Assessment File

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING
VACCINE (VACCINATION PROVIDERS)

EMERGENCY USE AUTHORIZATION (EUA) OF
THE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019
(COVID-19)
PRIMARY SERIES PRESENTATION

6 months through 5 years of age
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 dark blue cap and a label with a magenta border which is authorized for use to
provide a two-dose primary series to individuals 6 months through 5 years of age. The
vaccine is also authorized to provide a third primary series dose to individuals 6 months
through 5 years of age who have been determined to have certain kinds of
immunocompromise.1
Moderna COVID-19 Vaccine supplied in multiple-dose vials with a dark blue cap and a
label with a magenta border intended for use in individuals 6 months through 5 years of
age should not be used in individuals 6 years of age and older because of the potential for
vaccine administration errors, including dosing errors.2,3
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
Notwithstanding the age limitations for use of the different presentations of the Moderna COVID-19 Vaccine,
individuals who will turn from 5 years to 6 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 months
through 5 years of age (each 0.25 mL dose containing 25 mcg mRNA) supplied in multiple-dose vials with dark
blue caps and labels with a magenta border; (2) 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”; 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.
3
For primary vaccination of individuals 6 years through 11 years of age and 12 years of age and older, refer to the
respective Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine.
Revised: Aug/31/2022 1
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.
The Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a
label with a magenta border is administered as a primary series of two doses (0.25 mL each) 1
month apart to individuals 6 months through 5 years of age.
A third primary series dose (0.25 mL) of the Moderna COVID-19 Vaccine supplied in a multiple
dose vial with a dark blue cap and a label with a magenta border is authorized for administration
at least 1 month following the second dose to individuals 6 months through 5 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.
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
Storage and Handling

The information in this Fact Sheet supersedes the information on the vial and carton labels.
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.
o Vials may be stored between 8°C to 25°C (46°F to 77°F) for a total of 24 hours.
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.
Dosing and Schedule
A third primary series dose (0.25 mL) of the Moderna COVID-19 Vaccine supplied in a
multiple-dose vial with a dark blue cap and a label with a magenta border is authorized for
administration at least 1 month following the second dose to individuals 6 months through 5
years of age with certain kinds of immunocompromise.
Preparation for Administration

• The Moderna COVID-19 Vaccine multiple-dose vial with a dark blue cap and a label
with a magenta border is supplied as a frozen suspension that does not contain a
preservative and must be thawed prior to administration.
• Verify that the vial of Moderna COVID-19 Vaccine has a dark blue cap and a label with
a magenta border.
• Thaw each vial before use following the instructions below.
Thawing Instructions for Moderna COVID-19 Vaccine Multiple-Dose Vials with
Dark Blue Caps and Labels with a Magenta Border
Thaw in Refrigerator Thaw at Room Temperature

Thaw between 2°C to 8°C (36°F to 46°F) Alternatively, thaw between 15°C to
for 2 hours. Let each vial stand at room 25°C (59°F to 77°F) for 45 minutes.
temperature for 15 minutes before
administering.
• After thawing, do not refreeze.

• Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not
dilute the vaccine.
• Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container permit.
• The Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain
white or translucent product-related particulates. Do not administer if vaccine is
discolored or contains other particulate matter.
• Each multiple-dose vial with a dark blue cap and a label with a magenta border contains
10 primary series doses of 0.25 mL each; low dead-volume syringes and/or needles can
be used to extract 10 doses from a single vial. If standard syringes and needles are used,
there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of
the type of syringe and needle:
o Each dose must contain 0.25 mL of vaccine;
o If the amount of vaccine remaining in the vial cannot provide a full dose of 0.25
mL, discard the vial and content;
o Do not pool excess vaccine from multiple vials.
• After the first 0.25 mL dose has been withdrawn, the vial should be held between 2°C to
25°C (36°F to 77°F). Record the date and time of first use on the Moderna COVID-19
Vaccine vial label. Discard vial after 12 hours. Do not refreeze.
Administration
Administer the Moderna COVID-19 Vaccine intramuscularly.
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 demonstrate increased risks of myocarditis and pericarditis, particularly
within 7 days following the second dose. 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. 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 in individuals 6 months through 23 months of age following administration of
the primary series included irritability/crying, pain at the injection site, sleepiness, loss of
appetite, fever, swelling at the injection site, erythema at the injection site, and axillary (or groin)
swelling/tenderness. (See Full EUA Prescribing Information)
Adverse reactions in individuals 24 months through 36 months of age following administration

of the primary series included pain at the injection site, irritability/crying, sleepiness, loss of
appetite, fever, erythema at the injection site, swelling at the injection site, and axillary (or groin)
swelling/tenderness. (See Full EUA Prescribing Information)
Adverse reactions in individuals 37 months through 5 years of age following administration of

the primary series included pain at the injection site, fatigue, headache, myalgia, fever, chills,
nausea/vomiting, axillary (or groin) swelling/tenderness, arthralgia, erythema at the injection
site, and swelling at the injection site. (See Full EUA Prescribing Information)
Adverse Reactions in Post-Authorization Experience

Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been
reported following administration of the Moderna COVID-19 Vaccine outside of clinical trials.
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 “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 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 AUTHORIZATION4
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):
4
Vaccination providers administering SPIKEVAX (COVID-19 Vaccine, mRNA) must adhere to the same reporting
requirements.
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 “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.
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
[email protected] 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
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.
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 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
[email protected], 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: Aug/31/2022
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* 10 DRUG INTERACTIONS

1 AUTHORIZED USE 11 USE IN SPECIFIC POPULATIONS
2 DOSAGE AND ADMINISTRATION 11.3 Pediatric Use
2.1 Preparation for Administration 11.4 Use in Immunocompromised Individuals
2.2 Administration 13 DESCRIPTION
2.3 Dosing and Schedule 14 CLINICAL PHARMACOLOGY
3 DOSAGE FORMS AND STRENGTHS 14.1 Mechanism of Action
4 CONTRAINDICATIONS 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA
5 WARNINGS AND PRECAUTIONS FOR EUA
5.1 Management of Acute Allergic Reactions 18.1 Efficacy of Two-Dose Primary Series in Participants 18 Years
5.2 Myocarditis and Pericarditis and Older
5.3 Syncope 18.2 Effectiveness of Two-Dose Primary Series in Individuals 6
5.4 Altered Immunocompetence Months Through 5 Years of Age
5.5 Limitations of Vaccine Effectiveness 18.3 Immunogenicity in Solid Organ Transplant Recipients
6 OVERALL SAFETY SUMMARY 19 HOW SUPPLIED/STORAGE AND HANDLING
6.1 Clinical Trials Experience 20 PATIENT COUNSELING INFORMATION
6.2 Post-Authorization Experience 21 CONTACT INFORMATION
8 REQUIREMENTS AND INSTRUCTIONS FOR *Sections or subsections omitted from the full prescribing
REPORTING ADVERSE EVENTS AND VACCINE information are not listed
ADMINISTRATION ERRORS
______________________________________________________________________________
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 dark blue cap and a label with a magenta border, which is authorized
for use in individuals 6 months through 5 years of age.
2 DOSAGE AND ADMINISTRATION
For intramuscular injection only.
The storage, preparation, and administration information in this EUA Prescribing Information
apply to the Moderna COVID-19 Vaccine for individuals 6 months through 5 years of age,
which is supplied in a multiple-dose vial with a dark blue cap and a label with a magenta border.
2.1 Preparation for Administration
• The Moderna COVID-19 Vaccine multiple-dose vial with a dark blue cap and a label
with a magenta border is supplied as a frozen suspension that does not contain a
preservative and must be thawed prior to administration.
• Verify that the vial of Moderna COVID-19 Vaccine has a dark blue cap and a label with
a magenta border.
• Thaw each vial before use following the instructions below.
Thawing Instructions for Moderna COVID-19 Vaccine Multiple-Dose Vials with

Dark Blue Caps and Labels with a Magenta Border
Thaw in Refrigerator Thaw at Room Temperature

Thaw between 2°C to 8°C (36°F to 46°F) Alternatively, thaw between 15°C to
for 2 hours. Let each vial stand at room 25°C (59°F to 77°F) for 45 minutes.
temperature for 15 minutes before
administering.
• After thawing, do not refreeze.

• Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not
dilute the vaccine.
• Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container permit.
• The Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain
white or translucent product-related particulates. Do not administer if vaccine is
discolored or contains other particulate matter.
• Each multiple-dose vial with a dark blue cap and a label with a magenta border contains
10 primary series doses of 0.25 mL each;. low dead-volume syringes and/or needles can
be used to extract 10 doses from a single vial. If standard syringes and needles are used,
there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of
the type of syringe and needle:
o Each dose must contain 0.25 mL of vaccine;
o If the amount of vaccine remaining in the vial cannot provide a full dose of 0.25
mL, discard the vial and content;
o Do not pool excess vaccine from multiple vials.
• After the first 0.25 mL dose has been withdrawn, the vial should be held between 2°C to
25°C (36°F to 77°F). Record the date and time of first use on the Moderna COVID-19
Vaccine vial label. Discard vial after 12 hours. Do not refreeze.
2.2 Administration
Administer the Moderna COVID-19 Vaccine intramuscularly.
2.3 Dosing and Schedule
A third primary series dose (0.25 mL) of the Moderna COVID-19 Vaccine supplied in a
multiple-dose vial with a dark blue cap and a label with a magenta border is authorized for
administration at least 1 month following the second dose to individuals 6 months through 5
years of age with certain kinds of immunocompromise.
3 DOSAGE FORMS AND STRENGTHS
Moderna COVID-19 Vaccine is a suspension for injection. Each dose of the Moderna COVID-
19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a magenta
border for individuals 6 months through 5 years of age is 0.25 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
5.1 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).
5.2 Myocarditis and Pericarditis
Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly

within 7 days following the second dose. 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. 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).
5.3 Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines.
Procedures should be in place to avoid injury from fainting.
5.4 Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressive therapy, may

have a diminished response to the Moderna COVID-19 Vaccine.
5.5 Limitations of Vaccine Effectiveness
The Moderna COVID-19 Vaccine may not protect all vaccine recipients.
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.5 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.
In a clinical study, the adverse reactions in participants 6 months through 23 months of age
following administration of the primary series were irritability/crying (81.5%), pain at the
injection site (56.2%), sleepiness (51.1%), loss of appetite (45.7%), fever (21.8%), swelling at
the injection site (18.4%), erythema at the injection site (17.9%), and axillary (or groin)
swelling/tenderness (12.2%).
In a clinical study, the adverse reactions in participants 24 months through 36 months of age
following administration of the primary series were pain at the injection site (76.8%),
irritability/crying (71.0%), sleepiness (49.7%), loss of appetite (42.4%), fever (26.1%), erythema
at the injection site (17.9%), swelling at the injection site (15.7%), and axillary (or groin)
swelling/tenderness (11.5%).
In a clinical study, the adverse reactions in participants 37 months through 5 years of age
following administration of the primary series were pain at the injection site (83.8%), fatigue
(61.9%), headache (22.9%), myalgia (22.1%), fever (20.9%), chills (16.8%), nausea/vomiting
(15.2%), axillary (or groin) swelling/tenderness (14.3%), arthralgia (12.8%), erythema at the
injection site (9.5%), and swelling at the injection site (8.2%).
5
requirements.
Post-Authorization Experience
Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been
reported following administration of the Moderna COVID-19 Vaccine outside of clinical trials.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical
trials of another vaccine and may not reflect the rates observed in practice.
Overall, approximately 39,000 participants aged 6 months and older received at least one dose of
Moderna COVID-19 Vaccine in five clinical trials (NCT04283461, NCT04405076,
NCT04470427, NCT04649151, and NCT04796896). In a sixth clinical trial (NCT04885907), 60
solid organ transplant recipients received a third dose of Moderna COVID-19 Vaccine.
Study 1 (NCT04470427) is a Phase 3 randomized, placebo-controlled, observer-blind clinical

trial conducted in the United States involving 30,346 participants 18 years of age and older who
received at least one dose of Moderna COVID-19 Vaccine6 (n=15,184) or placebo (n=15,162).
Study 3 (NCT04649151) is a Phase 2/3 randomized, placebo-controlled, observer-blind, clinical
trial conducted in the United States involving 3,726 participants 12 years through 17 years of age
who received at least one dose of Moderna COVID-19 Vaccine (n=2,486) or placebo (n=1,240).
Study 4 (NCT04796896) includes an ongoing Phase 2/3 randomized, placebo-controlled,
observer-blind clinical trial component conducted in the United States and Canada involving
10,390 participants 6 months through 11 years of age who received at least one dose of Moderna
COVID-19 Vaccine (n=7,799) or placebo (n=2,591).
Individuals 6 Months Through 5 Years of Age
Safety data for Moderna COVID-19 Vaccine from the ongoing Phase 2/3 randomized, placebo-
controlled, observer-blind clinical trial conducted in the United States and Canada included data
in 6,388 participants 6 months through 5 years of age who received at least one dose of Moderna
COVID-19 Vaccine (n=4,792) or placebo (n=1,596) (Study 4). As of the data cutoff date of
February 21, 2022, the median duration of blinded follow-up for safety for participants 6 months
through 23 months was 68 days after Dose 2. For participants 2 years to 5 years, the median
duration of blinded follow-up for safety was 71 days after Dose 2.
For participants 6 months through 23 months, 51.1% were male, 48.9% were female, 13.2%
were Hispanic or Latino, 79.0% were White, 3.1% were African American, 4.9% were Asian,
0.2% were American Indian or Alaska Native, 0.0% were Native Hawaiian or Pacific Islander,
1.5% were other races, and 10.6% were Multiracial. For participants 2 years through 5 years,
50.8% were male, 49.2% were female, 14.2% were Hispanic or Latino, 76.5% were White, 4.5%
were African American, 6.0% were Asian, 0.4% were American Indian or Alaska Native, 0.3%
6
Moderna COVID-19 Vaccine is marketed as SPIKEVAX (COVID-19 Vaccine, mRNA), which is approved for
use in individuals 18 years of age and older.
were Native Hawaiian or Pacific Islander, 1.5% were other races, and 10.4% were Multiracial.
Demographic characteristics were similar among participants who received Moderna COVID-19
Vaccine and those who received placebo.
Solicited Adverse Reactions
Local and systemic adverse reactions and use of antipyretic medication were solicited in an
electronic diary for 7 days following each injection (i.e., day of vaccination and the next 6 days)
among participants receiving Moderna COVID-19 Vaccine and participants receiving placebo
with at least 1 documented dose (for participants 6 through 23 months, vaccine=1,758,
placebo=585; for participants 24 months to 36 months, vaccine=986, placebo=338; for
participants 37 months to 5 years, vaccine=2,030, placebo=659). Events that persisted for more
than 7 days were followed until resolution.
The reported number and percentage of the solicited local and systemic adverse reactions by
dose in Study 4 participants 6 months through 23 months of age are presented in Table 1,
participants 24 months through 36 months of age are presented in Table 2, and participants 37
months to 5 years are presented in Table 3.
Table 1: Number and Percentage of Participants With Solicited Local and Systemic
Adverse Reactions Starting Within 7 Days* After Each Dose in Participants 6 Months
Through 23 Months (Solicited Safety Set, Dose 1 and Dose 2)†
Moderna COVID-19 Vaccine Placeboa
Dose 1 Dose 2 Dose 1 Dose 2

(N= 1,746) (N=1,596) (N= 582) (N=526)
n (%) n (%) n (%) n (%)
Local Adverse
Reactions
Pain 652 738 175 135
(37.4) (46.2) (30.1) (25.7)
Axillary (or groin) 102 148 26 28
swelling/tenderness (5.9) (9.3) (4.5) (5.3)
Erythema (redness) 150 216 24 20
≥5 mm (8.6) (13.5) (4.1) (3.8)
Grade 3: >50 mm (0.3) (0.9) (0.3) (0)
Swelling (hardness) 146 244 15 11
≥5 mm (8.4) (15.3) (2.6) (2.1)
Grade 3: >50 mm (0.3) (0.9) (0) (0)
Systemic Adverse
Reactions
Irritability/crying 1,175 1,021 361 307
(67.6) (64.3) (62.1) (58.5)
Irritability/crying, 24 25 6 5
Grade 3b (1.4) (1.6) (1.0) (1.0)

