Burk Declaration

Date: 2021-12-17

Summary

Document 40-13 in Case 2:21-cv-00702-CLM in the U.S. District Court (N.D. of Alabama), filed December 17, 2021, labeled Burk Declaration Exhibit 13. It reproduces the FDA Fact Sheet for Healthcare Providers Administering Vaccine for the Emergency Use Authorization of the Moderna COVID-19 Vaccine, followed by the Full EUA Prescribing Information. The fact sheet covers storage and handling, a primary series of two 0.5 mL doses and a 0.25 mL booster dose, contraindications, warnings including myocarditis and pericarditis, adverse reactions, and mandatory reporting requirements for vaccination providers. The 36-page document ends with patient counseling and contact information from Moderna US, Inc.

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Full text

Case 2:21-cv-00702-CLM Document 40-13 Filed 12/17/21 Page 1 of 36 FILED
2021 Dec-17 PM 01:27
U.S. DISTRICT COURT
N.D. OF ALABAMA

Burk Declaration
Exhibit 13
Case 2:21-cv-00702-CLM Document 40-13 Filed 12/17/21 Page 2 of 36

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)

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 18 years of age and
older.

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 Multisystem Inflammatory
Syndrome (MIS) in adults, and cases of COVID-19 that result in hospitalization or death
following administration of the Moderna COVID-19 Vaccine. See “MANDATORY
REQUIREMENTS FOR MODERNA COVID-19 VACCINE ADMINISTRATION UNDER
EMERGENCY USE AUTHORIZATION” for reporting requirements.

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

Primary Series:
Each primary series dose of the Moderna COVID-19 Vaccine is 0.5 mL.

The Moderna COVID-19 Vaccine is administered as a primary series of two doses (0.5 mL each)
1 month apart to individuals 18 years of age or older.

A third primary series dose of the Moderna COVID-19 Vaccine (0.5 mL) at least 1 month
following the second dose is authorized for administration to individuals at least 18 years of age
who have undergone solid organ transplantation, or who are diagnosed with conditions that are
considered to have an equivalent level of immunocompromise.

Booster Dose:
The booster dose of the Moderna COVID-19 Vaccine is 0.25 mL.

A single Moderna COVID-19 Vaccine booster dose (0.25 mL) may be administered
intramuscularly at least 6 months after completing a primary series of the Moderna COVID-19
Vaccine to individuals:
• 65 years of age and older
• 18 through 64 years of age at high risk of severe COVID-19
• 18 through 64 years of age with frequent institutional or occupational exposure to SARS-
CoV-2

A single booster dose of the Moderna COVID-19 Vaccine (0.25 mL) may be administered as a
heterologous booster dose following completion of primary vaccination with another authorized
or approved COVID-19 vaccine. The eligible population(s) and dosing interval for the
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heterologous booster dose are the same as those authorized for a booster dose of the vaccine used
for primary vaccination.

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.

The Moderna COVID-19 Vaccine multiple-dose vials are stored frozen between -50º to -15ºC
(-58º to 5ºF). Store in the original carton to protect from light.

Do not store on dry ice or below -50ºC (-58ºF). Use of dry ice may subject vials to temperatures
colder than -50°C (-58°F).

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

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

After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to
77°F). Vials should be discarded 12 hours after the first puncture.

Thawed vials can be handled in room light conditions.

Do not refreeze once thawed.

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

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

Dosing and Schedule

Primary Series:
Each primary series dose of the Moderna COVID-19 Vaccine is 0.5 mL.

The Moderna COVID-19 Vaccine is administered as a primary series of two doses (0.5 mL each)
1 month apart to individuals 18 years of age or older.

Booster Dose:
The booster dose of the Moderna COVID-19 Vaccine is 0.25 mL.

A single booster dose of the Moderna COVID-19 Vaccine (0.25 mL) may be administered as a
heterologous booster dose following completion of primary vaccination with another authorized
or approved COVID-19 vaccine. The eligible population(s) and dosing interval for the
heterologous booster dose are the same as those authorized for a booster dose of the vaccine used
for primary vaccination.

Dose Preparation
• The Moderna COVID-19 Vaccine multiple-dose vials contain a frozen suspension that
does not contain a preservative and must be thawed prior to administration.
• Remove the required number of vial(s) from storage and thaw each vial before use
following the instructions below.

