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Aug.03.2022
 SPIKEVAX and Moderna COVID-19 Vaccine to Prevent COVID-19: Vaccine Information Fact Sheet for Recipients and Caregivers - FDA (06/17/2022)

SPIKEVAX and Moderna COVID-19 Vaccine to Prevent Coronavirus Disease: Fact Sheet for Recipients and Caregivers

FOR 12 YEARS OF AGE AND OLDER

You are being offered either SPIKEVAX (COVID-19 Vaccine, mRNA) or the Moderna COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2.

This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Moderna COVID-19 Vaccine and also includes information about the FDA-licensed vaccine, SPIKEVAX (COVID-19 Vaccine, mRNA) for use in individuals 12 years of age and older.1

The FDA-approved SPIKEVAX (COVID-19 Vaccine, mRNA) and the Moderna COVID-19 Vaccine authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably, when used according to their respective instructions for use.2

SPIKEVAX (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by ModernaTX, Inc. It is approved as a two-dose series for prevention of COVID-19 in individuals 18 years of age and older. It is also authorized under EUA to provide:
  • a two-dose primary series to individuals 12 years through 17 years of age;
  • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise;
  • a first booster dose to individuals 18 years of age and older who have completed a primary series with Moderna COVID-19 Vaccine or SPIKEVAX (COVID-19 Vaccine, mRNA);
  • a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series;
  • a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine; and
  • a second booster dose to individuals 18 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

The Moderna COVID-19 Vaccine has received EUA from FDA to provide:
  • a two-dose primary series to individuals 12 years of age and older;
  • a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise;
  • a first booster dose to the individuals 18 years of age and older who have completed a primary series with the Moderna COVID-19 Vaccine or SPIKEVAX (COVID-19 Vaccine, mRNA);
  • a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series;
  • a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine; and
  • a second booster dose to individuals 18 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

This Vaccine Information Fact Sheet contains information to help you understand the risks and benefits of SPIKEVAX (COVID-19 Vaccine, mRNA) and the Moderna COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19. Talk to your vaccination provider if you have questions.

The Moderna COVID-19 Vaccine and SPIKEVAX (COVID-19 Vaccine, mRNA) may not protect everyone.

This Fact Sheet may have been updated. For the most recent Fact Sheet, please visit www.modernatx.com/covid19vaccine-eua.

1You may receive this Vaccine Information Fact Sheet even if your child is 11 years old. Children who will turn from 11 years to 12 years of age between doses in the primary series may receive, for any dose in the primary series, either: (1) the Moderna COVID-19 Vaccine authorized for use in individuals 6 years through 11 years of age; or (2) Moderna COVID-19 Vaccine authorized for use in individuals 12 years of age and older; or (3) SPIKEVAX (COVID-19 Vaccine, mRNA).

2FDA-approved SPIKEVAX (COVID-19 Vaccine, mRNA) and one presentation of the EUA-authorized Moderna COVID-19 Vaccine (supplied in vials with red caps and labels with a light blue border) can be used interchangeably for the primary series for individuals 12 years of age and older and booster doses for individuals 18 years of age and older without presenting any safety or effectiveness concerns.

What you need to know before you get this vaccine

What is COVID-19?

COVID-19 is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

How is SPIKEVAX (COVID-19 Vaccine, mRNA) related to the Moderna COVID-19 Vaccine?

SPIKEVAX (COVID-19 Vaccine, mRNA) can be used interchangeably.

For more information on EUA, see the "What is an Emergency Use Authorization (EUA)?" section at the end of this Fact Sheet.

What should you mention to your vaccination provider before you get the vaccine?

Tell your vaccination provider about all of your medical conditions, including if you:
  • have any allergies
  • 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 another COVID-19 vaccine
  • have ever fainted in association with an injection

Who should NOT get the vaccine?

You should not get the vaccine if you:
  • had a severe allergic reaction after a previous dose of this vaccine
  • had a severe allergic reaction to any ingredient of this vaccine

What are the ingredients in the vaccine?

The Moderna COVID-19 Vaccine and SPIKEVAX (COVID-19 Vaccine, mRNA) contain the following ingredients: messenger ribonucleic acid (mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose.

How is the vaccine given?

The Moderna COVID-19 Vaccine or SPIKEVAX (COVID-19 Vaccine, mRNA) will be given to you as an injection into the muscle.