(N= 1,746) (N=1,596) (N= 582) (N=526)
n (%) n (%) n (%) n (%)
Sleepiness 645 558 217 175
(37.1) (35.1) (37.3) (33.3)
Sleepiness, Grade 3c 4 1 1 1
(0.2) (<0.1) (0.2) (0.2)
Loss of appetite 524 510 152 132
(30.2) (32.1) (26.2) (25.1)
Loss of appetite, 10 16 1 2
Grade 3d (0.6) (1.0) (0.2) (0.4)
Fever 191 232 49 44
>38.0°C / >100.4°F (11.0) (14.6) (8.4) (8.4)
Fever, 11 7 3 6
Grade 3: 39.6° - 40.0°C / (0.6) (0.4) (0.5) (1.1)
101.1° - 104.0°F
Fever, 1 3 1 0
Grade 4: >40.0°C / (<0.1) (0.2) (0.2) (0)
>104.0°F
Use of antipyretic or 482 543 141 111
pain medication (27.6) (34.0) (24.2) (21.1)
N = Included 16 individuals aged 2 years to 4 years randomized in the 6 months through 23 months of age group
stratum (13 in the Moderna COVID-19 Vaccine group and 3 in the placebo group).
* 7 days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication
were collected in the electronic diary (e-diary).
† Absence of rows for Grade 3 or Grade 4 adverse reactions indicates no events were reported.
a
Placebo was a saline solution.
b
Grade 3 irritability/crying: Defined as lasting >3 hours or inconsolable.
c
Grade 3 sleepiness: Defined as sleeps most of the time, hard to arouse.
d
Grade 3 loss of appetite: Defined as missed >2 feeds/meals completely or refuses most feeds/meals.
Table 2: Number and Percentage of Participants With Solicited Local and System Adverse
Reactions Starting Within 7 Days* After Each Dose in Participants 24 Months Through 36
Months (Solicited Safety Set, Dose 1 and Dose 2)†

(N=944) (N=963) (N=320) (N=330)
n (%) n (%) n (%) n (%)
Local Adverse
Reactions
Pain 500 654 119 146
(53.1) (67.9) (37.2) (44.2)
Pain, Grade 3b 3 5 0 0
(0.3) (0.5) (0) (0)
swelling/tenderness, (0) (0.1) (0) (0)
Grade 3b

(N=944) (N=963) (N=320) (N=330)
n (%) n (%) n (%) n (%)
≥5 mm (10.0) (12.1) (4.1) (3.0)
Erythema (redness), 6 9 2 0
Grade 3: >50 mm (0.6) (0.9) (0.6) (0)
≥5 mm (8.2) (11.5) (3.4) (2.1)
Swelling (hardness), 5 8 2 0
Grade 3: >50 mm (0.5) (0.8) (0.6) (0)
Systemic Adverse
Reactions
Irritability/crying 513 523 163 148
(54.5) (54.3) (51.1) (44.8)
Irritability/crying, 12 10 6 2
Grade 3c (1.3) (1.0) (1.9) (0.6)
Sleepiness 285 347 92 89
(30.3) (36.0) (28.8) (27.0)
Sleepiness, Grade 3d 2 1 0 0
(0.2) (0.1) (0) (0)
Loss of appetite 225 294 71 69
(23.9) (30.5) (22.3) (20.9)
Loss of appetite, 7 8 1 0
Grade 3e (0.7) (0.8) (0.3) (0)
Fever 106 182 25 35
≥38.0°C / >100.4°F (11.3) (18.9) (7.8) (10.6)
Fever, 3 12 3 0
Grade 3: 39.6° - 40.0°C / (0.3) (1.2) (0.9) (0)
103.2° - 104.0°F
Fever, 3 3 1 0
Grade 4: >40.0°C / (0.3) (0.3) (0.3) (0)
>104.0°F
pain medication (20.4) (30.3) (18.4) (18.8)
N = Included 36 individuals younger than 2 years of age randomized in the 2 years through 5 years of age group
stratum (24 in the Moderna COVID-19 Vaccine group and 12 in the placebo group). All of these 36 individuals
had eDiary for 6 months to ≤36 months age group.
a
b
Grade 3 pain, axillary swelling/tenderness: Defined as prevents daily activity.
c
Grade 3 irritability/crying: Defined as lasting >3 hours or inconsolable.
d
Grade 3 sleepiness: Defined as sleeps most of the time, hard to arouse.
e
Grade 3 loss of appetite: Defined as missed >2 feeds/meals completely or refuses most feeds/meals.
Table 3: Number and Percentage of Participants With Solicited Local and System Adverse
Reactions Starting Within 7 Days* After Each Dose in Participants 37 Months Through 5
Years (Solicited Safety Set, Dose 1 and Dose 2)†

(N=2,013) (N= 1,975) (N=650) (N= 629)
n (%) n (%) n (%) n (%)
Local Adverse
Reactions
Pain 1,313 1,445 263 249
(65.2) (73.2) (40.5) (39.6)
Pain, Grade 3b 1 6 0 0
(<0.1) (0.3) (0) (0)
≥25 mm (3.5) (7.2) (0.2) (0.8)
Erythema (redness), 6 3 1 0
Grade 3: >100 mm (0.3) (0.2) (0.2) (0)
≥25 mm (2.8) (6.5) (0.9) (0.6)
Swelling (hardness), 5 5 0 0
Grade 3: >100 mm (0.2) (0.3) (0) (0)
Systemic Adverse
Reactions
Fatigue 807 956 236 185
(40.1) (48.4) (36.3) (29.4)
Fatigue, Grade 3c 21 45 11 8
(1.0) (2.3) (1.7) (1.3)
Headache 232 310 78 51
(11.5) (15.7) (12.0) (8.1)
Headache, Grade 3c 5 8 2 1
(0.2) (0.4) (0.3) (0.2)
Fever 155 316 33 28
≥38.0°C / >100.4°F (7.7) (16.0) (5.1) (4.5)
Fever, 23 58 4 2
Grade 3: 39.0° - 40.0°C / (1.1) (2.9) (0.6) (0.3)
102.1° - 104.0°F
Fever, 0 2 1 0
Grade 4: >40.0°C / (0) (0.1) (0.2) (0)
>104.0°F
Myalgia 200 310 60 47
(9.9) (15.7) (9.2) (7.5)
Myalgia, Grade 3c 5 9 2 3
(0.2) (0.5) (0.3) (0.5)
Chills 129 245 40 31
(6.4) (12.4) (6.2) (4.9)
Chills, Grade 3c 1 4 0 2
(<0.1) (0.2) (0) (0.3)
Nausea/vomiting 137 194 50 30
(6.8) (9.8) (7.7) (4.8)

(N=2,013) (N= 1,975) (N=650) (N= 629)
n (%) n (%) n (%) n (%)
Nausea/vomiting, 7 6 2 0
Grade 3c (0.3) (0.3) (0.3) (0)
Arthralgia 124 168 32 28
(6.2) (8.5) (4.9) (4.5)
Arthralgia, Grade 3c 2 3 1 0
(<0.1) (0.2) (0.2) (0)
pain medication (15.2) (25.7) (9.5) (6.8)
a
b
Grade 3 pain: Defined as prevents daily activity.
c
Grade 3 fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting: Defined as prevents daily activity.
Solicited local and systemic adverse reactions reported following administration of Moderna
COVID-19 Vaccine had a median duration of 2 to 3 days for participants 6 through 23 months
years of age and 2 days for participants 2 through 5 years of age.
An assessment of reactogenicity among participants with evidence of prior SARS-CoV-2