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Multiple-dose Thaw in Refrigerator Thaw at Room Temperature
Vials
Containing

5.5 mL Thaw in refrigerated conditions Alternatively, thaw at room
between 2° to 8°C (36° to 46°F) temperature between 15° to
for 2 hours and 30 minutes. Let 25°C (59° to 77°F) for 1 hour.
each vial stand at room
temperature for 15 minutes
before administering.
7.5 mL Thaw in refrigerated conditions Alternatively, thaw at room
between 2° to 8°C (36° to 46°F) temperature between 15° to
for 3 hours. Let each vial stand 25°C (59° to 77°F) for 1 hour
at room temperature for 15 and 30 minutes.
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.
• The Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain
white or translucent product-related particulates. Visually inspect the Moderna COVID-
19 Vaccine vials for other particulate matter and/or discoloration prior to administration.
If either of these conditions exists, the vaccine should not be administered.
• The Moderna COVID-19 Vaccine is supplied in two multiple-dose vial presentations:
o A multiple-dose vial containing 5.5 mL
o A multiple-dose vial containing 7.5 mL
• Primary series doses of 0.5 mL and booster doses of 0.25 mL may be extracted from
either vial presentation, preferentially using low dead-volume syringes and/or needles.
• When extracting only primary series doses, depending on the syringes and needles used,
a maximum of 11 doses (range: 10-11 doses) may be extracted from the vial containing
5.5 mL or a maximum of 15 doses (range: 13-15 doses) may be extracted from the vial
containing 7.5 mL.
• When extracting only booster doses or a combination of primary series and booster doses,
the maximum number of doses that may be extracted from either vial presentation should
not exceed 20 doses. Do not puncture the vial stopper more than 20 times.
• Irrespective of the type of syringe and needle:
o Each primary series dose must contain 0.5 mL of vaccine.
o Each booster dose must contain 0.25 mL of vaccine.
o If the vial stopper has been punctured 20 times, discard the vial and contents.
o If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5
mL or 0.25 mL, discard the vial and contents. Do not pool excess vaccine from
multiple vials.
• After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36°
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.

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Administration
Visually inspect each dose of the Moderna COVID-19 Vaccine in the dosing syringe prior to
administration. The white to off-white suspension may contain white or translucent product-
related particulates. During the visual inspection,
• verify the final dosing volume of 0.5 mL for a primary series dose or 0.25 mL for a
booster dose.
• confirm there are no other particulates and that no discoloration is observed.
• do not administer if vaccine is discolored or contains other particulate matter.

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 higher among males under 40
years of age than among females and older males. 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.
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Limitations of Vaccine Effectiveness
The Moderna COVID-19 Vaccine may not protect all vaccine recipients.

ADVERSE REACTIONS

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

Adverse Reactions in Post-Authorization Experience
Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been
reported following administration of the Moderna COVID-19 Vaccine during mass vaccination
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
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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):
• vaccine administration errors whether or not associated with an adverse event,
• serious adverse events* (irrespective of attribution to vaccination),
• cases of Multisystem Inflammatory Syndrome (MIS) in adults, 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 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:
• Death;
• A life-threatening adverse event;

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• 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

ModernaPV@modernatx.com 1-866-599-1342 1-866-MODERNA
(1-866-663-3762)

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

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

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

AVAILABLE ALTERNATIVES
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
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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

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END SHORT VERSION FACT SHEET
Long Version (Full EUA Prescribing Information) Begins On Next Page

