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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 18 years of age and older.
The FDA-approved SPIKEVAX (COVID-19 Vaccine, mRNA) and the Moderna COVID-19 Vaccine authorized for Emergency Use Authorization (EUA) for individuals 18 years of age and older can be used interchangeably, when used according to their respective instructions for use.1
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.
1FDA-approved SPIKEVAX (COVID-19 Vaccine, mRNA) and one presentation of the EUA-authorized Moderna COVID-19 Vaccine (supplied in vials with red caps) can be used interchangeably for the primary series and booster doses without presenting any safety or effectiveness concerns. One presentation of the Moderna COVID-19 Vaccine (supplied in vials with dark blue caps) is authorized for emergency use to provide booster doses only. The booster dose only presentation of the Moderna COVID-19 Vaccine is not authorized to provide a primary series dose. SPIKEVAX (COVID-19 Vaccine, mRNA) or the two EUA-authorized presentations of Moderna COVID-19 Vaccine (supplied in vials with red caps or vials with dark blue caps) can be used to provide a booster dose(s), and the choice of presentation does not present any safety or effectiveness concerns.
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?
Who should NOT get the 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, one month apart. A third primary series dose may be administered at least one month after the second dose to individuals with certain kinds of immunocompromise.
Has the vaccine been used before?
Yes. In clinical trials, approximately 15,400 individuals 18 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?
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 new 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 Emergency Use Authorization.
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.
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.
If you have questions, visit the website or call the telephone number provided below.
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.
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).
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.
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.
An Emergency Use Authorization (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.
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.
This EUA for the Moderna COVID-19 Vaccine and SPIKEVAX (COVID-19 Vaccine, mRNA) will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.
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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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