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 administered as a

series of two doses (0.5 mL each) 1 month apart.

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.

Revised: Aug/27/2021 1
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.

Transportation of Thawed Vials at 2° to 8°C (35° 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 (35° to 46°F) when shipped using
shipping containers which have been qualified to maintain 2° to 8°C (35° 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 (35° to 46°F), vials should not be refrozen and should be stored at 2° to
8°C (35° to 46°F) until use.

Dosing and Schedule

The Moderna COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.5
mL each) 1 month apart.

There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with
other COVID-19 vaccines to complete the vaccination series. Individuals who have received one
dose of the Moderna COVID-19 Vaccine should receive a second dose of the Moderna COVID-
19 Vaccine to complete the vaccination series.

A third dose of the Moderna COVID-19 Vaccine (0.5 mL) administered at least 28 days
following the second dose of this vaccine 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.

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.
Revised: Aug/27/2021 2
 Vial Thaw in Refrigerator Thaw at Room Temperature

Maximum Thaw in refrigerated conditions Alternatively, thaw at room

11-Dose Vial between 2° to 8°C for 2 hours temperature between 15° to
(range: 10-11 and 30 minutes. Let each vial 25°C for 1 hour.
doses) stand at room temperature for 15
minutes before administering.
Maximum Thaw in refrigerated conditions Alternatively, thaw at room
15-Dose Vial between 2° to 8°C for 3 hours. temperature between 15° to
(range: 13-15 Let each vial stand at room 25°C for 1 hour and 30
doses) temperature for 15 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 a maximum of 11 doses: range 10-11 doses (0.5
mL each).
o A multiple-dose vial containing a maximum of 15 doses: range 13-15 doses (0.5
mL each).
• Depending on the syringes and needles used for each dose, there may not be sufficient
volume to extract more than 10 doses from the maximum of 11 doses vial or more than
13 doses from the maximum of 15 doses vial. Irrespective of the type of syringe and
needle:
o Each dose must contain 0.5 mL of vaccine.
o If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5
mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.
o Pierce the stopper at a different site each time.
• 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.

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.
• confirm there are no other particulates and that no discoloration is observed.
• do not administer if vaccine is discolored or contains other particulate matter.

Revised: Aug/27/2021 3
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.

Limitations of Vaccine Effectiveness

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

ADVERSE REACTIONS
Adverse reactions reported in a clinical trial 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, and erythema
at the injection site. (See Full EUA Prescribing Information)
Revised: Aug/27/2021 4
Severe allergic reactions, including anaphylaxis, have been reported following administration of
the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.

Myocarditis and pericarditis 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
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
Revised: Aug/27/2021 5
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;
• 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
Revised: Aug/27/2021 6
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
Comirnaty (COVID-19 Vaccine, mRNA) is an FDA-approved vaccine to prevent COVID-19
caused by SARS-CoV-2. There may be clinical trials or availability under EUA of other
COVID-19 vaccines.

FEDERAL COVID-19 VACCINATION PROGRAM

This vaccine is being made available for emergency use exclusively through the CDC COVID-
19 Vaccination Program (the Vaccination Program). Healthcare providers must enroll as
providers in the Vaccination Program and comply with the provider requirements. Vaccination
providers may not charge any fee for the vaccine and may not charge the vaccine recipient any
out-of-pocket charge for administration. However, vaccination providers may seek appropriate
reimbursement from a program or plan that covers COVID-19 vaccine administration fees for
the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured
Program for non-insured recipients). For information regarding provider requirements and
enrollment in the CDC COVID-19 Vaccination Program, see
https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html.

Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination
Program requirements are encouraged to report them to the Office of the Inspector General, U.S.
Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.

Revised: Aug/27/2021 7
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
[email protected], or call: 1-855-266-2427.

Moderna US, Inc.

Cambridge, MA 02139

©2021 ModernaTX, Inc. All rights reserved.