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FULL EMERGENCY USE AUTHORIZATION (EUA)
PRESCRIBING INFORMATION

MODERNA COVID-19 VACCINE

FULL EUA PRESCRIBING INFORMATION: CONTENTS* 11 USE IN SPECIFIC POPULATIONS
1 AUTHORIZED USE 11.1 Pregnancy
2 DOSAGE AND ADMINISTRATION 11.2 Lactation
2.1 Preparation for Administration 11.3 Pediatric Use
2.2 Administration 11.4 Geriatric Use
2.3 Dosing and Schedule 11.5 Use in Immunocompromised
3 DOSAGE FORMS AND STRENGTHS 13 DESCRIPTION
4 CONTRAINDICATIONS 14 CLINICAL PHARMACOLOGY
5 WARNINGS AND PRECAUTIONS 14.1 Mechanism of Action
5.1 Management of Acute Allergic Reactions 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA
5.2 Myocarditis and Pericarditis FOR EUA
5.3 Syncope 18.1 Efficacy of Two-Dose Primary Series
5.4 Altered Immunocompetence 18.2 Immunogenicity in Solid Organ Transplant Recipients
5.5 Limitations of Vaccine Effectiveness 18.3 Immunogenicity of a Booster Dose Following a Moderna
6 OVERALL SAFETY SUMMARY COVID-19 Vaccine Primary Series
6.1 Clinical Trials Experience 18.4 Immunogenicity of a Booster Dose Following Primary
6.2 Post-Authorization Experience Vaccination with Another Authorized or Approved COVID-19
8 REQUIREMENTS AND INSTRUCTIONS FOR Vaccine
REPORTING ADVERSE EVENTS AND VACCINE 19 HOW SUPPLIED/STORAGE AND HANDLING
ADMINISTRATION ERRORS 20 PATIENT COUNSELING INFORMATION
10 DRUG INTERACTIONS 21 CONTACT INFORMATION
*Sections or subsections omitted from the full prescribing
information are not listed

______________________________________________________________________________

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 18 years of age
and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

• The Moderna COVID-19 Vaccine multiple-dose vials contain a frozen suspension that
does not contain a preservative and must be thawed prior to administration.
• Remove the required number of vial(s) from storage and thaw each vial before use
following the instructions below.

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Multiple- Thaw in Refrigerator Thaw at Room Temperature
dose Vials
Containing

5.5 mL Thaw in refrigerated conditions Alternatively, thaw at room
between 2° to 8°C (36° to 46°F) temperature between 15° to
for 2 hours and 30 minutes. Let 25°C (59° to 77°F) for 1 hour.
each vial stand at room
temperature for 15 minutes
before administering.
7.5 mL Thaw in refrigerated conditions Alternatively, thaw at room
between 2° to 8°C (36° to 46°F) temperature between 15° to
for 3 hours. Let each vial stand at 25°C (59° to 77°F) for 1 hour
room temperature for 15 minutes and 30 minutes.
before administering.

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2.2 Administration

Visually inspect each dose of the Moderna COVID-19 Vaccine in the dosing syringe prior to
administration. The white to off-white suspension may contain white or translucent product-related
particulates. During the visual inspection,
• verify the final dosing volume of 0.5 mL for a primary series dose or 0.25 mL for a booster
dose.
• confirm there are no other particulates and that no discoloration is observed.
• do not administer if vaccine is discolored or contains other particulate matter.

Administer the Moderna COVID-19 Vaccine intramuscularly.

2.3 Dosing and Schedule

Primary Series:
Each primary series dose of the Moderna COVID-19 Vaccine is 0.5 mL.

The Moderna COVID-19 Vaccine is administered as a primary series of two doses (0.5 mL each)
1 month apart to individuals 18 years of age or older.

Booster Dose:
The booster dose of the Moderna COVID-19 Vaccine is 0.25 mL.

A single booster dose of the Moderna COVID-19 Vaccine (0.25 mL) may be administered as a
heterologous booster dose following completion of primary vaccination with another authorized
or approved COVID-19 vaccine. The eligible population(s) and dosing interval for the
heterologous booster dose are the same as those authorized for a booster dose of the vaccine used
for primary vaccination.

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3 DOSAGE FORMS AND STRENGTHS

Moderna COVID-19 Vaccine is a suspension for intramuscular injection.
• Each primary series dose is 0.5 mL.
• The booster dose 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.

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 higher among males under 40
years of age than among females and older males. 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.

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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 Multisystem Inflammatory Syndrome (MIS) in adults, and hospitalized or fatal
cases of COVID-19 following vaccination with the Moderna COVID-19 Vaccine. 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 18 years of age and older following
administration of the primary series included pain at the injection site (92.0%), fatigue (70.0%),
headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting
(23.0%), axillary swelling/tenderness (19.8%), fever (15.5%), swelling at the injection site
(14.7%), and erythema at the injection site (10.0%).

In a clinical study, the adverse reactions in participants 18 years of age and older following
administration of a booster dose included pain at the injection site (83.8%), fatigue (58.7%),
headache (55.1%), myalgia (49.1%), arthralgia (41.3%), chills (35.3%), axillary
swelling/tenderness (20.4%), nausea/vomiting (11.4%), fever (6.6%), swelling at the injection
site (5.4%), and erythema at the injection site (4.8%), rash (1.8%).

