PRIMARY SERIES For 12 Years and Older

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, MODERNA COVID-19 VACCINE, for active immunization to prevent COVID-19 in individuals 6 months of age and older.

This Fact Sheet pertains only to Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a red cap and a label with a light blue border which is authorized for use to provide:

•

a two-dose primary series to individuals 12 years of age and older; and

•

a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.1

SPIKEVAX (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by ModernaTX, Inc. that is indicated for active immunization to prevent COVID-19 in individuals 18 years of age and older.2 It is approved for use as a two-dose primary series for the prevention of COVID-19 in individuals 18 years of age and older. It is also authorized for emergency use to provide:

•

a two-dose primary series to individuals 12 years through 17 years of age; and

•

a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

SPIKEVAX (COVID-19, mRNA) and Moderna COVID-19 Vaccine supplied in multiple-dose vials with a red cap and a label with a light blue border intended for use in individuals 12 years of age and older should not be used in individuals 6 months through 11 years of age because of the potential for vaccine administration errors, including dosing errors.3,4

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1

Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

2

As described in the Letter of Authorization, the FDA-approved SPIKEVAX (COVID-19 Vaccine, mRNA) and the EUA-authorized presentation of the Moderna COVID-19 Vaccine supplied in multiple-dose vials with red caps and labels with a light blue border can be used interchangeably to provide primary series doses to individuals 12 years of age and older without presenting any safety or effectiveness concerns.

3

Notwithstanding the age limitations for use of the different presentations of the Moderna COVID-19 Vaccine, individuals 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 (each 0.5 mL dose containing 50 mcg mRNA) supplied in multiple-dose vials with dark blue caps and labels with a purple border stating “BOOSTER DOSES ONLY”; (2) SPIKEVAX (COVID-19 Vaccine, mRNA) or the Moderna COVID-19 Vaccine authorized for use in individuals 12 years of age and older (each 0.5 mL dose containing 100 mcg mRNA) supplied in multiple-dose vials with red caps and labels with a light blue border; or (3) the Moderna COVID-19 Vaccine authorized for use in individuals 6 years through 11 years of age (each 0.5 mL dose containing 50 mcg mRNA) supplied in multiple-dose vials with dark blue caps and labels with a teal border (currently not available). The multiple-dose vials with dark blue caps and labels with a purple border are authorized to provide 0.5 mL primary series doses for individuals 6 years through 11 years of age.

4

For primary vaccination of individuals 6 months through 5 years of age and 6 years through 11 years of age, refer to the respective Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine.

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of the Moderna COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FOR MODERNA COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting requirements.

The Moderna COVID-19 Vaccine is a suspension for intramuscular injection.

Primary Series5

Each primary series dose of the Moderna COVID-19 Vaccine for individuals 12 years of age and older is 0.5 mL.

The Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a red cap and a label with a light blue border is administered as a primary series of two doses (0.5 mL each) 1 month apart to individuals 12 years of age or older.

A third primary series dose (0.5 mL) of the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a red cap and a label with a light blue border is authorized for administration at least 1 month following the second dose to individuals at least 12 years of age with certain kinds of immunocompromise.

See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.modernatx.com/covid19vaccine-eua.

For information on clinical trials that are testing the use of the Moderna COVID-19 Vaccine for active immunization against COVID-19, please see www.clinicaltrials.gov.

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5

A primary series dose of SPIKEVAX (COVID-19 Vaccine, mRNA) is 0.5 mL.

DESCRIPTION OF COVID-19

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, 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 and body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

DOSAGE AND ADMINISTRATION

CONTRAINDICATION

Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine (see Full EUA Prescribing Information).

WARNINGS

Management of Acute Allergic Reactions

Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine.

Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Myocarditis and Pericarditis

Postmarketing data with Moderna COVID-19 Vaccine demonstrate increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following the second dose of the primary series. The observed risk is highest in males 18 through 24 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae.

Some, but not all, observational analyses of postmarketing data suggest that there may be an increased risk of myocarditis and pericarditis in males under 40 years of age following the second dose of the Moderna COVID-19 Vaccine relative to other authorized or approved mRNA COVID-19 vaccines.