Patent(s): www.modernatx.com/patents
Revised: Aug/27/2021

END SHORT VERSION FACT SHEET

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

Revised: Aug/27/2021 8
FULL EMERGENCY USE AUTHORIZATION (EUA)
PRESCRIBING INFORMATION

MODERNA COVID-19 VACCINE

FULL EUA PRESCRIBING INFORMATION: CONTENTS* 8 REQUIREMENTS AND INSTRUCTIONS FOR

1 AUTHORIZED USE REPORTING ADVERSE EVENTS AND VACCINE
2 DOSAGE AND ADMINISTRATION ADMINISTRATION ERRORS
2.1 Preparation for Administration 10 DRUG INTERACTIONS
2.2 Administration 11 USE IN SPECIFIC POPULATIONS
2.3 Dosing and Schedule 11.1 Pregnancy
3 DOSAGE FORMS AND STRENGTHS 11.2 Lactation
4 CONTRAINDICATIONS 11.3 Pediatric Use
5 WARNINGS AND PRECAUTIONS 11.4 Geriatric Use
5.1 Management of Acute Allergic Reactions 11.5 Use in Immunocompromised
5.2 Myocarditis and Pericarditis 13 DESCRIPTION
5.3 Syncope 14 CLINICAL PHARMACOLOGY
5.4 Altered Immunocompetence 14.1 Mechanism of Action
5.5 Limitations of Vaccine Effectiveness 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA
6 OVERALL SAFETY SUMMARY FOR EUA
6.1 Clinical Trials Experience 19 HOW SUPPLIED/STORAGE AND HANDLING
6.2 Post-Authorization Experience 20 PATIENT COUNSELING INFORMATION
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.

Revised: Aug/27/2021 9
 Vial Thaw in Refrigerator Thaw at Room Temperature

Maximum Thaw in refrigerated conditions Alternatively, thaw at room

11-Dose Vial between 2° to 8°C for 2 hours temperature between 15° to
(range: 10-11 and 30 minutes. Let each vial 25°C for 1 hour.
doses) stand at room temperature for 15
minutes before administering.
Maximum Thaw in refrigerated conditions Alternatively, thaw at room
15-Dose Vial between 2° to 8°C for 3 hours. temperature between 15° to
(range: 13-15 Let each vial stand at room 25°C for 1 hour and 30
doses) temperature for 15 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 a maximum of 11 doses: range 10-11 doses (0.5
mL each).
o A multiple-dose vial containing a maximum of 15 doses: range 13-15 doses (0.5
mL each).
• Depending on the syringes and needles used for each dose, there may not be sufficient
volume to extract more than 10 doses from the maximum of 11 doses vial or more than
13 doses from the maximum of 15 doses vial. Irrespective of the type of syringe and
needle:
o Each dose must contain 0.5 mL of vaccine.
o If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5
mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.
o Pierce the stopper at a different site each time.
• 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.

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.
• confirm there are no other particulates and that no discoloration is observed.
• do not administer if vaccine is discolored or contains other particulate matter.

Revised: Aug/27/2021 10
Administer the Moderna COVID-19 Vaccine intramuscularly.

2.3 Dosing and Schedule

The Moderna COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.5
mL each) 1 month apart.

There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with
other COVID-19 vaccines to complete the vaccination series. Individuals who have received one
dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19
Vaccine to complete the vaccination series.

A third dose of the Moderna COVID-19 Vaccine (0.5 mL) administered at least 28 days
following the second dose of this vaccine 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.

3 DOSAGE FORMS AND STRENGTHS

Moderna COVID-19 Vaccine is a suspension for intramuscular injection. A single dose is 0.5
mL.

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

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 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
Revised: Aug/27/2021 11
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 Multi-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 clinical studies, the adverse reactions in participants 18 years of age and older were 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%).

Severe allergic reactions, including anaphylaxis, have been reported following administration of
the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.

Myocarditis and pericarditis have been reported following administration of the Moderna
COVID-19 Vaccine during mass vaccination 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).

Revised: Aug/27/2021 12
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 of Moderna COVID-19
Vaccine (n=15,185) or placebo (n=15,166) (NCT04470427). At the time of vaccination, the
mean age of the population was 52 years (range 18-95); 22,831 (75.2%) of participants were 18
to 64 years of age and 7,520 (24.8%) of participants were 65 years of age and older. Overall,
52.7% were male, 47.3% 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, 2.1% were other races, and 2.1% were
Multiracial. Demographic characteristics were similar among participants who received Moderna
COVID-19 Vaccine and those who received placebo.