infection (immunologic or virologic evidence of prior SARS-CoV-2 infection [defined as
positive RT-PCR test and/or positive Elecsys immunoassay result at Day 1]) compared to those
with no evidence of infection at baseline (negative RT-PCR test and negative Elecsys
immunoassay result at Day 1) was conducted. In the 6 months through 23 months of age cohort,
6.1% of participants (vaccine=106, placebo=38) had evidence of prior SARS-CoV-2 infection at
baseline. In the 2 years through 5 years of age cohort, 8.6% of participants (vaccine=266,
placebo=82) had evidence of prior SARS-CoV-2 infection at baseline. In each age cohort, fever
(temperature >38°C) was reported in a greater proportion of baseline SARS-CoV-2 positive
vaccine participants compared to baseline SARS-CoV-2 negative vaccine participants. There
were no notable differences in other reactogenicity events.
Unsolicited Adverse Events
Participants were monitored for unsolicited adverse events for up to 28 days following each dose
and follow-up is ongoing. Serious adverse events and medically attended adverse events will be
recorded for the entire study duration.
As of February 21, 2022, among participants 6 months through 23 months of age who had
received at least 1 dose of vaccine or placebo (vaccine=1,761, placebo=589), unsolicited adverse
events that occurred within 28 days following each vaccination were reported by 49.3% of
participants (n=869) who received Moderna COVID-19 Vaccine and 48.2% of participants
(n=284) who received placebo. In these analyses, 83.1% of study participants 6 months through
23 months of age had at least 28 days of follow-up after Dose 2. Among participants 2 years
through 5 years of age who had received at least 1 dose of vaccine or placebo (vaccine=3,031,
placebo=1,007), unsolicited adverse events that occurred within 28 days following each
vaccination were reported by 40.0% of participants (n=1,212) who received Moderna COVID-19
Vaccine and 37.5% of participants (n=378) who received placebo. In these analyses, 89.3% of
study participants 2 years through 5 years of age had at least 28 days of follow-up after Dose 2.
During the 28-day follow-up period following any dose, lymphadenopathy-related events were
reported by 1.5% of vaccine recipients and 0.2% of placebo recipients who were 6 months
through 23 months of age and 0.9% of vaccine recipients and <0.1% of placebo recipients who
were 2 years through 5 years of age. These events included lymphadenopathy, injection-site
lymphadenopathy, and vaccination-site lymphadenopathy which were plausibly related to
vaccination. This imbalance is consistent with the imbalance observed for solicited axillary (or
groin) swelling/tenderness in the injected limb.
During the 28-day follow-up period following any dose, hypersensitivity adverse events were
reported in 3.9% of vaccine recipients and 5.3% of placebo recipients who were 6 months
through 23 months of age and 3.5% of vaccine recipients and 2.5% of placebo recipients who
were 2 years through 5 years of age. Hypersensitivity events in the vaccine group included
injection site rash and injection site urticaria, which are likely related to vaccination. Delayed
injection site reactions that began >7 days after vaccination were reported in 1.2% of vaccine
recipients and no placebo recipients who were 6 months through 23 months of age and 1.4% of
vaccine recipients and <0.1% of placebo recipients who were 2 years through 5 years of age.
Delayed injection site reactions included pain, erythema, and swelling and are likely related to
vaccination.
During the 28-day follow-up period following any dose, events of abdominal pain (including
abdominal pain, abdominal pain upper, and abdominal discomfort) were reported by 0.7% of
vaccine recipients and 0.4% of placebo recipients who were 2 years through 5 years of age.
Currently available information is insufficient to determine a causal relationship with the
vaccine.
There were no other notable patterns or numerical imbalances between treatment groups for
specific categories of adverse events that would suggest a causal relationship to Moderna
COVID-19 Vaccine.
Serious Adverse Events
As of February 21, 2022, serious adverse events were reported by 0.9% (n=15) of participants
who received vaccine and 0.2% (n=1) of participants who received placebo who were 6 months
through 23 months of age and 0.3% (n=9) of participants who received Moderna COVID-19
Vaccine and 0.2% (n=2) of participants who received placebo who were 2 years through 5 years
of age. In these analyses, 83.1% of study participants 6 months through 23 months of age had at
least 28 days of follow-up after Dose 2, and the median follow-up time for all participants was
68 days after Dose 2. In these analyses, 89.3% of study participants 2 years through 5 years of
age had at least 28 days of follow-up after Dose 2, and the median follow-up time for all
participants was 71 days after Dose 2.
In participants 6 months through 23 months of age who received the vaccine, a 1-year-old female
experienced serious adverse events of a Grade 3 fever 6 hours after Dose 1 and a febrile
convulsion 1 day after Dose 1. These events were considered related to vaccination. In
participants 2 years through 5 years of age who received Moderna COVID-19 Vaccine, none of
the events were considered related to vaccine.
Individuals 6 Years Through 11 Years of Age
Safety data for Moderna COVID-19 Vaccine from Study 4 included data in 4,002 participants 6
years through 11 years of age who received at least one dose of Moderna COVID-19 Vaccine
(n=3,007) or placebo (n=995). As of the data cutoff date of November 10, 2021, the median
duration of blinded follow-up for safety was 51 days after Dose 2, and 1,284 participants had
been followed for at least 2 months after Dose 2 (vaccine=1,006, placebo=218).
Demographic characteristics in Study 4 were similar among participants who received Moderna
COVID-19 Vaccine and those who received placebo. Overall, 50.8% were male, 49.2% were
female, 18.5% were Hispanic or Latino, 65.6% were White, 10.0% were African American,
9.9% were Asian, 0.4% were American Indian or Alaska Native, <0.1% were Native Hawaiian
or Pacific Islander, 2.1% were other races, and 10.6% were Multiracial.
Participants were monitored for unsolicited adverse events for up to 28 days following each
dose. Serious adverse events and medically attended adverse events will be recorded for the
entire study duration. As of November 10, 2021, among participants who had received at least 1
dose of vaccine or placebo (vaccine=3,007, placebo=995), unsolicited adverse events that
occurred within 28 days following each vaccination were reported by 29.6% of participants
(n=891) who received Moderna COVID-19 Vaccine and 25.1% of participants (n=250) who
received placebo. In these analyses, 98.6% of study participants had at least 28 days of follow-up
after Dose 2.
reported by 1.8% of vaccine recipients and 0.6% of placebo recipients. These events included
lymphadenopathy, lymph node pain, injection-site lymphadenopathy, and vaccination-site
lymphadenopathy which were plausibly related to vaccination.
reported in 4.3% of vaccine recipients and 2.1% of placebo recipients. Hypersensitivity events in
the vaccine group included injection site rash and injection site urticaria, which are likely related
to vaccination. Delayed injection site reactions that began >7 days after vaccination were
reported in 2.7% of vaccine recipients and in 0.2% of placebo recipients. Delayed injection site
reactions included pain, erythema, and swelling and are likely related to vaccination.
During the 28-day follow-up period following any dose, events of abdominal pain (including
abdominal pain, abdominal pain upper, and abdominal pain lower) were reported by 1.1% of
vaccine recipients and 0.6% of placebo recipients. Currently available information is insufficient
to determine a causal relationship with the vaccine.
COVID-19 Vaccine.
As of November 10, 2021, serious adverse events were reported by 0.2% (n=6) of participants
who received Moderna COVID-19 Vaccine and 0.2% (n=2) participants who received placebo.
None of the events in the Moderna COVID-19 Vaccine group were considered related to
vaccine. In these analyses, 98.6% of study participants had at least 28 days of follow-up after
Dose 2, and the median follow-up time for all participants was 51 days after Dose 2.
There were no notable patterns or imbalances between treatment groups for specific categories of
serious adverse events that would suggest a causal relationship to Moderna COVID-19 Vaccine.
Additional Safety Analyses
Participants 6 years through 11 years in Study 4 started to enter an open-label, observational