The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Moderna COVID-19 Vaccine.

Limitations of Vaccine Effectiveness

The Moderna COVID-19 Vaccine may not protect all vaccine recipients.

ADVERSE REACTIONS

Adverse Reactions in Clinical Trials

Adverse reactions reported in clinical trials following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, erythema at the injection site, and rash. (See Full EUA Prescribing Information)

Adverse Reactions in Post-Authorization Experience

Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, syncope, and urticaria have been reported following administration of the Moderna COVID-19 Vaccine during post-authorization use.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.

USE WITH OTHER VACCINES

There is no information on the co-administration of the Moderna COVID-19 Vaccine with other vaccines.

INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS

As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the “Vaccine Information Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website www.modernatx.com/covid19vaccine-eua to obtain the Fact Sheet) prior to the individual receiving each dose of the Moderna COVID-19 Vaccine, including:

•

FDA has authorized the emergency use of the Moderna COVID-19 Vaccine, which is not an FDA-approved vaccine.

•

There is an option to accept or refuse the Moderna COVID-19 Vaccine.

•

The significant known and potential risks and benefits of the Moderna COVID-19 Vaccine, and the extent to which such risks and benefits are unknown.

•

Information about available alternative vaccines and the risks and benefits of those alternatives.

For information on clinical trials that are evaluating the use of the Moderna COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov.

Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of Moderna COVID-19 Vaccine.

Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate 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 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, visit: www.cdc.gov/vsafe.

MANDATORY REQUIREMENTS FOR MODERNA COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION7

In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of the Moderna COVID-19 Vaccine, the following items are required. Use of unapproved Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met):

1.

The Moderna COVID-19 Vaccine is authorized for use in individuals 6 months of age and older.
 

2.

The vaccination provider must communicate to the individual receiving the Moderna COVID-19 Vaccine or their caregiver information consistent with the “Vaccine Information Fact Sheet for Recipients and Caregivers” prior to the individual receiving the Moderna COVID-19 Vaccine.
 

3.

The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system.
 

4.

The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):

•

vaccine administration errors whether or not associated with an adverse event,

•

serious adverse events* (irrespective of attribution to vaccination),

•

cases of myocarditis,

•

cases of pericarditis,

•

cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and

•

cases of COVID-19 that result in hospitalization or death.

 

 

 

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Moderna COVID-19 Vaccine EUA” in the description section of the report.
 

5.

The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of myocarditis, cases of pericarditis, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of the Moderna COVID-19 Vaccine to recipients.
 
*Serious adverse events are defined as:

•

Death;

•

A life-threatening adverse event;

•

Inpatient hospitalization or prolongation of existing hospitalization;

•

A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;

•

A congenital anomaly/birth defect;

•

An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.

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7

Vaccination providers administering SPIKEVAX (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

OTHER ADVERSE EVENT REPORTING TO VAERS AND MODERNATX, INC.

Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

To the extent feasible, report adverse events to ModernaTX, Inc. using the contact information below or by providing a copy of the VAERS form to ModernaTX, Inc.

Email	Fax number	Telephone number
ModernaPV@modernatx.com	1-866-599-1342	1-866-MODERNA (1-866-663-3762)

ADDITIONAL INFORMATION

For general questions, visit the website or call the telephone number provided below.

To access the most recent Moderna COVID-19 Vaccine Fact Sheets, please scan the QR code or visit the website provided below.

Website	Telephone number
www.modernatx.com/covid19vaccine-eua	1-866-MODERNA (1-866-663-3762)

AVAILABLE ALTERNATIVES

SPIKEVAX (COVID-19 Vaccine, mRNA) and COMIRNATY (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. There may be clinical trials or availability under EUA of other COVID-19 vaccines.

FEDERAL COVID-19 VACCINATION PROGRAM

This vaccine is being made available for emergency use exclusively through the CDC COVID-19 Vaccination Program (the Vaccination Program). Healthcare providers must enroll as providers in the Vaccination Program and comply with the provider requirements. Vaccination providers may not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket charge for administration. 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). For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html.

