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COVID-19 (12y+) vaccine Spikevax (2023-2024)

Generic name: COVID-19 (12y+) vaccine Spikevax (2023-2024) [ KOE-vid-VAX-een ]
Brand name: Spikevax (2023-2024) PF (cvx 312)
Dosage form: intramuscular suspension (preservative-free 50 mcg/0.5 mL)
Drug class: Viral vaccines

Medically reviewed by Drugs.com on Jan 30, 2024. 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.

The COVID-19 vaccine is used to help prevent COVID-19 caused by SARS-CoV-2.

The US Food and Drug Administration (FDA) has approved the Spikevax vaccine for active immunization to prevent COVID-19 in people 12 years of age and older.

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, rash, dizziness, weakness, fast heartbeats, difficult breathing, swelling of the face, lips, tongue, or throat.

The vaccination provider may want to watch you for a short time after the shot, 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 the first shot 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 days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have:

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

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.

Sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 312) side effects (more detail)

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 or Moderna COVID-19 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:

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this vaccine on the baby.

Tell your doctor if you are pregnant or breastfeeding.

How is this vaccine given?

Read all vaccine information sheets provided to you. Follow the label directions or your vaccination provider's instructions.

The Spikevax COVID-19 vaccine is given in people at least 12 years old as a single injection (shot) into a muscle.

For people who have already received a dose of any COVID-19 vaccine: a single dose of Spikevax COVID-19 vaccine is given 2 months after the last dose of any COVID-19 vaccine.

You will receive a reminder card showing the date and type of each injection. Take this card with you each time you receive a COVID-19 vaccine.

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 your body develops immunity to COVID-19, you could test positive on an antibody test (a test to detect immunity in your 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/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html

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

Usual Adult Dose for COVID-19:

12 years and older:
Dark blue cap/label multidose vial (50 mcg/0.5 mL): 0.5 mL IM once, administered at least 2 months after the last dose of vaccine

Comments:
-This drug is not approved by the US FDA to prevent COVID-19. The US FDA has issued a BLA for the use of this drug to prevent COVID-19.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Use: For active immunization to prevent SARS-CoV-2, including the COVID-19 Omicron (XBB.1.5) virus strain variant

Usual Pediatric Dose for COVID-19:

For investigational use only

12 years and older:
Dark blue cap/label multidose vial (50 mcg/0.5 mL): 0.5 mL IM once, administered at least 2 months after the last dose of vaccine.

Comments:
-This drug is not approved by the US FDA to prevent COVID-19. The US FDA has issued an EUA for the use of this drug to prevent COVID-19.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Use: For active immunization to prevent SARS-CoV-2, including the COVID-19 Omicron (XBB.1.5) virus strain variant

Detailed Sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 312) dosage information

What happens if I miss a dose?

Be sure to receive all recommended doses of COVID-19 vaccine or you may not be fully protected. 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.

Sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 312) drug interactions (more detail)

More about sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 312)

Patient resources

Other brands

Spikevax (2023-2024) PF (cvx 312)

Related treatment guides

Further information

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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