FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERINGVACCINE (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 andolder.
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 deathfollowing administration of the Moderna COVID-19 Vaccine. See “MANDATORYREQUIREMENTS 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 aseries of two doses (0.5 mL each) 1 month apart.
See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may havebeen updated. For the most recent Fact Sheet, please see www.modernatx.com/covid19vaccineeua.
For information on clinical trials that are testing the use of the Moderna COVID-19 Vaccine foractive 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 affectother organs. People with COVID-19 have reported a wide range of symptoms, ranging frommild 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 bodyaches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea orvomiting; 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: Jun/24/2021

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 temperaturescolder 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 firstuse.
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° to77°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 underroutine road and air transport conditions with shaking and vibration minimized. Once thawed andtransported 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 (0.5mL each) 1 month apart.
There are no data available on the interchangeability of the Moderna COVID-19 Vaccine withother 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 COVID19 Vaccine to complete the vaccination series.
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: Jun/24/2021

2

Vial

Thaw in Refrigerator

Maximum
11-Dose Vial(range: 10-11
doses)

Thaw in refrigerated conditions
between 2° to 8°C for 2 hours
and 30 minutes. Let each vial
stand at room temperature for 15
minutes before administering.
Thaw in refrigerated conditions
between 2° to 8°C for 3 hours.
Let each vial stand at room
temperature for 15 minutes
before administering.

Maximum
15-Dose Vial(range: 13-15
doses)
•
•
•

•

•

•

Thaw at Room Temperature
Alternatively, thaw at room
temperature between 15° to
25°C for 1 hour.
Alternatively, thaw at room
temperature between 15° to
25°C for 1 hour and 30
minutes.

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 containwhite or translucent product-related particulates. Visually inspect the Moderna COVID19 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 (0.5mL each).
o A multiple-dose vial containing a maximum of 15 doses: range 13-15 doses (0.5mL each).
Depending on the syringes and needles used for each dose, there may not be sufficientvolume 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 andneedle: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 viallabel. Discard vial after 12 hours. Do not refreeze.

Administration
Visually inspect each dose of the Moderna COVID-19 Vaccine in the dosing syringe prior toadministration. The white to off-white suspension may contain white or translucent productrelated 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: Jun/24/2021

3

Administer the Moderna COVID-19 Vaccine intramuscularly.
CONTRAINDICATION
Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of asevere allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19
Vaccine (see Full EUA Prescribing Information).
WARNINGSManagement 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 theModerna 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
Reports of adverse events following use of the Moderna COVID-19 Vaccine under EUA suggest
increased risks of myocarditis and pericarditis, particularly following the second dose. Typically,
onset of symptoms has been within a few days following receipt of the Moderna COVID-19
Vaccine. Available data from short-term follow-up suggest that most individuals have had
resolution of symptoms, but information is not yet available about potential long-term sequelae.
The decision to administer the Moderna COVID-19 Vaccine to an individual with a history of
myocarditis or pericarditis should take into account the individual’s clinical circumstances. The
CDC has published clinical considerations relevant to myocarditis and pericarditis associatedwith administration of the Moderna COVID-19 Vaccine (https://www.cdc.gov/vaccines/covid19/clinical-considerations/myocarditis.html).
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 REACTIONSAdverse 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 erythemaat the injection site. (See Full EUA Prescribing Information)
Severe allergic reactions, including anaphylaxis, have been reported following administration of
the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.
Revised: Jun/24/2021

4

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 morewidespread 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 othervaccines.
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 theFact 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 thosealternatives
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 recipientneeds 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 COVID19 vaccination. For more information, visit: www.cdc.gov/vsafe.
MANDATORY REQUIREMENTS FOR MODERNA COVID-19 VACCINEADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION
In order to mitigate the risks of using this unapproved product under EUA and to optimize thepotential benefit of the Moderna COVID-19 Vaccine, the following items are required. Use ofunapproved Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 under
this EUA is limited to the following (all requirements must be met):
Revised: Jun/24/2021

5

1. The Moderna COVID-19 Vaccine is authorized for use in individuals 18 years of age andolder.
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 thereport.
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 toprevent 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 bereported using the contact information above.