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.

AUTHORITY FOR ISSUANCE OF THE EUA

The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 Pandemic. In response, the FDA has issued an EUA for the unapproved product, Moderna COVID-19 Vaccine, and for certain uses of FDA-approved SPIKEVAX (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19.

FDA issued this EUA, based on ModernaTX, Inc.’s request and submitted data.

For the authorized uses, although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Moderna COVID-19 Vaccine and SPIKEVAX (COVID-19 Vaccine, mRNA) may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information.

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.

For additional information about Emergency Use Authorization, visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

COUNTERMEASURES INJURY COMPENSATION PROGRAM

The Countermeasures Injury Compensation Program (CICP) is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. For more information about CICP regarding the vaccines to prevent COVID-19, visit http://www.hrsa.gov/cicp, email cicp@hrsa.gov, or call: 1-855-266-2427.

Moderna US, Inc.
Cambridge, MA 02139

©2022 ModernaTX, Inc. All rights reserved.
Patent(s): www.modernatx.com/patents
Revised: Dec/8/2022

END SHORT VERSION FACT SHEET

Long Version (Full EUA Prescribing Information) Begins On Next Page

FULL EMERGENCY USE AUTHORIZATION (EUA)
PRESCRIBING INFORMATION

MODERNA COVID-19 VACCINE

FULL EUA PRESCRIBING INFORMATION: CONTENTS*	11 USE IN SPECIFIC POPULATIONS
1 AUTHORIZED USE	11.1 Pregnancy
2 DOSAGE AND ADMINISTRATION	11.2 Lactation
2.1 Preparation for Administration	11.3 Pediatric Use
2.2 Administration	11.4 Geriatric Use
2.3 Dose and Schedule	11.5 Use in Immunocompromised Individuals
3 DOSAGE FORMS AND STRENGTHS	13 DESCRIPTION
4 CONTRAINDICATIONS	14 CLINICAL PHARMACOLOGY
5 WARNINGS AND PRECAUTIONS	14.1 Mechanism of Action
5.1 Management of Acute Allergic Reactions	18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA 18.1 Efficacy of Two-Dose Primary Series in Participants 18 Years of Age and Older 18.2 Effectiveness of Two-Dose Primary Series in Participants12 Years Through 17 Years of Age 18.3 Immunogenicity of a Third Primary Series Dose in Individuals with Certain Kinds of Immunocompromise 19 HOW SUPPLIED/STORAGE AND HANDLING 20 PATIENT COUNSELING INFORMATION 21 CONTACT INFORMATION *Sections or subsections omitted from the full prescribing information are not listed
5.2 Myocarditis and Pericarditis
5.3 Syncope
5.4 Altered Immunocompetence
5.5 Limitations of Vaccine Effectiveness
6 OVERALL SAFETY SUMMARY
6.1 Clinical Trials Experience
6.2 Post-Authorization Experience
8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS
10 DRUG INTERACTIONS

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

1 AUTHORIZED USE

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

This EUA Prescribing Information pertains only to Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a red cap and a label with a light blue border which is authorized for use for primary series doses in individuals 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

The storage, preparation, and administration information in this Prescribing Information apply to the Moderna COVID-19 Vaccine, supplied in a multiple-dose vials with red caps and labels with a light blue border, which is authorized for use for primary series doses in individuals 12 years of age and older.

3 DOSAGE FORMS AND STRENGTHS

Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a red cap and a label with a light blue border is a suspension for injection.

•

Each primary series dose is 0.5 mL.

4 CONTRAINDICATIONS

Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine [see Description (13)].

5 WARNINGS AND PRECAUTIONS

6 OVERALL SAFETY SUMMARY

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Moderna COVID-19 Vaccine.10 To the extent feasible, provide a copy of the VAERS form to ModernaTX, Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and ModernaTX, Inc.

Primary Series

In a clinical study, the adverse reactions in participants 18 years of age and older following administration of the primary series included pain at the injection site (92.0%), fatigue (70.0%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23.0%), axillary swelling/tenderness (19.8%), fever (15.5%), swelling at the injection site (14.7%), and erythema at the injection site (10.0%).