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, 15,419 participants aged 18 years and older received at least one dose of Moderna
COVID-19 Vaccine in three clinical trials (NCT04283461, NCT04405076, and NCT04470427).
In a fourth clinical trial (NCT04885907), 60 solid organ transplant recipients received a third
dose of Moderna COVID-19 Vaccine.

Two-Dose Primary Series

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 30,351
participants 18 years of age and older who received at least one dose (0.5 mL) of Moderna
COVID-19 Vaccine (n=15,185) or placebo (n=15,166) (Study 1, NCT04470427). At the time of
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participants (n=3,277) who received placebo. In these analyses, 87.9% of study participants had
at least 28 days of follow-up after Dose 2.

Lymphadenopathy-related events that were not necessarily captured in the 7-day e-diary were
reported by 1.1% of vaccine recipients and 0.6% of placebo recipients. These events included
lymphadenopathy, lymphadenitis, lymph node pain, vaccination-site lymphadenopathy,
injection-site lymphadenopathy, and axillary mass, which were plausibly related to vaccination.
This imbalance is consistent with the imbalance observed for solicited axillary
swelling/tenderness in the injected arm.

Hypersensitivity adverse events were reported in 1.5% of vaccine recipients and 1.1% 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 1.2% of vaccine recipients and 0.4% of placebo
recipients. Delayed injection site reactions included pain, erythema, and swelling and are likely
related to vaccination.

Throughout the same period, there were three reports of Bell’s palsy in the Moderna COVID-19
Vaccine group (one of which was a serious adverse event), which occurred 22, 28, and 32 days
after vaccination, and one in the placebo group which occurred 17 days after vaccination.
Currently available information on Bell’s palsy 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 (including other neurologic, neuro-inflammatory, and
thrombotic events) that would suggest a causal relationship to Moderna COVID-19 Vaccine.

Serious Adverse Events

As of November 25, 2020, serious adverse events were reported by 1.0% (n=147) of participants
who received Moderna COVID-19 Vaccine and 1.0% (n=153) of participants who received
placebo, one of which was the case of Bell’s palsy which occurred 32 days following receipt of
vaccine.

In these analyses, 87.9% of study participants had at least 28 days of follow-up after Dose 2, and
the median follow-up time for all participants was 9 weeks after Dose 2.

There were two serious adverse events of facial swelling in vaccine recipients with a history of
injection of dermatological fillers. The onset of swelling was reported 1 and 2 days, respectively,
after vaccination and was likely related to vaccination.

There was one serious adverse event of intractable nausea and vomiting in a participant with
prior history of severe headache and nausea requiring hospitalization. This event occurred 1 day
after vaccination and was likely related to vaccination.

There were no other notable patterns or imbalances between treatment groups for specific
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completed primary vaccination with another authorized or approved COVID-19 Vaccine
(heterologous booster dose) is inferred from the safety of a Moderna COVID-19 Vaccine (0.25
mL) booster dose administered following completion of a Moderna COVID-19 Vaccine primary
series (homologous booster dose) and from data from an independent Phase 1/2 open-label
clinical trial (NCT04889209) conducted in the United States that evaluated a heterologous
booster dose (0.5 mL) of the Moderna COVID-19 Vaccine. In this study, adults who had
completed primary vaccination with a Moderna COVID-19 Vaccine 2-dose series (N=151), a
Janssen COVID-19 Vaccine single dose (N=156), or a Pfizer-BioNTech COVID-19 Vaccine 2-
dose series (N=151) at least 12 weeks prior to enrollment and who reported no history of SARS-
CoV-2 infection were randomized 1:1:1 to receive a booster dose of one of three vaccines:
Moderna COVID-19 Vaccine (0.5 mL), Janssen COVID-19 Vaccine, or Pfizer-BioNTech
COVID-19 Vaccine. Adverse events were assessed through 28 days after the booster dose. An
overall review of adverse reactions reported following the Moderna COVID-19 Vaccine
heterologous booster dose (0.5 mL) did not identify any new safety concerns, as compared with
adverse reactions reported following Moderna COVID-19 Vaccine primary series doses or
homologous booster dose (0.25 mL).