Solicited Adverse Reactions

Data on solicited local and systemic adverse reactions and use of antipyretic medication were
collected 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 (n=15,179) and
participants receiving placebo (n=15,163) with at least 1 documented dose. Solicited adverse
reactions were reported more frequently among vaccine participants than placebo participants.

The reported number and percentage of the solicited local and systemic adverse reactions by age
group and dose are presented in Table 1 and Table 2, respectively.

Table 1: Number and Percentage of Participants With Solicited Local and Systemic
Adverse Reactions Within 7 Days* After Each Dose in Participants 18-64 Years (Solicited
Safety Set, Dose 1 and Dose 2)

Moderna COVID-19 Vaccine Placeboa

Dose 1 Dose 2 Dose 1 Dose 2

(N=11,406) (N=10,985) (N=11,407) (N=10,918)
n (%) n (%) n (%) n (%)
Local Adverse
Reactions
Pain 9,908 9,873 2,177 2,040
(86.9) (89.9) (19.1) (18.7)
Pain, Grade 3b 366 506 23 22
(3.2) (4.6) (0.2) (0.2)
Axillary 1,322 1,775 567 470
swelling/tenderness (11.6) (16.2) (5.0) (4.3)
Axillary 37 46 13 11
swelling/tenderness, (0.3) (0.4) (0.1) (0.1)
Grade 3b
Swelling (hardness) 767 1,389 34 36
≥25 mm (6.7) (12.6) (0.3) (0.3)
Swelling (hardness), 62 182 3 4
Grade 3c (0.5) (1.7) (<0.1) (<0.1)
Erythema (redness) 344 982 47 43
≥25 mm (3.0) (8.9) (0.4) (0.4)

Revised: Aug/27/2021 13
 Moderna COVID-19 Vaccine Placeboa

Dose 1 Dose 2 Dose 1 Dose 2

(N=11,406) (N=10,985) (N=11,407) (N=10,918)
n (%) n (%) n (%) n (%)
Erythema (redness), 34 210 11 12
Grade 3c (0.3) (1.9) (<0.1) (0.1)
Systemic Adverse
Reactions
Fatigue 4,384 7,430 3,282 2,687
(38.4) (67.6) (28.8) (24.6)
Fatigue, Grade 3d 120 1,174 83 86
(1.1) (10.7) (0.7) (0.8)
Fatigue, Grade 4e 1 0 0 0
(<0.1) (0) (0) (0)
Headache 4,030 6,898 3,304 2,760
(35.3) (62.8) (29.0) (25.3)
Headache, Grade 3f 219 553 162 129
(1.9) (5.0) (1.4) (1.2)
Myalgia 2,699 6,769 1,628 1,411
(23.7) (61.6) (14.3) (12.9)
Myalgia, Grade 3d 73 1,113 38 42
(0.6) (10.1) (0.3) (0.4)
Arthralgia 1,893 4,993 1,327 1,172
(16.6) (45.5) (11.6) (10.7)
Arthralgia, Grade 3d 47 647 29 37
(0.4) (5.9) (0.3) (0.3)
Arthralgia, Grade 4e 1 0 0 0
(<0.1) (0) (0) (0)
Chills 1,051 5,341 730 658
(9.2) (48.6) (6.4) (6.0)
Chills, Grade 3g 17 164 8 15
(0.1) (1.5) (<0.1) (0.1)
Nausea/vomiting 1,068 2,348 908 801
(9.4) (21.4) (8.0) (7.3)
Nausea/vomiting, 6 10 8 8
Grade 3h (<0.1) (<0.1) (<0.1) (<0.1)
Fever 105 1,908 37 39
(0.9) (17.4) (0.3) (0.4)
Fever, Grade 3i 10 184 1 2
(<0.1) (1.7) (<0.1) (<0.1)
Fever, Grade 4j 4 12 4 2
(<0.1) (0.1) (<0.1) (<0.1)
Use of antipyretic or 2,656 6,292 1,523 1,248
pain medication (23.3) (57.3) (13.4) (11.4)

* 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).
a
Placebo was a saline solution.
b
Grade 3 pain and axillary swelling/tenderness: Defined as any use of prescription pain reliever; prevents daily
activity.
c
Grade 3 swelling and erythema: Defined as >100 mm / >10 cm.
d
Grade 3 fatigue, myalgia, arthralgia: Defined as significant; prevents daily activity.
e
Grade 4 fatigue, arthralgia: Defined as requires emergency room visit or hospitalization.