phase after November 1, 2021. A long-term safety analysis was conducted in participants 6 years
through 11 years from Study 4 who received Moderna COVID-19 Vaccine (n=3,007) with a cut-
off date of February 21, 2022. In these analyses, the median duration of follow-up including both
the blinded and open-label phases was 158 days after Dose 2. Through the cut-off date, there
were no serious adverse events causally related to the vaccine.
Adolescents 12 Years Through 17 Years of Age
Safety data for Moderna COVID-19 Vaccine in adolescents were collected in an ongoing Phase
2/3 randomized, placebo-controlled, observer-blind, clinical trial conducted in the United States
involving 3,726 participants 12 years through 17 years of age who received at least one dose of
Moderna COVID-19 Vaccine (n=2,486) or placebo (n=1,240) (Study 3, NCT04649151).
Overall, 51.4% were male, 48.6% were female, 11.6% were Hispanic or Latino, 83.9% were
White, 3.4% were African American, 5.9% were Asian, 0.5% were American Indian or Alaska
Native, <0.1% were Native Hawaiian or Pacific Islander, 1.0% were other races, and 4.5% were
Multiracial. Demographic characteristics were similar among participants who received Moderna
COVID-19 Vaccine and those who received placebo.
Participants were monitored for unsolicited adverse events for up to 28 days following each
dose. Serious adverse events and medically attended adverse events will be recorded for the
entire study duration. As of May 8, 2021, among participants who had received at least 1 dose of
vaccine or placebo (vaccine=2,486, placebo=1,240), unsolicited adverse events that occurred
within 28 days following each vaccination were reported by 20.5% of participants (n=510) who
received Moderna COVID-19 Vaccine and 15.9% of participants (n=197) who received placebo.
In these analyses, 97.3% of study participants had at least 28 days of follow-up after Dose 2.
A 14-year-old male experienced probable myocarditis with onset of symptoms 1 day after Dose
2 of Moderna COVID-19 Vaccine. Symptoms resolved after 8 days and no sequelae were
observed at 5 months. There were no cases of myocarditis among placebo recipients.
During the 28-day follow-up period following any dose, lymphadenopathy-related events that
were not necessarily captured in the 7-day e-diary were reported by 5.0% of vaccine recipients
and 0.5% of placebo recipients. These events included lymphadenopathy, vaccination-site
lymphadenopathy and injection-site lymphadenopathy which were plausibly related to
vaccination.
reported in 1.8% of vaccine recipients and 0.6% of placebo recipients. Hypersensitivity events in
the vaccine group included injection site rash and injection site urticaria, which are likely related
to vaccination. Delayed injection site reactions that began >7 days after vaccination were
reported in 0.9% of vaccine recipients and in no placebo recipients. Delayed injection site
reactions included pain, erythema, and swelling and are likely related to vaccination.
COVID-19 Vaccine.
As of May 8, 2021, serious adverse events were reported by 0.2% (n=6) of participants who
received Moderna COVID-19 Vaccine and 0.2% (n=2) of participants who received placebo. In
these analyses, 97.3% of study participants had at least 28 days of follow-up after Dose 2, and
the median follow-up time for all participants was 53 days after Dose 2.
There were no notable patterns or imbalances between treatment groups for specific categories of
serious adverse events that would suggest a causal relationship to Moderna COVID-19 Vaccine.
Additional Safety Analyses
Study 3 participants started to enter an open-label, observational phase after May 10, 2021. A
long-term safety analysis was conducted in participants from Study 3 who received Moderna
COVID-19 Vaccine (n=2,486) with a cut-off date of January 31, 2022. In these analyses, the
median duration of follow-up including both the blinded and open-label phases was 312 days
after Dose 2 and 95.6% of study participants have had at least 6 months of follow-up after Dose
2. Through the cut-off date, there were no serious adverse events causally related to the vaccine.
Adults 18 Years of Age and Older
The safety of Moderna COVID-19 Vaccine was evaluated in an ongoing Phase 3 randomized,
placebo-controlled, observer-blind clinical trial conducted in the United States involving 30,346
participants 18 years of age and older who received at least one dose of Moderna COVID-19
Vaccine (n=15,184) or placebo (n=15,162) (Study 1, NCT04470427). Upon issuance of the
Emergency Use Authorization (December 18, 2020) for Moderna COVID-19 Vaccine,
participants were unblinded in a phased manner over a period of months to offer placebo
participants Moderna COVID-19 Vaccine. The median duration of follow up for safety after the
second injection during the blinded phase was 4 months. The median duration of follow up for
safety after the second injection including both the blinded phase and the open-label phase was 6
months.
In Study 1, the median age of the population was 52 years (range 18-95); 22,826 (75.2%)
participants were 18 to 64 years of age and 7,520 (24.8%) participants were 65 years of age and
older. Overall, 52.6% of the participants were male, 47.4% were female, 20.5% were Hispanic or
Latino, 79.2% were White, 10.2% were African American, 4.6% were Asian, 0.8% were
American Indian or Alaska Native, 0.2% were Native Hawaiian or Pacific Islander, 2.0% were
other races, and 2.1% were Multiracial. Demographic characteristics were similar between
participants who received Moderna COVID-19 Vaccine and those who received placebo.
Participants were monitored for unsolicited adverse events for 28 days following each dose.
Serious adverse events and medically attended adverse events will be recorded for the entire
study duration (2 years). Among the 30,346 participants who had received at least 1 dose of
vaccine (N=15,184) or placebo (N=15,162), unsolicited adverse events that occurred within 28
days following any vaccination were reported by 31.3% of participants (n=4,752) who received
Moderna COVID-19 Vaccine and 28.6% of participants (n=4,338) who received placebo.
reported by 1.7% of vaccine recipients and 0.8% of placebo recipients. These events included
lymphadenopathy, lymphadenitis, lymph node pain, vaccination-site lymphadenopathy,
injection-site lymphadenopathy, and axillary mass.
During the 7-day follow-up period of any vaccination, hypersensitivity events of injection site
rash or injection site urticaria, likely related to vaccination, were reported by 6 participants in the
Moderna COVID-19 Vaccine group and none in the placebo group. Delayed injection site
reactions that began >7 days after vaccination were reported in 1.4% of vaccine recipients and
0.7% of placebo recipients. Delayed injection site reactions included pain, erythema, and
swelling and are likely related to vaccination.
In the blinded portion of the study, there were 8 reports of facial paralysis (including Bell’s
palsy) in the Moderna COVID-19 Vaccine group, and 3 in the placebo group. In the 28-day
follow-up period there were two cases of facial paralysis in the Moderna COVID-19 Vaccine
group, which occurred on 8 and 22 days, respectively, after vaccination, and one in the placebo
group, which occurred 17 days after vaccination. Currently available information on facial
paralysis is insufficient to determine a causal relationship with the vaccine.
In the blinded portion of the study, there were 50 reports of herpes zoster in the Moderna
COVID-19 Vaccine group, and 23 in the placebo group. In the 28-day period after any
vaccination, there were 22 cases of herpes zoster in the Moderna COVID-19 Vaccine group, and
15 in the placebo group. Currently available information on herpes zoster infection is insufficient
to determine a causal relationship with the vaccine.
specific categories of adverse events (including other neurologic, neuro-inflammatory, and
thrombotic events) that would suggest a causal relationship to Moderna COVID-19 Vaccine.
During the blinded phase of the study, serious adverse events were reported by 1.8% (n=268) of
participants who received Moderna COVID-19 Vaccine and 1.9% (n=292) of participants who
received placebo.
There were three serious adverse events of angioedema/facial swelling in the vaccine group in
recipients with a history of injection of dermatological fillers. The onset of swelling was reported
1-2 days after the second dose and was likely related to vaccination.
There were no other notable patterns or imbalances between treatment groups for specific
categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic
events) that would suggest a causal relationship to Moderna COVID-19 Vaccine.
6.2 Post-Authorization Experience
The following adverse reactions have been identified during post-authorization use of the
Moderna COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always
possible to reliably estimate their frequency or establish a causal relationship to vaccine
exposure.
Cardiac Disorders: myocarditis, pericarditis

Immune System Disorders: anaphylaxis
Nervous System Disorders: syncope
8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS

AND VACCINE ADMINISTRATION ERRORS7
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
7
requirements.
• 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 [email protected].
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
[email protected] 1-866-599-1342 1-866-MODERNA