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 ERRORS

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

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible
for the MANDATORY reporting of the listed events following Moderna COVID-19 Vaccine to
the Vaccine Adverse Event Reporting System (VAERS)
• Vaccine administration errors whether or not associated with an adverse event
• Serious adverse events* (irrespective of attribution to vaccination)
• Cases of Multisystem Inflammatory Syndrome (MIS) in adults
• 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;

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• A persistent or significant incapacity or substantial disruption of the ability to conduct
normal life functions;
• A congenital anomaly/birth defect;
• An important medical event that based on appropriate medical judgement may jeopardize
the individual and may require medical or surgical intervention to prevent one of the
outcomes listed above.

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should
complete and submit a VAERS form to FDA using one of the following methods:
• Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or
• If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-
721-0366. If you need additional help submitting a report, you may call the VAERS toll-
free information line at 1-800-822-7967 or send an email to info@vaers.org.

IMPORTANT: When reporting adverse events or vaccine administration errors to
VAERS, please complete the entire form with detailed information. It is important that the
information reported to FDA be as detailed and complete as possible. Information to
include:
• Patient demographics (e.g., patient name, date of birth)
• Pertinent medical history
• Pertinent details regarding admission and course of illness
• Concomitant medications
• Timing of adverse event(s) in relationship to administration of Moderna COVID-19
Vaccine
• Pertinent laboratory and virology information
• Outcome of the event and any additional follow-up information if it is available at the
time of the VAERS report. Subsequent reporting of follow-up information should be
completed if additional details become available.

The following steps are highlighted to provide the necessary information for safety tracking:
1. In Box 17, provide information on Moderna COVID-19 Vaccine and any other vaccines
administered on the same day; and in Box 22, provide information on any other vaccines
received within one month prior.
2. In Box 18, description of the event:
a. Write “Moderna COVID-19 Vaccine EUA” as the first line
b. Provide a detailed report of vaccine administration error and/or adverse event. It
is important to provide detailed information regarding the patient and adverse
event/medication error for ongoing safety evaluation of this unapproved vaccine.
Please see information to include listed above.
3. Contact information:
a. In Box 13, provide the name and contact information of the prescribing healthcare
provider or institutional designee who is responsible for the report.
b. In Box 14, provide the name and contact information of the best doctor/healthcare

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professional to contact about the adverse event.
c. In Box 15, provide the address of the facility where vaccine was given (NOT the
healthcare provider’s office address).

Other Reporting Instructions

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

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

Email Fax number Telephone number

ModernaPV@modernatx.com 1-866-599-1342 1-866-MODERNA
(1-866-663-3762)

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

11.1 Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to
Moderna COVID-19 Vaccine during pregnancy. Women who are vaccinated with Moderna
COVID-19 Vaccine during pregnancy are encouraged to enroll in the registry by calling 1-866-
MODERNA (1-866-663-3762).

Risk Summary

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general
population, the estimated background risk of major birth defects and miscarriage in clinically
recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on Moderna
COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-
associated risks in pregnancy.

In a developmental toxicity study, 0.2 mL of a vaccine formulation containing the same quantity
of nucleoside-modified messenger ribonucleic acid (mRNA) (100 mcg) and other ingredients
included in a single human dose of Moderna COVID-19 Vaccine was administered to female rats
by the intramuscular route on four occasions: 28 and 14 days prior to mating, and on gestation
days 1 and 13. No vaccine-related adverse effects on female fertility, fetal development, or
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postnatal development were reported in the study.

11.2 Lactation

Risk Summary

Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed
infant or on milk production/excretion.

11.3 Pediatric Use

Safety and effectiveness have not been assessed in persons less than 18 years of age. Emergency
Use Authorization of Moderna COVID-19 Vaccine does not include use in individuals younger
than 18 years of age.

11.4 Geriatric Use

Clinical studies of Moderna COVID-19 Vaccine included participants 65 years of age and older
receiving vaccine or placebo, and their data contribute to the overall assessment of safety and
efficacy. In an ongoing Phase 3 clinical study (Study 1) of primary series dosing (0.5 mL),
24.8% (n=7,520) of participants were 65 years of age and older and 4.6% (n=1,399) of
participants were 75 years of age and older. Vaccine efficacy in participants 65 years of age and
older was 86.4% (95% CI 61.4, 95.2) compared to 95.6% (95% CI 90.6, 97.9) in participants 18
to <65 years of age [see Clinical Trial Results and Supporting Data for EUA (18)]. Overall,
there were no notable differences in the safety profiles observed in participants 65 years of age
and older and younger participants [see Overall Safety Summary (6.1)].

