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FDA has approved SPIKEVAX (COVID-19 Vaccine, mRNA) as a two-dose primary series for the prevention of COVID-19 in individuals ages 18 years of age and older.

The Moderna COVID-19 vaccine has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) in individuals 18 years of age and older for certain additional indications, including use as a booster. For more information regarding the authorized uses of the Moderna COVID-19 Vaccine under EUA, please refer to the Vaccine Fact Sheets.

Visit the EUA site to learn more about the authorizations for the Moderna COVID-19 Vaccine.
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The Science Behind mRNA & SPIKEVAX (COVID-19 Vaccine, mRNA)

To learn about mRNA and how spikevax works, watch our Mechanism of Action video that explains the process in a simple and engaging way.

spikevax Mechanism of Action

August 9, 20216 mins

Find a COVID-19 vaccine near you.

Looking for the spikevax COVID-19 vaccine?

Use the vaccine finder to find a location near you and make an appointment.

Want more information?

Contact Moderna using the contact details below to get more information about spikevax. If you are outside the U.S., please visit the Moderna COVID-19 Global Site or contact us.

Report Adverse Events
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Report Adverse Events

If you are experiencing a side effect following immunization, please report it to your healthcare professional, or by calling 1-866-MODERNA (1-866-663-3762).

Report Adverse Events
Illustration of clipboard being used for medical purposes

Report Adverse Events

If you are experiencing a side effect following immunization, please report it to your healthcare professional, or by calling 1-866-MODERNA (1-866-663-3762).

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Important safety information


What is SPIKEVAX (COVID-19 Vaccine, mRNA)?  

SPIKEVAX is a vaccine to help protect you against COVID-19. SPIKEVAX is for people 18 years of age and older. Vaccination with SPIKEVAX may not protect all people who receive the vaccine. 

IMPORTANT SAFETY INFORMATION

Who should not get SPIKEVAX?

You should not get SPIKEVAX if you: 

  • had a severe allergic reaction after a previous dose of SPIKEVAX (also called Moderna COVID-19 Vaccine) 

  • had a severe allergic reaction to any ingredient of this vaccine

What should you mention to your vaccination provider before you get SPIKEVAX?

Tell your vaccination provider about all of your medical conditions, including if you: 

  • have any allergies

  • had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine

  • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)

  • have a fever

  • have a bleeding disorder or are on a blood thinner

  • are immunocompromised or are on a medicine that affects your immune system

  • are pregnant or plan to become pregnant 

  • are breastfeeding

  • have received any other COVID-19 vaccine

  • have ever fainted in association with an injection

How is SPIKEVAX given? 

SPIKEVAX is given as an injection into the muscle. The SPIKEVAX vaccination series is 2 doses given 1 month apart. If you receive one dose of SPIKEVAX, you should receive a second dose of SPIKEVAX (also called Moderna COVID-19 Vaccine) 1 month later to complete the vaccination series.

What are the risks of SPIKEVAX? 

Severe allergic reactions have occurred in some people who have received SPIKEVAX (also called Moderna COVID-19 Vaccine). There is a very small chance that SPIKEVAX could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of SPIKEVAX. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Signs of a severe allergic reaction can include: 

  • Difficulty breathing

  • Swelling of your face and throat

  • A fast heartbeat

  • A rash all over your body

  • Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received SPIKEVAX (also called Moderna COVID-19 Vaccine), more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of SPIKEVAX. The chance of this happening is very low. You should seek medical attention right away if you have any of the following symptoms after receiving SPIKEVAX: 

  • Chest pain

  • Shortness of breath

  • Feelings of having a fast-beating, fluttering, or pounding heart

Side effects that have been reported in clinical trials with SPIKEVAX include: 

  • Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness

  • General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever

These may not be all the possible side effects of SPIKEVAX. 

If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. 

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. 

You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.

What if I am pregnant or breastfeeding? 

If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

Please see the SPIKEVAX Full Prescribing Information and Information for Recipients and Caregivers.

For information regarding authorized emergency uses of the Moderna COVID-19 Vaccine, please see the Fact Sheet for Recipients and Caregivers for more information.