COVID-19 (12y+) vaccine Spikevax (2025-2026)

Generic name: COVID-19 (12y+) vaccine Spikevax (2025-2026)
Brand names: Spikevax (2025-2026) PF (cvx 312), Spikevax (2023-2024) PF (cvx 312), Spikevax (2024-2025) PF (cvx 312)
Dosage form: intramuscular suspension (preservative-free 50 mcg/0.5 mL)
Drug class: Viral vaccines

Medically reviewed by Drugs.com on Aug 26, 2025. Written by Cerner Multum.

What is the COVID-19 vaccine?

COVID-19 is a serious disease caused by a coronavirus called SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 is spread from person to person through the air.

COVID-19 can affect your lungs or other organs. Symptoms may be mild or serious and 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 used to prevent COVID-19 in people:

• age 65 and older; or

• 12 years through 64 years of age and 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.

This vaccine side effects

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

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

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

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

Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart after receiving this vaccine, but the risk of this side effect is very low. 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 COVID-19 (12y+) vaccine Spikevax may include:

• fever, chills, nausea, vomiting, feeling tired;

• pain, redness, hardness, or swelling where the injection was given;

• 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 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

Related/similar drugs

Warnings

Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine.

Before taking this medicine

You should not receive this vaccine if you've ever had a severe allergic reaction to Spikevax, Moderna COVID-19 vaccine, or if you have or have ever had:

• an allergy to any of the ingredients of 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 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.

How is this vaccine given?

Read all vaccine information sheets provided to you.

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

Spikevax COVID-19 vaccine in 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 determine whether an immunocompromised person needs additional doses.

Keep using infection control methods when you are in public or around others who may not have been vaccinated. This includes social distancing, hand-washing, using protective face covering, disinfecting surfaces you touch a lot, and not sharing personal items with others.

Receiving a COVID-19 vaccine will not cause you to test positive on a coronavirus test. However, once the body develops immunity to COVID-19, you could test positive on an antibody test (a test to detect immunity in the body from previous exposure to coronavirus).

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

COVID-19 (12y+) vaccine Spikevax dosing information

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 vaccine

Comments:
-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 vaccine

Use: 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 vaccine

Comments:
-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

What happens if I miss a dose?

Contact your vaccination provider or health department if you miss a dose.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid after receiving this vaccine?

Avoid receiving other vaccines without first seeking medical advice.

What other drugs will affect this vaccine?

Before receiving this vaccine, tell your vaccination provider about all other vaccines you have received. Other drugs may affect this vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Popular FAQ

Further information

• Your vaccination provider, pharmacist, or doctor can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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