In an ongoing Phase 2 clinical study (Study 2) of a single booster dose (0.25 mL), 22.2% (n=38)
of participants were 65 years of age and older. This study did not include sufficient numbers of
participants 65 years of age and older to determine whether they respond differently than
younger participants. Some local and systemic adverse reactions were reported in a lower
proportion of participants 65 years of age and older compared to participants 18 through 64 years
of age [see Overall Safety Summary (6.1)].

11.5 Use in Immunocompromised

In an independent study, safety and effectiveness of a third 0.5 mL primary series dose of the
Moderna COVID-19 Vaccine have been evaluated in participants who received solid organ
transplants [see Overall Safety Summary (6.1) and Clinical Trial Results and Supporting Data
for EUA (18.2)]. 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.

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13 DESCRIPTION

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

Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside-modified
messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-
CoV-2 virus. Each 0.5 mL dose of the Moderna COVID-19 Vaccine contains the following
ingredients: a total lipid content of 1.93 mg (SM-102, polyethylene glycol [PEG] 2000
dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine
[DSPC]), 0.31 mg tromethamine, 1.18 mg tromethamine hydrochloride, 0.043 mg acetic acid,
0.20 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of Moderna
COVID-19 Vaccine contains half of these ingredients.

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

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.
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18.3 Immunogenicity of a Booster Dose Following a Moderna COVID-19 Vaccine Primary
Series

Effectiveness of a booster dose of the Moderna COVID-19 Vaccine was based on assessment of
neutralizing antibody titers (ID50) against a pseudovirus expressing the SARS-CoV-2 Spike
protein from a USA_WA1/2020 isolate carrying the D614G mutation. Immunogenicity analyses
compared the ID50 following the booster dose to the ID50 following the primary series.

In an open-label phase of Study 2, participants 18 years of age and older received a single
booster dose (0.25 mL) at least 6 months after completion of the primary series (two doses of 0.5
mL 1 month apart). The primary immunogenicity analysis population included 149 booster dose
participants in Study 2 (including one individual who had only received a single dose of the
primary series) and a random subset of 1055 participants from Study 1 who received two doses
(0.5 mL 1 month apart) of Moderna COVID-19 Vaccine. Study 1 and 2 participants included in
the analysis population had no serologic or virologic evidence of SARS-CoV-2 infection prior to
the first primary series dose and prior to the booster dose, respectively. Among participants
assessed for immunogenicity, 60.4% were female, 6.7% were Hispanic or Latino; 95.3% were
White, 3.4% were Black or African American, 0.7% were Asian, and 0.7% were American
Indian or Alaskan Native; 9.4% were obese (body mass index ≥30 kg/m2). The median age of
Study 2 participants was 56 years of age (range 18-82) and 24.8% of participants were 65 years
of age and older. Study 2 participants included in the primary immunogenicity analysis
population did not have pre-existing medical conditions that would place them at risk of severe
COVID-19. Study 1 participants included in the primary immunogenicity analysis population
were a stratified random sample which reflected the overall primary efficacy analysis population
with regards to demographics and pre-existing medical conditions with a higher percentage of
those ≥65 years of age (33.6%), with risk factors for severe COVID-19 (39.4%), and
communities of color (53.5%).

Immunogenicity analyses included an assessment of ID50 geometric mean titer (GMT) ratio and
difference in seroresponse rates. The analysis of the GMT ratio of ID50 following the booster
dose compared to the primary series met the immunobridging criteria for a booster response.
Seroresponse for a participant was defined as achieving a ≥4-fold rise in ID50 from baseline
(before the booster dose in Study 2 and before the first dose of the primary series in Study 1).
The lower limit of the 2-sided 95% CI for the difference in seroresponse rates between Study 1
and Study 2 was -16.7%, which did not meet the immunobridging criterion for a booster
response (lower limit of 2-sided 95% CI for the percentage difference of ≥ -10%). These
analyses are summarized in Tables 7 and 8.

