COVID-19 (12y+) vaccine Spikevax (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 person to person 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.

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

Spikevax vaccine is for people:

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

The 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, the COVID-19 vaccine may not protect every person from the disease.

Read all vaccine information sheets provided to you.

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

Spikevax COVID-19 vaccine for people at least 12 years old is given:

• unvaccinated individuals: a single dose of Spikevax COVID-19 vaccine;
• people who have already received a dose of any COVID-19 vaccine: a single dose of Spikevax 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 extra doses.

Continue to follow 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 frequently touch, and not sharing personal items with others.

Receiving a COVID-19 vaccine will not cause you to test positive on a coronavirus test. However, after your body develops immunity to COVID-19, you might test positive on an antibody test (which checks for immunity in the body from previous exposure to coronavirus).

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

Getting infected with COVID-19 can be much more harmful to your health than getting this vaccine.

You should not receive this vaccine if you have had a severe allergic reaction after a previous dose of SPIKEVAX, MNEXSPIKE, Moderna COVID-19 vaccine, or if you have had a severe allergic reaction to any ingredient in this vaccine.

If you are infected with COVID-19, are waiting for testing results, or are exposed to someone infected with COVID-19: you may not be able to receive this vaccine until you have no symptoms and/or your required quarantine period has ended. Receiving this vaccine will not make you less contagious to other people if you are infected with COVID-19 but you have no symptoms.

Ask your doctor if you are unsure about any COVID-19 treatments you 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 caused by disease or by using certain medicines (this vaccine may not be as effective if you are immunosuppressed);
• are pregnant, plan to become pregnant, or breastfeeding;
• have received any other COVID-19 vaccine or if you are scheduled to receive a vaccine; or
• have fainted after receiving an injection.

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

The vaccination provider may want to observe 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 a reaction occurs right after receiving the vaccine.

You should not receive this vaccine if you had an allergic reaction to any dose of the COVID-19 vaccine. The doctor or vaccination provider will decide if you can safely receive this vaccine.

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

Some people (most often males aged 12 to 24 years) who received this vaccine experienced inflammation of the heart muscle or the lining around the heart after vaccination, usually within the first week. Seek medical attention right away if you have the following symptoms, especially within the first two weeks:

• chest pain;
• shortness of breath; or
• fast or pounding heartbeats, fluttering in your chest.

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

• pain, redness, hardness, or swelling where the injection was given;
• fever, chills, nausea, vomiting, feeling tired;
• swelling or tenderness under the arm where the injection was given; or
• headache, muscle pain, joint pain.

This is not a complete list of side effects; 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 Prophylaxis:

Irrespective of COVID-19 vaccination status: 0.5 mL IM as a single dose-If previously vaccinated with any COVID-19 vaccine: 0.5 mL IM as a single dose, administered at least 2 months after the last dose of COVID-19 vaccineComments:-This vaccine is approved for use in adults who are 18 through 64 years of age with at least 1 underlying condition that places them at high risk for severe outcomes from COVID-19.Use: For active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Usual Geriatric Dose for COVID-19 Prophylaxis:

65 years and older:-Irrespective of COVID-19 vaccination status: 0.5 mL IM as a single dose---If previously vaccinated with any COVID-19 vaccine: 0.5 mL IM as a single dose, administered at least 2 months after the last dose of COVID-19 vaccineUse: For active immunization to prevent COVID-19 caused by SARS-CoV-2

Usual Pediatric Dose for COVID-19 Prophylaxis:

12 years and older:-Irrespective of COVID-19 vaccination status: 0.5 mL IM as a single dose---If previously vaccinated with any COVID-19 vaccine: 0.5 mL IM as a single dose, administered at least 2 months after the last dose of COVID-19 vaccineComments:-This vaccine is approved for use in patients who are 6 months through 17 years of age with at least 1 underlying condition that places them at high risk for severe outcomes from COVID-19.---This formulation is intended for patients 12 years and older.---For dosing of infants and children (aged 6 months through 11 years), consult the DOSAGE section of SARS-CoV-2 (COVID-19) mRNA-LNP vaccine (cvx 311).Use: For active immunization to prevent COVID-19 caused by SARS-CoV-2

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

An overdose of this vaccine is unlikely to happen.

Do not receive other vaccines without first consulting a healthcare professional.

Before getting this vaccine, inform your vaccination provider about all other vaccines you have received. 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.