Revised: Aug/27/2021 14
f
Grade 3 headache: Defined as significant; any use of prescription pain reliever or prevents daily activity.
g
Grade 3 chills: Defined as prevents daily activity and requires medical intervention.
h
Grade 3 nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration.
i
Grade 3 fever: Defined as ≥39.0° – ≤40.0°C / ≥102.1° – ≤104.0°F.
j
Grade 4 fever: Defined as >40.0°C / >104.0°F.

Table 2: Number and Percentage of Participants With Solicited Local and Systemic
Adverse Reactions Within 7 Days* After Each Dose in Participants 65 Years and Older
(Solicited Safety Set, Dose 1 and Dose 2)

Moderna COVID-19 Vaccine Placeboa

Dose 1 Dose 2 Dose 1 Dose 2

(N=3,762) (N=3,692) (N=3,748) (N=3,648)
n (%) n (%) n (%) n (%)
Local Adverse
Reactions
Pain 2,782 3,070 481 437
(74.0) (83.2) (12.8) (12.0)
Pain, Grade 3b 50 98 32 18
(1.3) (2.7) (0.9) (0.5)
Axillary 231 315 155 97
swelling/tenderness (6.1) (8.5) (4.1) (2.7)
Axillary 12 21 14 8
swelling/tenderness, (0.3) (0.6) (0.4) (0.2)
Grade 3b
Swelling (hardness) 165 400 18 13
≥25 mm (4.4) (10.8) (0.5) (0.4)
Swelling (hardness), 20 72 3 7
Grade 3c (0.5) (2.0) (<0.1) (0.2)
Erythema (redness) 86 275 20 13
≥25 mm (2.3) (7.5) (0.5) (0.4)
Erythema (redness), 8 77 2 3
Grade 3c (0.2) (2.1) (<0.1) (<0.1)
Systemic Adverse
Reactions
Fatigue 1,251 2,152 851 716
(33.3) (58.3) (22.7) (19.6)
Fatigue, Grade 3d 30 254 22 20
(0.8) (6.9) (0.6) (0.5)
Headache 921 1,704 723 650
(24.5) (46.2) (19.3) (17.8)
Headache, Grade 3e 52 106 34 33
(1.4) (2.9) (0.9) (0.9)
Myalgia 742 1,739 443 398
(19.7) (47.1) (11.8) (10.9)
Myalgia, Grade 3d 17 205 9 10
(0.5) (5.6) (0.2) (0.3)
Arthralgia 618 1,291 456 397
(16.4) (35.0) (12.2) (10.9)
Arthralgia, Grade 3d 13 123 8 7
(0.3) (3.3) (0.2) (0.2)

Revised: Aug/27/2021 15
 Moderna COVID-19 Vaccine Placeboa

Dose 1 Dose 2 Dose 1 Dose 2

(N=3,762) (N=3,692) (N=3,748) (N=3,648)
n (%) n (%) n (%) n (%)
Chills 202 1,141 148 151
(5.4) (30.9) (4.0) (4.1)
Chills, Grade 3f 7 27 6 2
(0.2) (0.7) (0.2) (<0.1)
Nausea/vomiting 194 437 166 133
(5.2) (11.8) (4.4) (3.6)
Nausea/vomiting, 4 10 4 3
Grade 3g (0.1) (0.3) (0.1) (<0.1)
Nausea/vomiting, 0 1 0 0
Grade 4h (0) (<0.1) (0) (0)
Fever 10 370 7 4
(0.3) (10.0) (0.2) (0.1)
Fever, Grade 3i 1 18 1 0
(<0.1) (0.5) (<0.1) (0)
Fever, Grade 4j 0 1 2 1
(0) (<0.1) (<0.1) (<0.1)
Use of antipyretic or 673 1,546 477 329
pain medication (17.9) (41.9) (12.7) (9.0)