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Table 7: Neutralizing Antibody Geometric Mean Titers (ID50) Against a Pseudovirus
Expressing the SARS-CoV-2 Spike Protein (USA_WA1/2020 isolate carrying the D614G
mutation) at 28 Days After a Booster Dose in Study 2 vs 28 Days After Completion of the
Primary Series in Study 1, Participants ≥18 Years of Age, Per-Protocol Immunogenicity Set*

Study 2 Study 1 GMT Ratio
Booster Dose Primary Series (Study 2/Study 1)
Na=149 Na=1053 Met Success Criteriac
GMTb (95% CI) GMTb (95% CI)

Lower limit of 95% CI ≥0.67 Criterion: Yes
1802 (1548, 2099) 1027 (968, 1089) 1.8 (1.5, 2.1)
Point Estimate ≥1.0 Criterion: Yes

* Per-Protocol Immunogenicity Set included all subjects who had both baseline (or Study 2 Day 1 for Study 2) and
post-vaccination immunogenicity samples, did not have SARS-CoV-2 infection at baseline (or Study 2 Day 1 for
Study 2), did not have a major protocol deviation that impacted immune response, and had post-injection
immunogenicity assessment at timepoint of primary interest (Day 29 for Study 2 and Day 57 for Study 1).
a
Number of subjects with non-missing data at the corresponding timepoint.
b
Given the lack of randomization in Study 2, the statistical analysis plan pre-specified an analysis of covariance
model for estimating the geometric mean titer that adjusts for differences in age groups (<65 years, ≥65 years).
c
Immunobridging is declared if the lower limit of the 2-sided 95% CI for the GMR is >0.67 and the point estimate
of the GLSM ratio is ≥1.0.
Note: Antibody values < the lower limit of quantitation (LLOQ) are replaced by 0.5 × LLOQ. Values > the upper limit of
quantitation (ULOQ) are replaced by the ULOQ if actual values are not available.
GLSM = Geometric least squares mean
GMR = Geometric mean ratio

Table 8: Seroresponse Rates Against A Pseudovirus Expressing the SARS-CoV-2 Spike Protein
(USA_WA1/2020 isolate carrying the D614G mutation) at 28 Days Post-Booster Dose in Study 2
and 28 Days After Completion of the Primary Series in Study 1, Participants ≥18 Years of Age,
Per-Protocol Immunogenicity Set*

Study 2 Study 1 Difference in
Booster Primary Series Seroresponse
Seroresponsea Seroresponsea Rate
Met Success Criterione
Nb=149 Nb=1050 (Study 2-Study 1)
n (%) (95% CI)c n (%) (95% CI)c % (95% CI)d

131 (87.9) 1033 (98.4)
-10.5 (-16.7, -6.1) Lower limit of 95% CI ≥-10% Criterion: No
(81.6, 92.7) (97.4, 99.1)

* Per-Protocol Immunogenicity Set included all subjects who had both baseline (or Study 2 Day 1 for Study 2) and
post-vaccination immunogenicity samples, did not have SARS-CoV-2 infection at baseline (or Study 2 Day 1 for
Study 2), did not have a major protocol deviation that impacted immune response, and had post-injection
immunogenicity assessment at timepoint of primary interest (Day 29 for Study 2 and Day 57 for Study 1).
a
Seroresponse is defined as ≥4-fold rise of pseudovirus neutralizing antibody titers (ID50) from baseline (pre-booster dose
in Study 2 and pre-dose 1 in Study 1), where baseline titers < LLOQ are set to LLOQ for the analysis.
b
Number of subjects with non-missing data at both baseline and the post-baseline timepoint of interest.
c
95% CI is calculated using the Clopper-Pearson method.
d
95% CI is calculated using the Miettinen-Nurminen (score) confidence limits.
e
Immunobridging is declared if the lower limit of the 2-sided 95% CI for the percentage difference is > -10%.

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Study 2 participants who met the ≥4-fold increase in titer post-booster dose (87.9%) had a lower
baseline GMT of 109 (range of individual titers 9, 4393), whereas Study 2 participants who did
not meet the ≥4-fold increase in titers post-booster had a higher baseline GMT of 492 (range of
individual titers 162, 2239).

An additional descriptive analysis evaluated seroresponse rates using baseline neutralizing
antibody titers prior to dose 1 of the primary series. As shown in Table 9 below, the booster dose
seroresponse rate, with seroresponse defined as at least a 4-fold rise relative to the pre-dose 1
titer, was 100%. The difference in seroresponse rates in this post-hoc analysis was 1.6% (95% CI
-0.9, 2.6).