(1-866-663-3762)
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
11.3 Pediatric Use
Moderna COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of
age. This authorization is based on safety and effectiveness data in this age group and adults.
Moderna COVID-19 Vaccine is not authorized for use in individuals younger than 6 months of
age.
11.4 Use in Immunocompromised Individuals
Safety and effectiveness of the Moderna COVID-19 Vaccine in individuals 6 months through 17
years of age with immunocompromise have been extrapolated from adult data. In an independent
study (Hall VG, Ferreira VH, Ku T et al. Randomized Trial of a Third Dose of mRNA-1273
Vaccine in Transplant Recipients. N Engl J Med 2021 DOI: 10.1056/NEJMc2111462;
NCT04885907), safety and effectiveness of a third primary series dose of the Moderna COVID-
19 Vaccine have been evaluated in participants who received solid organ transplants. In this
study, in 60 adult participants who had undergone various solid organ transplant procedures
(heart, kidney, kidney-pancreas, liver, lung, pancreas) a median of 3.57 years previously (range
1.99-6.75 years) who received a third vaccine dose, the adverse event profile was similar to that
after the second dose and no Grade 3 or Grade 4 events were reported. The administration of a
third primary series vaccine dose appears to be only moderately effective in increasing antibody
titers. Patients should be counseled to maintain physical precautions to help prevent COVID-19.
In addition, close contacts of immunocompromised persons should be vaccinated, as appropriate
for their health status.
13 DESCRIPTION
Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular

injection.
Each 0.25 mL primary series dose of Moderna COVID-19 Vaccine supplied in a multiple-dose
vial with a dark blue cap and a label with a magenta border contains 25 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 0.25 mL dose of the Moderna COVID-19 Vaccine
supplied in a multiple-dose vial with a dark blue cap and a label with a magenta border contains
the following ingredients: a total lipid content of 0.5 mg (SM-102, polyethylene glycol [PEG]
2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine
[DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid,
0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose.
Moderna COVID-19 Vaccine does not contain a preservative.
The vial stoppers are not made with natural rubber latex.
14 CLINICAL PHARMACOLOGY
14.1 Mechanism of Action
The nucleoside-modified mRNA in the Moderna COVID-19 Vaccine is formulated in lipid

particles, which enable delivery of the nucleoside-modified mRNA into host cells to allow
expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S
antigen, which protects against COVID-19.
18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA
18.1 Efficacy of Two-Dose Primary Series in Participants 18 Years and Older
Study 1 is an ongoing Phase 3 randomized, placebo-controlled, observer-blind clinical trial to
evaluate the efficacy, safety, and immunogenicity of the Moderna COVID-19 Vaccine in
participants 18 years of age and older in the United States (NCT04470427). Randomization was
stratified by age and health risk: 18 to <65 years of age without comorbidities (not at risk for
progression to severe COVID-19), 18 to <65 years of age with comorbidities (at risk for
progression to severe COVID-19), and 65 years of age and older with or without comorbidities.
Participants who were immunocompromised and those with a known history of SARS-CoV-2
infection were excluded from the study. Participants with no known history of SARS-CoV-2
infection but with positive laboratory results indicative of infection at study entry were included.
The study allowed for the inclusion of participants with stable pre-existing medical conditions,
defined as disease not requiring significant change in therapy or hospitalization for worsening
disease during the 3 months before enrollment, as well as participants with stable human
immunodeficiency virus (HIV) infection. A total of 30,420 participants were randomized equally
to receive 2 doses of the Moderna COVID-19 Vaccine or saline placebo 1 month apart.
Participants will be followed for efficacy and safety until 24 months after the second dose.
The primary efficacy analysis population (referred to as the Per-Protocol Set) included 28,207
participants who received two doses (at 0 and 1 month) of either Moderna COVID-19 Vaccine
(n=14,134) or placebo (n=14,073) and had a negative baseline SARS-CoV-2 status. In the Per-
Protocol Set, 47.4% were female, 19.7% were Hispanic or Latino; 79.5% were White, 9.7% were
African American, 4.6% were Asian, and 2.1% other races. The median age of participants was
53 years (range 18-95) and 25.3% of participants were 65 years of age and older. Of the study
participants in the Per-Protocol Set, 18.5% were at increased risk of severe COVID-19 due to at
least one pre-existing medical condition (chronic lung disease, significant cardiac disease, severe
obesity, diabetes, liver disease, or HIV infection) regardless of age. Between participants who
received Moderna COVID-19 Vaccine and those who received placebo, there were no notable
differences in demographics or pre-existing medical conditions.
Efficacy Against COVID-19
COVID-19 was defined based on the following criteria: The participant must have experienced
at least two of the following systemic symptoms: fever (≥38ºC / ≥100.4°F), chills, myalgia,
headache, sore throat, new olfactory and taste disorder(s); or the participant must have
experienced at least one of the following respiratory signs/symptoms: cough, shortness of breath
or difficulty breathing, or clinical or radiographical evidence of pneumonia; and the participant
must have at least one NP swab, nasal swab, or saliva sample (or respiratory sample, if
hospitalized) positive for SARS-CoV-2 by RT-PCR. COVID-19 cases were adjudicated by a
Clinical Adjudication Committee.
The median length of follow-up for efficacy for participants in the study was 9 weeks post Dose
2. There were 11 COVID-19 cases in the Moderna COVID-19 Vaccine group and 185 cases in
the placebo group, with a vaccine efficacy of 94.1% (95% confidence interval of 89.3% to
96.8%).
Table 4: Primary Efficacy Analysis: COVID-19* in Participants 18 Years of Age and Older
Starting 14 Days After Dose 2 per Adjudication Committee Assessments – Per-Protocol Set
Moderna COVID-19 Vaccine Placebo

Participants COVID-19 Incidence Participants COVID-19 Incidence % Vaccine
(N) Cases Rate of (N) Cases Rate of Efficacy
(n) COVID-19 (n) COVID-19 (95% CI)†
per 1,000 per 1,000
Person- Person-
Years Years
14,134 11 3.328 14,073 185 56.510 94.1
(89.3, 96.8)
* COVID-19: symptomatic COVID-19 requiring positive RT-PCR result and at least two systemic symptoms or one
respiratory symptom. Cases starting 14 days after Dose 2.
† VE and 95% CI from the stratified Cox proportional hazard model.
The subgroup analyses of vaccine efficacy are presented in Table 5.
Table 5: Subgroup Analyses of Vaccine Efficacy: COVID-19* Cases Starting 14 Days After
Dose 2 per Adjudication Committee Assessments – Per-Protocol Set

Age Participants COVID-19 Incidence Participants COVID-19 Incidence %
Subgroup (N) Cases Rate of (N) Cases Rate of Vaccine
(Years) (n) COVID-19 (n) COVID-19 Efficacy
per 1,000 per 1,000 (95%
Person- Person- CI)†
Years Years
18 to <65 10,551 7 2.875 10,521 156 64.625 95.6
(90.6, 97.9)
≥65 3,583 4 4.595 3,552 29 33.728 86.4

(61.4, 95.2)
* COVID-19: symptomatic COVID-19 requiring positive RT-PCR result and at least two systemic symptoms or one
respiratory symptom. Cases starting 14 days after Dose 2.
† VE and 95% CI from the stratified Cox proportional hazard model.
Severe COVID-19 was defined based on confirmed COVID-19 as per the primary efficacy
endpoint case definition, plus any of the following: Clinical signs indicative of severe systemic
illness, respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, SpO2 ≤93% on room
air at sea level or PaO2/FIO2 <300 mm Hg; or respiratory failure or ARDS (defined as needing
high-flow oxygen, non-invasive or mechanical ventilation, or ECMO), evidence of shock
(systolic blood pressure <90 mmHg, diastolic BP <60 mmHg or requiring vasopressors); or
significant acute renal, hepatic, or neurologic dysfunction; or admission to an intensive care unit
or death.
Among all participants in the Per-Protocol Set analysis, which included COVID-19 cases
confirmed by an adjudication committee, no cases of severe COVID-19 were reported in the
Moderna COVID-19 Vaccine group compared with 30 cases reported in the placebo group
(incidence rate 9.138 per 1,000 person-years). One PCR-positive case of severe COVID-19 in a
vaccine recipient was awaiting adjudication at the time of the analysis.
18.2 Effectiveness of Two-Dose Primary Series in Individuals 6 Months Through 5 Years of