Primary Series: The vaccine is administered as a two-dose series, 1 month apart. A third primary series dose may be administered at least 1 month after the second dose to individuals with certain kinds of immunocompromise.

Booster Dose:
  • A first booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Moderna COVID-19 Vaccine or SPIKEVAX (COVID-19 Vaccine, mRNA) in individuals 18 years of age and older.
  • A first booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. Please check with your healthcare provider regarding timing of the booster dose.
  • A second booster dose of the Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
  • A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with certain kinds of immunocompromise.

Has the vaccine been used before?

Yes. In clinical trials, approximately 30,000 individuals 12 years of age and older have received at least 1 dose of the vaccine. Data from these clinical trials supported the Emergency Use Authorization of Moderna COVID-19 Vaccine and the approval of SPIKEVAX (COVID-19 Vaccine, mRNA). Millions of individuals have received the vaccine under EUA since December 18, 2020.

What are the benefits of the vaccine?

The vaccine has been shown to prevent COVID-19. The duration of protection against COVID-19 is currently unknown.

What are the risks of the vaccine?

There is a remote chance that the vaccine 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 the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
  • Difficulty breathing
  • Swelling of your face and throat
  • A fast heartbeat
  • A bad 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 the 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 the vaccine. The chance of having this occur is very low. You should seek medical attention right away if you have any of the following symptoms after receiving 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 the vaccine 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

Side effects that have been reported during post-authorization use of the vaccine include:
  • Severe allergic reactions
  • 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 the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.

What should I do about side effects?

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.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include either "SPIKEVAX (COVID-19 Vaccine, mRNA)" or "Moderna COVID-19 Vaccine EUA," as appropriate, in the first line of box #18 of the report form.

In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663-3762).

You may also be given an option to enroll in v-safe. V-safe is a voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.

What if I decide not to get SPIKEVAX (COVID-19 Vaccine, mRNA) or the Moderna COVID-19 Vaccine?

Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard medical care.

Are other choices available for preventing COVID-19 besides SPIKEVAX (COVID-19 Vaccine, mRNA) or the Moderna COVID-19 Vaccine?

Another choice for preventing COVID-19 is COMIRNATY (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. Other vaccines to prevent COVID-19 may be available under EUA.

Can I receive SPIKEVAX (COVID-19 Vaccine, mRNA) or the Moderna COVID-19 Vaccine at the same time as other vaccines?

Data have not yet been submitted to FDA on administration of SPIKEVAX (COVID-19 Vaccine, mRNA) or the Moderna COVID-19 Vaccine at the same time as other vaccines. If you are considering receiving SPIKEVAX (COVID-19 Vaccine, mRNA) or the Moderna COVID-19 Vaccine with other vaccines, discuss your options with your healthcare provider.

What if I am immunocompromised?

If you are immunocompromised, you may receive a third primary series dose of the vaccine. The third dose may still not provide full immunity to COVID-19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID-19. In addition, after you received a first booster dose, you may receive a second booster dose of the vaccine if you are 18 years of age and older. Your close contacts should be vaccinated as appropriate.

What if I am pregnant or breastfeeding?

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

Will the vaccine give me COVID-19?

No. The vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.

Keep your vaccination card

When you receive your first dose, you will get a vaccination card to show you when to return for your next dose(s) of the vaccine. Remember to bring your card when you return.

Additional information

QR code with link to https://www.modernatx.com/covid19vaccine-eua/

If you have questions, visit the website or call the telephone number provided below.

To access the most recent Fact Sheets, please scan the QR code provided below.

How can I learn more?

Where will my vaccination information be recorded?

The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. This will ensure that you receive the same vaccine when you return for the second dose. For more information about IISs, visit: https://www.cdc.gov/vaccines/programs/iis/about.html.

Can I be charged an administration fee for receipt of the COVID-19 vaccine?

No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients).

Where can I report cases of suspected fraud?

Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.

What is the Countermeasures Injury Compensation Program?

The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.

What is an Emergency Use Authorization (EUA)?

QR code. Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems.

An EUA is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. An EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. A product authorized for emergency use has not undergone the same type of review by FDA as an FDA approved product.

FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic.

An EUA is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used).

Moderna US, Inc.

Cambridge, MA 02139

©2022 ModernaTX, Inc. All rights reserved.

Patent(s): www.modernatx.com/patents

Revised: June/17/2022

Revised: June/17/2022

This information is not intended to replace advice given to you by your health care provider. Make sure you discuss any questions you have with your health care provider.

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