Table 9: Analysis of Seroresponse Rates Against a Pseudovirus Expressing the SARS-CoV-
2 Spike Protein (USA_WA1/2020 isolate carrying the D614G mutation) at 28 Days Post-
Booster Dose in Study 2 and 28 Days After Completion of the Primary Series in Study 1,
Participants ≥18 Years of Age, Per-Protocol Immunogenicity Set*

Study 2 Study 1
Booster Seroresponsea Primary Series Seroresponsea Difference in Seroresponse Rate
Nb=148 Nc=1050 (After Booster-After Primary Series)
n (%) (95% CI)d n (%) (95% CI)d % (95% CI)e

148 (100) 1033 (98.4)
1.6 (-0.9, 2.6)
(97.5, 100) (97.4, 99.1)

* Per-Protocol Immunogenicity Set included all subjects who had non-missing data at baseline (before dose 1) and
28 days post-booster in Study 2 or 28 days post-dose 2 in the primary series in Study 1, respectively, did not have
SARS-CoV-2 infection at pre-booster in Study 2 or baseline in Study 1, did not have a major protocol deviation
that impacted immune response, and had post-injection immunogenicity assessment at timepoint of primary
interest.
a
Seroresponse is defined as ≥4-fold rise of pseudovirus neutralizing antibody titers (ID50) from pre-dose 1, where
baseline titers < LLOQ are set to LLOQ for the analysis.
b
Number of subjects with non-missing data at baseline (before dose 1) and 28 days post-booster in Study 2.
c
Number of subjects with non-missing data at baseline (before dose 1) and 28 days post-dose 2 in the primary series
in Study 1.
d
95% CI is calculated using the Clopper-Pearson method.
e
95% CI is calculated using the Miettinen-Nurminen (score) confidence limits.

18.4 Immunogenicity of a Booster Dose Following Primary Vaccination with Another
Authorized or Approved COVID-19 Vaccine

Effectiveness of a Moderna COVID-19 Vaccine (0.25 mL) booster dose in individuals who completed
primary vaccination with another authorized or approved COVID-19 Vaccine (heterologous booster
dose) is inferred from immunogenicity data supporting effectiveness of a Moderna COVID-19
Vaccine (0.25 mL) booster dose administered following completion of a Moderna COVID-19 Vaccine
primary series and from immunogenicity data from an independent Phase 1/2 open-label clinical trial
(NCT04889209) conducted in the United States that evaluated a heterologous booster dose (0.5 mL) of
the Moderna COVID-19 Vaccine. In this study, adults who had completed primary vaccination with a
Moderna COVID-19 Vaccine 2-dose series (N=151), a Janssen COVID-19 Vaccine single dose
(N=156), or a Pfizer-BioNTech COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks prior to
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enrollment and who reported no history of SARS-CoV-2 infection were randomized 1:1:1 to receive a
booster dose of one of three vaccines: Moderna COVID-19 Vaccine, Janssen COVID-19 Vaccine, or
Pfizer-BioNTech COVID-19 Vaccine. Neutralizing antibody titers, as measured by a pseudovirus
neutralization assay using a lentivirus expressing the SARS-CoV-2 Spike protein with D614G
mutation, were assessed on Day 1 prior to administration of the booster dose and on Day 15 after the
booster dose. A booster response to the Moderna COVID-19 Vaccine (0.5 mL) was demonstrated
regardless of primary vaccination.

19 HOW SUPPLIED/STORAGE AND HANDLING

Moderna COVID-19 Vaccine Suspension for Intramuscular Injection Multiple-Dose Vials are
supplied as follows:

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

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

During storage, minimize exposure to room light.

Store frozen between -50º to -15ºC (-58º to 5ºF). Store in the original carton to protect from light.

Do not store on dry ice or below -50ºC (-58ºF). Use of dry ice may subject vials to temperatures
colder than -50°C (-58°F).

Vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first
use. Do not refreeze.

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

After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to
77°F). Vials should be discarded 12 hours after the first puncture.

Thawed vials can be handled in room light conditions.

Do not refreeze once thawed.

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

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

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

Moderna US, Inc.
Cambridge, MA 02139

Revised: Oct/20/2021 35

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Original: archive.org

Burk Declaration

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