Age
Study 4 includes an ongoing Phase 2/3 randomized, placebo-controlled, observer-blind, clinical

trial component to evaluate the safety, reactogenicity, and effectiveness of the Moderna COVID-
19 Vaccine in individuals ages 6 months through 5 years in the United States and Canada
(NCT04796896). Participants with a known history of SARS-CoV-2 infection within 2 weeks of
study vaccination were excluded from the study. A total of 6,403 participants were randomized
3:1 to receive 2 doses of the Moderna COVID-19 Vaccine or saline placebo 1 month apart.
Participants will be followed for occurrence of COVID-19 and safety until 1 year after the last
dose.
Effectiveness in individuals 6 months through 5 years of age is based on a comparison of

immune responses in this age group to adults 18 years through 25 years of age.
In Study 4, an analysis was conducted of SARS-CoV-2 neutralizing antibody concentrations and

seroresponse rates 28 days after Dose 2 in a subset of individuals 6 months through 5 years of
age in Study 4 and participants 18 years through 25 years of age in Study 1 who had no
immunologic or virologic evidence of prior SARS-CoV-2 at baseline. Noninferior immune
responses as assessed by neutralizing antibody concentrations in arbitrary units (AU)/mL and
seroresponse rates were demonstrated in a comparison of individuals 6 months through 23
months of age to participants 18 years through 25 years of age (Table 6) and 2 years through 5
years of age to participants 18 years through 25 years of age (Table 7).
Table 6: Summary of Geometric Mean Concentration Ratio and Seroresponse Rate –

Comparison of Individuals 6 Months Through 23 Months of Age to Participants 18 Years
Through 25 Years of Age – Per-Protocol Immunogenicity Set
Moderna COVID-19 Vaccine

6 Months Through 18 Years Through 6 Months Through 23 Months/
23 Months 25 Years 18 Years Through 25 Years
n=230 n=291
Assay Time GMC GMC GMC Ratio Met
Point (95% CI)* (95% CI)* (95% CI)a Noninferiority
Objective
(Y/N)b
1780.7 1390.8 1.3
(1606.4, 1973.8) (1269.1, 1524.2) (1.1, 1.5)
SARS-CoV-2 28 days Difference in

neutralization after Seroresponse Seroresponse Seroresponse Y
assayc Dose 2 % % Rate %
(95% CI)d (95% CI)d (95% CI)e
100 99.3 0.7
(98.4, 100) (97.5, 99.9) (-1.0, 2.5)
GMC = Geometric mean concentration
n = number of participants with non-missing data at baseline and at Day 57
* Antibody values reported as below the lower limit of quantification (LLOQ) are replaced by 0.5 x LLOQ. Values
greater than the upper limit of quantification (ULOQ) are replaced by the ULOQ if actual values are not available.
a
The log-transformed antibody levels are analyzed using an analysis of covariance (ANCOVA) model with the
group variable (individuals in Study 4 and young adults in Study 1) as fixed effect. The resulted LS means,
difference of LS means, and 95% CI are back transformed to the original scale for presentation.
b
Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMC ratio is greater than 0.67, with a
point estimate of >0.8 and the lower bound of the 2-sided 95% CI for difference in seroresponse rate is greater
than -10%, with a point estimate of >-5%.
c
Final geometric mean antibody concentrations (GMC) in AU/mL were determined using SARS-CoV-2
microneutralization assay. The SARS CoV-2 MN is a cell-based assay that is designed to determine the ability of
SARS-CoV-2 neutralizing antibodies to inhibit the infection of 293T-ACE2 cells by SARS-CoV-2 Reporter Virus
Particles (RVP) which express green fluorescent protein (GFP). A given serum sample is pre-incubated with a
known quantity of SARS-CoV-2-GFP for 60 (±5) minutes prior to infection of 293T-ACE2 cells. COVID-19
infection is monitored 48 (±4) hours following infection by counting the number of green fluorescent cells using
the Cytation 5 cell imaging reader.
d
Seroresponse due to vaccination specific to SARS-CoV-2 RVP neutralizing antibody concentration at a subject
level is defined in protocol as a change from below LLOQ to equal or above 4 x LLOQ, or at least a 4-fold rise if
baseline is equal to or above LLOQ. Seroresponse 95% CI is calculated using the Clopper-Pearson method.
e
Difference in seroresponse rate 95% CI is calculated using the Miettinen-Nurminen (score) confidence limits.
Table 7: Summary of Geometric Mean Concentration Ratio and Seroresponse Rate –

Comparison of Individuals 2 Years Through 5 Years of Age to Participants 18 Years
Through 25 Years of Age – Per-Protocol Immunogenicity Set
Moderna COVID-19 Vaccine

2 Years Through 18 Years Through 2 Years Through 5 Years/
5 Years 25 Years 18 Years Through 25 Years
n=264 n=291
Assay Time GMC GMC GMC Ratio Met
Point (95% CI)* (95% CI)* (95% CI)a Noninferiority
Objective
(Y/N)b
1410.0 1390.8 1.0
(1273.8, 1560.8) (1262.5, 1532.1) (0.9, 1.2)
SARS-CoV-2 28 days Difference in

neutralization after Seroresponse Seroresponse Seroresponse Y
assayc Dose 2 % % Rate %
(95% CI)d (95% CI)d (95% CI)e
98.9 99.3 -0.4
(96.7, 99.8) (97.5, 99.9) (-2.7, 1.5)
GMC = Geometric mean concentration

n = number of participants with non-missing data at baseline and at Day 57
* Antibody values reported as below the lower limit of quantification (LLOQ) are replaced by 0.5 x LLOQ. Values
greater than the upper limit of quantification (ULOQ) are replaced by the ULOQ if actual values are not available.
a
The log-transformed antibody levels are analyzed using an analysis of covariance (ANCOVA) model with the
group variable (individuals in Study 4 and young adults in Study 1) as fixed effect. The resulted LS means,
difference of LS means, and 95% CI are back transformed to the original scale for presentation.
b
Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMC ratio is greater than 0.67, with a
point estimate of >0.8 and the lower bound of the 2-sided 95% CI for difference in seroresponse rate is greater
than -10%, with a point estimate of >-5%.
c
Final geometric mean antibody concentrations (GMC) in AU/mL were determined using SARS-CoV-2
microneutralization assay. The SARS CoV-2 MN is a cell-based assay that is designed to determine the ability of
SARS-CoV-2 neutralizing antibodies to inhibit the infection of 293T-ACE2 cells by SARS-CoV-2 Reporter Virus
Particles (RVP) which express green fluorescent protein (GFP). A given serum sample is pre-incubated with a
known quantity of SARS-CoV-2-GFP for 60 (±5) minutes prior to infection of 293T-ACE2 cells. COVID-19
infection is monitored 48 (±4) hours following infection by counting the number of green fluorescent cells using
the Cytation 5 cell imaging reader.
d
Seroresponse due to vaccination specific to SARS-CoV-2 RVP neutralizing antibody concentration at a subject
level is defined in protocol as a change from below LLOQ to equal or above 4 x LLOQ, or at least a 4-fold rise if
baseline is equal to or above LLOQ. Seroresponse 95% CI is calculated using the Clopper-Pearson method.
e
Difference in seroresponse rate 95% CI is calculated using the Miettinen-Nurminen (score) confidence limits.
A descriptive efficacy analysis evaluating confirmed COVID-19 cases accrued up to the data
cutoff date February 21, 2022, was performed in 5,476 participants 6 months through 5 years of
age who received two doses (at 0 and 1 month) of either Moderna COVID-19 Vaccine or
placebo and had a negative baseline SARS-CoV-2 status (referred to as the Per-Protocol Set for
Efficacy) (for participants 6 months through 23 months, vaccine=1,511, placebo=513; for
participants 2 years through 5 years, vaccine=2,594, placebo=858). For participants 6 months
through 23 months in the Per-Protocol Set for Efficacy, 51.2% were male, 48.8% were female,
12.7% were Hispanic or Latino; 78.9% were White, 3.1% were African American, 4.6% were
Asian, 0.2% were American Indian or Alaska Native, 0.0% were Native Hawaiian or Pacific
Islander, 1.8% were other races, and 10.7% were Multiracial. For participants 2 years through 5
years, 50.7% were male, 49.3% were female, 14.0% were Hispanic or Latino, 76.8% were
White, 4.1% were African American, 6.1% were Asian, 0.4% were American Indian or Alaska
Native, 0.3% were Native Hawaiian or Pacific Islander, 1.6% were other races, and 10.3% were
Multiracial. Between participants who received Moderna COVID-19 Vaccine and those who
received placebo, there were no notable differences in demographics.
The median length of follow-up for efficacy post-Dose 2 was 68 days for participants 6 months
through 23 months of age and 71 days for participants 2 years through 5 years of age.
Vaccine efficacy among individuals 6 months through 5 years in Study 4 was evaluated during
the period when the B.1.1.529 (Omicron) variant was the predominant variant in circulation.
The efficacy information in individuals 6 months through 23 months of age and 2 years through
5 years of age are presented in Table 8 and Table 9, respectively.
Table 8: Efficacy Analyses: COVID-19 in Participants 6 Months Through 23 Months of
Age Starting 14 Days After Dose 2 – Per Protocol Set for Efficacy