In a clinical study, the adverse reactions in participants 12 years through 17 years of age following administration of the primary series included pain at the injection site (97.2%), headache (78.4%), fatigue (75.2%), myalgia (54.3%), chills (49.1%), arthralgia (34.6%), axillary swelling/tenderness (34.6%), nausea/vomiting (29.3%), swelling at the injection site (27.7%), erythema at the injection site (25.8%), and fever (13.7%).

Post-Authorization Experience

Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, syncope, and urticaria have been reported following administration of the Moderna COVID-19 Vaccine outside of clinical trials.

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10

 Vaccination providers administering SPIKEVAX (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS12

See Overall Safety Summary (Section 6) for additional information.

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for the MANDATORY reporting of the listed events following Moderna COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS)

•

Vaccine administration errors whether or not associated with an adverse event

•

Serious adverse events* (irrespective of attribution to vaccination)

•

Cases of myocarditis

•

Cases of pericarditis

•

Cases of Multisystem Inflammatory Syndrome (MIS) in adults and children

•

Cases of COVID-19 that results in hospitalization or death

*Serious Adverse Events are defined as:

•

Death;

•

A life-threatening adverse event;

•

Inpatient hospitalization or prolongation of existing hospitalization;

•

A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;

•

A congenital anomaly/birth defect;

•

An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods:

•

Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or

•

If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need additional help submitting a report, you may call the VAERS toll-free information line at 1-800-822-7967 or send an email to info@vaers.org.

IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible. Information to include:

•

Patient demographics (e.g., patient name, date of birth)

•

Pertinent medical history

•

Pertinent details regarding admission and course of illness

•

Concomitant medications

•

Timing of adverse event(s) in relationship to administration of Moderna COVID-19 Vaccine

•

Pertinent laboratory and virology information

•

Outcome of the event and any additional follow-up information if it is available at the time of the VAERS report. Subsequent reporting of follow-up information should be completed if additional details become available.

The following steps are highlighted to provide the necessary information for safety tracking:

1.

In Box 17, provide information on Moderna COVID-19 Vaccine and any other vaccines administered on the same day; and in Box 22, provide information on any other vaccines received within one month prior.

2.

In Box 18, description of the event:

a.

Write “Moderna COVID-19 Vaccine EUA” as the first line

b.

Provide a detailed report of vaccine administration error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved vaccine. Please see information to include listed above.

3.

Contact information:

a.

In Box 13, provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report.

b.

In Box 14, provide the name and contact information of the best doctor/healthcare professional to contact about the adverse event.

c.

In Box 15, provide the address of the facility where vaccine was given (NOT the healthcare provider’s office address).

Other Reporting Instructions

Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

To the extent feasible, report adverse events to ModernaTX, Inc. using the contact information below or by providing a copy of the VAERS form to ModernaTX, Inc.

Email	Fax number	Telephone number
ModernaPV@modernatx.com	1-866-599-1342	1-866-MODERNA (1-866-663-3762)

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 Vaccination providers administering SPIKEVAX (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

10 DRUG INTERACTIONS

There are no data to assess the concomitant administration of the Moderna COVID-19 Vaccine with other vaccines.

11 USE IN SPECIFIC POPULATIONS

13 DESCRIPTION

Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular injection.

Each 0.5 mL dose of Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a red cap and a label with a light blue border contains 100 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Wuhan-Hu-1 strain. Each 0.5 mL dose of the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a red cap and a label with a light blue border contains the following ingredients: a total lipid content of 1.93 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.31 mg tromethamine, 1.18 mg tromethamine hydrochloride, 0.043 mg acetic acid, 0.20 mg sodium acetate trihydrate, and 43.5 mg sucrose.

Moderna COVID-19 Vaccine does not contain a preservative.

The vial stoppers are not made with natural rubber latex.

