This site is for US consumers.
This site is for US consumers.Prescribing info
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WHEN PROTECTION IS NEEDED AGAINST NEW COVID-19 VARIANTS, SPIKEVAX UPDATES.*

Moderna's 2024-2025 COVID-19 vaccine formulation has been updated to protect against changing variants, like KP.2, following ACIP recommendation. Talk to your healthcare provider or stop by your local pharmacy and ask about Spikevax.

* Update is consistent with VRBPAC guidance.

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Why Spikevax?

The pandemic is over, but people are still at risk of severe COVID-19. Vaccinating with Spikevax can help keep you protected.

COVID-19 is still here.

COVID-19 vaccination is recommended by ACIP for all people aged ≥6 months.1,2*

Spikevax (COVID-19 Vaccine, mRNA) 2024-2025

Formula is now available.

Spikevax (COVID-19 Vaccine, mRNA) 2024-2025 Formula is an updated vaccine indicated for active
immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.1

Search to find a vaccination site near you, or talk to your healthcare provider.

We're here to help!

If you have questions or would like more information:

Email

For medical inquiries:

WeCare@modernatx.com

Phone

1-866-MODERNA (1-866-663-3762)

8:00 AM - 8:00 PM ET

Monday - Friday (closed holidays)

About Moderna

www.ModernaTx.com

*Based on manufacturers' dosing guidelines.


What is SPIKEVAX and Important Safety Information

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

SPIKEVAX is a vaccine to protect you against COVID-19. SPIKEVAX is for people 12 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 or a Moderna COVID-19 vaccine
  • a severe allergic reaction to any ingredient of these vaccines
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 a single dose injected into the muscle.

What are the risks of SPIKEVAX?

Severe allergic reactions have occurred in some people who have received SPIKEVAX and Moderna COVID-19 vaccines. 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 1 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:

  • Trouble 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 mRNA COVID-19 vaccines, including SPIKEVAX and Moderna COVID-19 vaccines. Myocarditis and pericarditis following SPIKEVAX and Moderna COVID19 vaccines have occurred most commonly in males 18 years through 24 years of age. In most of these individuals, symptoms began within a few days following vaccination. The chance of this happening is very low. You should seek medical attention right away if you or your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:

  • 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 and Moderna COVID-19 vaccines 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, fever, and rash

Other side effects that have been reported include:

  • Severe allergic reactions
  • Urticaria (itchy rash/hives)
  • Myocarditis (inflammation of the heart muscle)
  • Pericarditis (inflammation of the lining outside the heart)
  • Fainting in association with injection of the vaccine

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

Ask your healthcare provider about any side effects that concern you.

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

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

What if I am pregnant or breastfeeding?

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

Please click for SPIKEVAX Full Prescribing Information and Information for Recipients and Caregivers.


References
  1. Regan JJ, et al. MMWR Morb Mortal Wkly Rep. 2023;72:1140-1146.

  2. CDC. Accessed April 10, 2024.
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