N=1,511 N=513 % Vaccine
Cases Incidence Rate Cases Incidence Rate Efficacy
(n) of COVID-19 (n) of COVID-19 (95% CI)*
per 1,000 per 1,000
Person-Years Person-Years
COVID-19 Cases - 37 99.981 18 146.042 31.5
Definition 1a (-27.7, 62.0)
COVID-19 Cases - 51 138.239 34 279.822 50.6
Definition 2b (21.4, 68.6)
N = Included 15 individuals aged 2 years to 4 years randomized in the 6 months through 23 months of age group
stratum (12 in the Moderna COVID-19 Vaccine group and 3 in the placebo group), and none of them had a
COVID-19 case starting 14 days after Dose 2.
* Vaccine efficacy defined as 1 — ratio of incidence rate (Moderna COVID-19 Vaccine vs. placebo). The 95% CI
of the ratio is calculated using the exact method conditional upon the total number of cases, adjusting for person-
years.
a
Participant must have experienced at least two of the following systemic symptoms: fever (≥38°C / ≥100.4°F),
chills, myalgia, headache, sore throat, new olfactory and taste disorder(s); or the participant must have experienced
at least one of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or
clinical or radiographical evidence of pneumonia; and the participant must have at least one NP swab, nasal swab,
or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by RT-PCR.
b
Presence of at least one symptom from a list of COVID-19 symptoms and a positive NP swab or saliva sample for
SARS-CoV-2 by RT-PCR. Listed symptoms were fever (temperature >38°C / ≥100.4°F), or chills, cough,
shortness of breath or difficulty breathing, fatigue, muscle aches, or body aches, headache, new loss of taste or
smell, sore throat, congestion or runny nose, nausea, abdominal pain, poor appetite/poor feeding, or vomiting or
diarrhea.
Table 9: Efficacy Analyses: COVID-19 in Participants 2 Years Through 5 Years of Age

Starting 14 Days After Dose 2 – Per-Protocol Set for Efficacy

N=2,594 N=858 % Vaccine
Cases Incidence Rate Cases Incidence Rate Efficacy
(n) of COVID-19 (n) of COVID-19 (95% CI)*
per 1,000 per 1,000
Person-Years Person-Years
COVID-19 Cases - 71 103.761 43 193.528 46.4
Definition 1a (19.8, 63.8)
COVID-19 Cases - 119 175.023 61 276.980 36.8
Definition 2b (12.5, 54.0)
N = Included 25 individuals younger than 2 years of age randomized in the 2 years through 5 years of age group
stratum (18 in the Moderna COVID-19 Vaccine group and 7 in the placebo group), and one in each treatment
group had a COVID-19 case starting 14 days after Dose 2.
* Vaccine efficacy defined as 1 — ratio of incidence rate (Moderna COVID-19 Vaccine vs. placebo). The 95% CI
of the ratio is calculated using the exact method conditional upon the total number of cases, adjusting for person-
years.
a
Participant must have experienced at least two of the following systemic symptoms: fever (≥38°C / ≥100.4°F),
chills, myalgia, headache, sore throat, new olfactory and taste disorder(s); or the participant must have experienced
at least one of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or
clinical or radiographical evidence of pneumonia; and the participant must have at least one NP swab, nasal swab,
or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by RT-PCR.
b
Presence of at least one symptom from a list of COVID-19 symptoms and a positive NP swab or saliva sample for
SARS-CoV-2 by RT-PCR. Listed symptoms were fever (temperature >38°C / ≥100.4°F), or chills, cough,
shortness of breath or difficulty breathing, fatigue, muscle aches, or body aches, headache, new loss of taste or
smell, sore throat, congestion or runny nose, nausea, abdominal pain, poor appetite/poor feeding, or vomiting or
diarrhea.
18.3 Immunogenicity in Solid Organ Transplant Recipients
Immunogenicity of the Moderna COVID-19 Vaccine in children with immunocompromise has

been extrapolated from adult data. An independent randomized-controlled study has been
conducted in 120 adult participants who had undergone various solid organ transplant procedures
(heart, kidney, kidney-pancreas, liver, lung, pancreas) a median of 3.57 years previously (range
1.99-6.75 years). A third primary series dose of the Moderna COVID-19 Vaccine was
administered to 60 participants approximately 2 months after they had received a second dose;
saline placebo was given to 60 individuals for comparison. Significant increases in levels of
SARS-CoV-2 antibodies occurred four weeks after the third dose in 55.0% of participants in the
Moderna COVID-19 Vaccine group (33 of 60) and 17.5% of participants in the placebo group
(10 of 57).
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 dark blue caps and labels with a magenta border containing a volume of
2.5 mL. These multiple-dose vials are supplied as follows:
NDC 80777-279-99 Carton of 10 multiple-dose vials, each containing 10 doses of 0.25 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

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

[email protected] 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: Aug/31/2022

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FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING

VACCINE (VACCINATION PROVIDERS)

PRIMARY SERIES PRESENTATION

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

DOSAGE AND ADMINISTRATION

Storage and Handling

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)

Dosing and Schedule

Preparation for Administration

Thaw in Refrigerator Thaw at Room Temperature

• After thawing, do not refreeze.

Management of Acute Allergic Reactions

Myocarditis and Pericarditis

Limitations of Vaccine Effectiveness

Adverse Reactions in Clinical Trials

Adverse reactions in individuals 24 months through 36 months of age following administration

Adverse reactions in individuals 37 months through 5 years of age following administration of

Adverse Reactions in Post-Authorization Experience

USE WITH OTHER VACCINES

INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS

MANDATORY REQUIREMENTS FOR MODERNA COVID-19 VACCINE

3. The vaccination provider must include vaccination information in the state/local

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html.

*Serious adverse events are defined as:

Email Fax number Telephone number

[email protected] 1-866-599-1342 1-866-MODERNA

Website Telephone number

FEDERAL COVID-19 VACCINATION PROGRAM

COUNTERMEASURES INJURY COMPENSATION PROGRAM

Moderna US, Inc.

©2022 ModernaTX, Inc. All rights reserved.

END SHORT VERSION FACT SHEET

MODERNA COVID-19 VACCINE

FULL EUA PRESCRIBING INFORMATION: CONTENTS* 10 DRUG INTERACTIONS

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

Thawing Instructions for Moderna COVID-19 Vaccine Multiple-Dose Vials with

Thaw in Refrigerator Thaw at Room Temperature

• After thawing, do not refreeze.

Administer the Moderna COVID-19 Vaccine intramuscularly.

2.3 Dosing and Schedule

3 DOSAGE FORMS AND STRENGTHS

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment to manage immediate allergic reactions must be immediately

5.2 Myocarditis and Pericarditis

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly

Syncope (fainting) may occur in association with administration of injectable vaccines.

5.4 Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may

5.5 Limitations of Vaccine Effectiveness

6 OVERALL SAFETY SUMMARY

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event

6.1 Clinical Trials Experience

Study 1 (NCT04470427) is a Phase 3 randomized, placebo-controlled, observer-blind clinical

Individuals 6 Months Through 5 Years of Age