14 CLINICAL PHARMACOLOGY

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

19 HOW SUPPLIED/STORAGE AND HANDLING

The information in this section applies to the Moderna COVID-19 Vaccine that is supplied in multiple-dose vials with red caps and labels with a light blue border. These multiple-dose vials are supplied as follows:

NDC 80777-273-99     Carton of 10 multiple-dose vials, each vial containing 5.5 mL
NDC 80777-273-98     Carton of 10 multiple-dose vials, each vial containing 7.5 mL

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Frozen Storage

Store frozen between -50°C to -15°C (-58°F to 5°F).

Storage after Thawing

•

Storage at 2°C to 8°C (36°F to 46°F):

o

Vials may be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days prior to first use.

o

Vials should be discarded 12 hours after the first puncture.

•

Storage at 8°C to 25°C (46°F to 77°F):

o

Vials may be stored between 8°C to 25°C (46°F to 77°F) for a total of 24 hours.

o

Vials should be discarded 12 hours after the first puncture.

o

Total storage at 8°C to 25°C (46°F to 77°F) must not exceed 24 hours.

Do not refreeze once thawed.

Thawed vials can be handled in room light conditions.

Transportation of Thawed Vials at 2°C to 8°C (36°F to 46°F)

If transport at -50°C to -15°C (-58°F to 5°F) is not feasible, available data support transportation of one or more thawed vials for up to 12 hours at 2°C to 8°C (36°F to 46°F) when shipped using shipping containers which have been qualified to maintain 2°C to 8°C (36°F to 46°F) and under routine road and air transport conditions with shaking and vibration minimized. Once thawed and transported at 2°C to 8°C (36°F to 46°F), vials should not be refrozen and should be stored at 2°C to 8°C (36°F to 46°F) until use.

20 PATIENT COUNSELING INFORMATION

Advise the recipient or caregiver to read the Vaccine Information Fact Sheet for Recipients and Caregivers.

The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html.

21 CONTACT INFORMATION

For general questions, send an email or call the telephone number provided below.

Email	Telephone number
medinfo@modernatx.com	1-866-MODERNA (1-866-663-3762)

This EUA Prescribing Information may have been updated. For the most recent Full EUA Prescribing Information, please visit www.modernatx.com/covid19vaccine-eua.

Moderna US, Inc.
Cambridge, MA 02139

©2022 ModernaTX, Inc. All rights reserved.
Patent(s): www.modernatx.com/patents
Revised: Dec/8/2022

VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS

ABOUT SPIKEVAX (COVID-19 VACCINE, mRNA), MODERNA COVID-19 VACCINE, AND MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

FOR 6 YEARS OF AGE AND OLDER

You or your child are being offered either SPIKEVAX (COVID-19 Vaccine, mRNA), Moderna COVID-19 Vaccine, or Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Moderna COVID-19 Vaccine, Bivalent, 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 the authorized Moderna COVID-19 Vaccine, Bivalent for use in individuals 6 years of age and older, and also includes information about the FDA-licensed vaccine, SPIKEVAX (COVID-19 Vaccine, mRNA) for use in individuals 12 years of age and older.13

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.14

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:

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a two-dose primary series to individuals 12 years through 17 years of age; and

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a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.

The Moderna COVID-19 Vaccine has received EUA from FDA to provide:

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a two-dose primary series to individuals 6 years of age and older; and

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a third primary series dose to individuals 6 years of age and older with certain kinds of immunocompromise.

Moderna COVID-19 Vaccine, Bivalent has received EUA from FDA to provide either:

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a single booster dose to individuals 6 years of age and older at least 2 months after completion of primary vaccination with any authorized or approved COVID-19 vaccine; or

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a single booster dose to individuals 6 years of age and older at least 2 months after receipt of the most recent booster dose with any authorized or approved monovalent15 COVID-19 vaccine.

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

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

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

WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD 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 ARE SPIKEVAX (COVID-19 VACCINE, mRNA), MODERNA COVID-19 VACCINE, AND MODERNA COVID-19 VACCINE, BIVALENT RELATED?

SPIKEVAX (COVID-19 Vaccine, mRNA) and Moderna COVID-19 Vaccine can be used interchangeably.16 Moderna COVID-19 Vaccine, Bivalent is made in the same way as SPIKEVAX and Moderna COVID-19 Vaccine, but it also contains an Omicron component to help prevent COVID-19 caused by the Omicron variant of SARS-CoV-2.

