Vaccine Information: Moderna COVID-19 Vaccine (Page 2 of 6)

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 “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.
  • The recipient or their caregiver has the 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 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, visit: www.cdc.gov/vsafe.

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

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 18 years 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 “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):
    1. vaccine administration errors whether or not associated with an adverse event,
    2. serious adverse events* (irrespective of attribution to vaccination),
    3. cases of Multisystem Inflammatory Syndrome (MIS) in adults, and
    4. cases of COVID-19 that result in hospitalization or death.
  5. 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.
  6. The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults, 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:
    1. Death;
    2. A life-threatening adverse event;
    3. Inpatient hospitalization or prolongation of existing hospitalization;
    4. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
    5. A congenital anomaly/birth defect;
    6. 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.

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

Moderna QR code

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

AVAILABLE ALTERNATIVES

Comirnaty (COVID-19 Vaccine, mRNA) is an FDA-approved vaccine 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, for active immunization to prevent COVID-19 in individuals 18 years of age and older.

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

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 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 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

©2021 ModernaTX, Inc. All rights reserved.
Patent(s): www.modernatx.com/patents
Revised: Aug/27/2021

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*

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

1 AUTHORIZED USE

10 DRUG INTERACTIONS

2 DOSAGE AND ADMINISTRATION

11 USE IN SPECIFIC POPULATIONS

2.1 Preparation for Administration

11.1 Pregnancy

2.2 Administration

11.2 Lactation

2.3 Dosing and Schedule

11.3 Pediatric Use

3 DOSAGE FORMS AND STRENGTHS

11.4 Geriatric Use

4 CONTRAINDICATIONS

11.5 Use in Immunocompromised

5 WARNINGS AND PRECAUTIONS

13 DESCRIPTION

5.1 Management of Acute Allergic Reactions

14 CLINICAL PHARMACOLOGY

5.2 Myocarditis and Pericarditis

14.1 Mechanism of Action

5.3 Syncope

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

5.4 Altered Immunocompetence

19 HOW SUPPLIED/STORAGE AND HANDLING

5.5 Limitations of Vaccine Effectiveness

20 PATIENT COUNSELING INFORMATION

6 OVERALL SAFETY SUMMARY

21 CONTACT INFORMATION

6.1 Clinical Trials Experience

*Sections or subsections omitted from the full prescribing information are not listed

6.2 Post-Authorization Experience

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