* 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).
a
Placebo was a saline solution.
b
Grade 3 pain and axillary swelling/tenderness: Defined as any use of prescription pain reliever; prevents daily
activity.
c
Grade 3 swelling and erythema: Defined as >100 mm / >10 cm.
d
Grade 3 fatigue, myalgia, arthralgia: Defined as significant; prevents daily activity.
e
Grade 3 headache: Defined as significant; any use of prescription pain reliever or prevents daily activity.
f
Grade 3 chills: Defined as prevents daily activity and requires medical intervention.
g
Grade 3 Nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration.
h
Grade 4 Nausea/vomiting: Defined as requires emergency room visit or hospitalization for hypotensive shock.
i
Grade 3 fever: Defined as ≥39.0° – ≤40.0°C / ≥102.1° – ≤104.0°F.
j
Grade 4 fever: Defined as >40.0°C / >104.0°F.

Solicited local and systemic adverse reactions reported following administration of Moderna
COVID-19 Vaccine had a median duration of 1 to 3 days.

Grade 3 solicited local adverse reactions were more frequently reported after Dose 2 than after
Dose 1. Solicited systemic adverse reactions were more frequently reported by vaccine recipients
after Dose 2 than after Dose 1.

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 of 2 years. As of November 25, 2020, among participants
who had received at least 1 dose of vaccine or placebo (vaccine=15,185, placebo=15,166),
unsolicited adverse events that occurred within 28 days following each vaccination were reported
Revised: Aug/27/2021 16
by 23.9% of participants (n=3,632) who received Moderna COVID-19 Vaccine and 21.6% of
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.

In 60 individuals 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.

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.
Revised: Aug/27/2021 17
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
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 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;
• 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.

Revised: Aug/27/2021 18
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

Revised: Aug/27/2021 19
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

11.1 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
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
Revised: Aug/27/2021 20
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, 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)].

11.5 Use in Immunocompromised

Safety and effectiveness of a third dose of the Moderna COVID-19 Vaccine have been tested in
persons that received solid organ transplants. The administration of third vaccine doses appears
to be only moderately effective in increasing antibody titers, so patients should be counselled 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 0.5 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 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.

Moderna COVID-19 Vaccine does not contain a preservative.

The vial stoppers are not made with natural rubber latex.

Revised: Aug/27/2021 21
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

A 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 is ongoing 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), 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
Revised: Aug/27/2021 22
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 3: 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 4.

Table 4: Subgroup Analyses of Vaccine Efficacy: COVID-19* Cases Starting 14 Days After
Dose 2 per Adjudication Committee Assessments – Per- Protocol Set

Moderna COVID-19 Vaccine Placebo

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
Revised: Aug/27/2021 23
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.

A separate randomized-controlled study has been conducted in 120 individuals 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 dose of the
Moderna COVID-19 Vaccine was administered to 60 individuals 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 33/60 (55.0%) of the Moderna COVID-19 Vaccine group and 10/57 (17.5%) of the
placebo group.

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 a maximum of

11 doses: range 10-11 doses (0.5 mL)

NDC 80777-273-98 Carton of 10 multiple-dose vials, each vial containing a maximum of

15 doses: range 13-15 doses (0.5 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.
Revised: Aug/27/2021 24
Thawed vials can be handled in room light conditions.

Do not refreeze once thawed.

Transportation of Thawed Vials at 2°C to 8°C (35°F 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 (35° to 46°F) when shipped using
shipping containers which have been qualified to maintain 2° to 8°C (35° 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 (35° to 46°F), vials should not be refrozen and should be stored at 2° to
8°C (35° 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

©2021 ModernaTX, Inc. All rights reserved.

Patent(s): www.modernatx.com/patents
Revised: Aug/27/2021

Revised: Aug/27/2021 25