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 THE VACCINATION PROVIDER BEFORE YOU OR YOUR CHILD GET ANY OF THESE VACCINES?

Tell the vaccination provider about all of your or your child’s medical conditions, including if you or your child:

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have any allergies

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

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have a fever

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have a bleeding disorder or are on a blood thinner

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are immunocompromised or are on a medicine that affects your or your child’s immune system

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are pregnant or plan to become pregnant

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are breastfeeding

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have received another COVID-19 vaccine

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have ever fainted in association with an injection

WHO SHOULD NOT GET SPIKEVAX (COVID-19 VACCINE, mRNA), MODERNA COVID-19 VACCINE, OR MODERNA COVID-19 VACCINE, BIVALENT?

You or your child should not get any of these vaccines if you or your child:

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had a severe allergic reaction after a previous dose of SPIKEVAX (COVID-19 Vaccine, mRNA) or Moderna COVID-19 Vaccine

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had a severe allergic reaction to any ingredient in these vaccines

WHAT ARE THE INGREDIENTS IN THESE VACCINES?

SPIKEVAX (COVID-19 Vaccine, mRNA), Moderna COVID-19 Vaccine, and Moderna COVID-19 Vaccine, Bivalent 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 ARE THESE VACCINES GIVEN?

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

Primary Series: SPIKEVAX (COVID-19 Vaccine, mRNA) and Moderna COVID-19 Vaccine are 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: Moderna COVID-19 Vaccine, Bivalent is administered as a single booster dose at least 2 months after:

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completion of primary vaccination with any authorized or approved COVID-19 vaccine; or

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receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

HAVE THESE VACCINES BEEN USED BEFORE?

Millions of individuals 18 years of age and older have received the Moderna COVID-19 Vaccine under EUA since December 18, 2020. In clinical trials, approximately 30,000 individuals 12 years of age and older, 4,000 individuals 6 years through 11 years of age, and 5,000 individuals 6 months through 5 years of age have received at least 1 dose of Moderna COVID-19 Vaccine.

In a clinical trial, approximately 400 individuals 18 years of age and older received 1 dose of a bivalent vaccine that differs from the Moderna COVID-19 Vaccine, Bivalent in that it contains a different Omicron component.

WHAT ARE THE BENEFITS OF THESE VACCINES?

SPIKEVAX (COVID-19 Vaccine, mRNA) and Moderna COVID-19 Vaccine have been shown to prevent COVID-19. FDA has authorized Moderna COVID-19 Vaccine, Bivalent to provide better protection against COVID-19 caused by the Omicron variant of SARS-CoV-2.

The duration of protection against COVID-19 is currently unknown.

WHAT ARE THE RISKS OF THESE VACCINES?

There is a remote chance that these vaccines could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose. For this reason, the vaccination provider may ask you or your child to stay at the place where you or your child received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

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Difficulty breathing

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Swelling of your face and throat

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A fast heartbeat

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A bad rash all over your body

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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 (COVID-19 Vaccine, mRNA) or Moderna COVID-19 Vaccine, more commonly in adult 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 or your child have any of the following symptoms after receiving the vaccine:

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Chest pain

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Shortness of breath

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

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

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

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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 include:

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Severe allergic reactions

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Urticaria (itchy rash/hives)

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Myocarditis (inflammation of the heart muscle)

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Pericarditis (inflammation of the lining outside the heart)

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Fainting in association with injection of the vaccine

These may not be all the possible side effects of these vaccines. Serious and unexpected side effects may occur. The possible side effects of these vaccines are still being studied.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?

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

Call the vaccination provider or your or your child’s healthcare provider if you or your child 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)”, “Moderna COVID-19 Vaccine EUA,” or “Moderna COVID-19 Vaccine, Bivalent 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 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 OR NOT TO HAVE MY CHILD GET SPIKEVAX (COVID-19 VACCINE, mRNA), MODERNA COVID-19 VACCINE, OR MODERNA COVID-19 VACCINE, BIVALENT?

