if you have any of the following symptoms:

• chest pain;
• shortness of breath;
• fast or pounding heartbeats, fluttering in your chest;
• fainting; or
• unusual sensations in the skin such as tingling, a crawling feeling, or decreased feeling or sensitivity.

Common side effects of COVID-19 (12y+) vaccine, Nuvaxovid may include:

• fever, chills, swollen glands;
• pain, swelling, redness, tenderness, or itching where the injection was given;
• nausea, vomiting;
• feeling tired, feeling unwell; or
• headache, muscle pain, joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

You may also use a smartphone-based program called V-safe to communicate with the Centers for Disease Control and Prevention (CDC) about any health problems you have after receiving a COVID-19 vaccine: www.cdc.gov/vsafe

Usual Adult Dose for COVID-19:

0.5 mL IM ONCEComments:-This vaccine should be separated at least 2 months after the last dose of a COVID-19 vaccine.-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorizationUses:-Active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients 18 to 64 years of age with at least 1 underlying condition that puts them at high-risk for severe outcomes from COVID-19-Active immunization to prevent COVID-19 caused by SARS-CoV-2 in patients 65 years and older

Usual Pediatric Dose for COVID-19:

12 years and older: 0.5 mL IM ONCEComments:-This vaccine should be separated at least 2 months after the last dose of a COVID-19 vaccine.-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorizationUse: Active immunization to prevent COVID-19 caused by SARS-CoV-2 in patients 12 years age and older with at least 1 underlying condition that puts them at high-risk for severe outcomes from COVID-19

If you miss a dose, contact your vaccination provider or health department.

An overdose of this vaccine is not likely to happen.

Do not receive other vaccines without first getting medical advice.

Before getting this vaccine, inform your vaccination provider about all other vaccines you have had. Other medications may impact this vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Let your doctor know about all other medicines you are using.