Under the EUA, there is an option to accept or refuse receiving the vaccine. Should you decide not to receive, or for your child not to receive, any of these vaccines, it will not change the standard medical care.

ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES SPIKEVAX (COVID-19 VACCINE, mRNA), MODERNA COVID-19 VACCINE, OR MODERNA COVID-19 VACCINE, BIVALENT?

For primary vaccination in individuals 12 years of age and older, another choice for preventing COVID-19 is COMIRNATY (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. For individuals 6 years of age and older, other vaccines to prevent COVID-19 may be available under EUA, including bivalent vaccines that contain an Omicron component of SARS-CoV-2.

CAN I OR MY CHILD RECEIVE SPIKEVAX (COVID-19 VACCINE, mRNA), MODERNA COVID-19 VACCINE, OR MODERNA COVID-19 VACCINE, BIVALENT AT THE SAME TIME AS OTHER VACCINES?

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

WHAT IF I AM, OR MY CHILD IS, IMMUNOCOMPROMISED?

If you are, or your child is, immunocompromised, you or your child may receive a third primary series dose of Moderna COVID-19 Vaccine or SPIKEVAX (COVID-19 Vaccine, mRNA). Individuals 6 years of age and older may receive a booster dose with Moderna COVID-19 Vaccine, Bivalent. Vaccinations may not provide full immunity to COVID-19 in people who are immunocompromised; therefore, you or your child should continue to maintain physical precautions to help prevent COVID-19. Your close contacts should be vaccinated as appropriate.

WHAT ABOUT PREGNANCY OR BREASTFEEDING?

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

WILL THESE VACCINES GIVE ME OR MY CHILD COVID-19?

No. These vaccines do not contain SARS-CoV-2 and cannot give you or your child COVID-19.

KEEP THE VACCINATION CARD

When you, or your child, receive the first COVID-19 vaccine, you will get a vaccination card. Remember to bring the card when you return.

ADDITIONAL INFORMATION

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.

Moderna COVID-19 Vaccine website	Telephone number
www.modernatx.com/covid19vaccine-eua	1-866-MODERNA (1-866-663-3762)

HOW CAN I LEARN MORE?

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Ask the vaccination provider

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Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html

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Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

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Contact your state or local public health department

WHERE WILL VACCINATION INFORMATION BE RECORDED?

The vaccination provider may include your or your child’s vaccination information in your state/local jurisdiction’s Immunization Information System (IIS) or other designated system. 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 THESE COVID-19 VACCINES?

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 these vaccines. 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)?

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: Dec/8/2022

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13

 You may receive this Fact Sheet even if your child is 5 years old. Children who will turn from 5 years to 6 years of age between doses in the primary series may receive, for any dose, either: (1) the Moderna COVID-19 Vaccine authorized for use in individuals 6 months through 5 years of age; or (2) Moderna COVID-19 Vaccine authorized for use in individuals 6 years through 11 years of age.
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).

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 FDA-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 without presenting any safety or effectiveness concerns.

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Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.

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 FDA-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 without presenting any safety or effectiveness concerns.

Package/Label Display Panel

NDC 80777-273-10

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

5.5 mL Multi-Dose Vial

Primary dose: 0.5 mL

Booster dose: 0.25 mL

Maximum punctures per vial: 20

Package/Label Display Panel

NDC 80777-273-99

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

STORE FROZEN between -50° to -15°C (-58° to 5°F).

Protect from light

Ten multi-dose vials containing 5.5 mL

Primary Series Dose: Each 0.5 mL

Booster Dose: 0.25 mL

Maximum punctures per vial: 20

Package/Label Display Panel

NDC 80777-273-15

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

7.5 mL Multi-Dose Vial

Primary dose: 0.5 mL

Booster dose: 0.25 mL

Maximum punctures per vial: 20

Package/Label Display Panel

NDC 80777-273-98

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

STORE FROZEN between -50° to -15°C (-58° to 5°F).

Protect from light

Ten multi-dose vials containing 7.5 mL

Primary Series Dose: Each 0.5 mL

Booster Dose: 0.25 mL

Maximum punctures per vial: 20