Revised: Jun/24/2021

6

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.
EmailFax 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 orvisit the website provided below.
WebsiteTelephone number

www.modernatx.com/covid19vaccine-eua

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

AVAILABLE ALTERNATIVES
There is no approved alternative vaccine to prevent COVID-19. There may be clinical trials oravailability 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 COVID19 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 forthe vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured
Program for non-insured recipients). For information regarding provider requirements andenrollment 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 EUAThe Secretary of the Department of Health and Human Services (HHS) has declared a public
Revised: Jun/24/2021

7

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 scientificevidence 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 determinesthat the circumstances justifying the EUA no longer exist or when there is a change in theapproval 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-policyframework/emergency-use-authorization.
COUNTERMEASURES INJURY COMPENSATION PROGRAM
The Countermeasures Injury Compensation Program (CICP) is a federal program that has beencreated to help pay for related costs of medical care and other specific expenses to compensate
people injured after use of certain medical countermeasures. Medical countermeasures are
specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the
public during a public health emergency or a security threat. For more information about CICP
regarding the vaccines to prevent COVID-19, visit http://www.hrsa.gov/cicp, email
cicp@hrsa.gov, or call: 1-855-266-2427.
Moderna US, Inc.
Cambridge, MA 02139©2021 ModernaTX, Inc. All rights reserved.
Patent(s): www.modernatx.com/patents
Revised: Jun/24/2021
END SHORT VERSION FACT SHEETLong Version (Full EUA Prescribing Information) Begins On Next Page

Revised: Jun/24/2021

8

FULL EMERGENCY USE AUTHORIZATION (EUA)
PRESCRIBING INFORMATION
MODERNA COVID-19 VACCINE
FULL EUA PRESCRIBING INFORMATION: CONTENTS*
1 AUTHORIZED USE
2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
2.2 Administration
2.3 Dosing and Schedule
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
5.2 Myocarditis and Pericarditis
5.3 Altered Immunocompetence
5.4 Limitations of Vaccine Effectiveness
6 OVERALL SAFETY SUMMARY
6.1 Clinical Trials Experience
6.2 Post-Authorization Experience

8 REQUIREMENTS AND INSTRUCTIONS FORREPORTING ADVERSE EVENTS AND VACCINEADMINISTRATION ERRORS
10 DRUG INTERACTIONS
11 USE IN SPECIFIC POPULATIONS
11.1 Pregnancy
11.2 Lactation
11.3 Pediatric Use
11.4 Geriatric Use
13 DESCRIPTION
14 CLINICAL PHARMACOLOGY
14.1 Mechanism of Action
18 CLINICAL TRIAL RESULTS AND SUPPORTING DATAFOR EUA
19 HOW SUPPLIED/STORAGE AND HANDLING
20 PATIENT COUNSELING INFORMATION
21 CONTACT INFORMATION*Sections or subsections omitted from the full prescribing
information are not listed______________________________________________________________________________
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 bysevere 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: Jun/24/2021

9

Vial

Thaw in Refrigerator

Maximum
11-Dose Vial(range: 10-11
doses)

Thaw in refrigerated conditions
between 2° to 8°C for 2 hours
and 30 minutes. Let each vial
stand at room temperature for 15
minutes before administering.
Thaw in refrigerated conditions
between 2° to 8°C for 3 hours.
Let each vial stand at room
temperature for 15 minutes
before administering.

Maximum
15-Dose Vial(range: 13-15
doses)
•
•
•

•

•

•

Thaw at Room Temperature
Alternatively, thaw at room
temperature between 15° to
25°C for 1 hour.
Alternatively, thaw at room
temperature between 15° to
25°C for 1 hour and 30
minutes.

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 containwhite or translucent product-related particulates. Visually inspect the Moderna COVID19 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 (0.5mL each).
o A multiple-dose vial containing a maximum of 15 doses: range 13-15 doses (0.5mL each).
Depending on the syringes and needles used for each dose, there may not be sufficientvolume 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 andneedle: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 viallabel. 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 toadministration. The white to off-white suspension may contain white or translucent product-relatedparticulates. 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: Jun/24/2021

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 (0.5mL each) 1 month apart.
There are no data available on the interchangeability of the Moderna COVID-19 Vaccine withother 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.
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 ofsevere 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 theModerna 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
Reports of adverse events following use of the Moderna COVID-19 Vaccine under EUA suggest
increased risks of myocarditis and pericarditis, particularly following the second dose. Typically,
onset of symptoms has been within a few days following receipt of the Moderna COVID-19
Vaccine. Available data from short-term follow-up suggest that most individuals have had
resolution of symptoms, but information is not yet available about potential long-term sequelae.
The decision to administer the Moderna COVID-19 Vaccine to an individual with a history of
myocarditis or pericarditis should take into account the individual’s clinical circumstances. The
CDC has published clinical considerations relevant to myocarditis and pericarditis associatedwith administration of the Moderna COVID-19 Vaccine (https://www.cdc.gov/vaccines/covid19/clinical-considerations/myocarditis.html).
Revised: Jun/24/2021

11

5.3 Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressive therapy, may
have a diminished response to the Moderna COVID-19 Vaccine.
5.4 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 andModernaTX, 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).
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, themean 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,
Revised: Jun/24/2021

12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 werecollected in an electronic diary for 7 days following each injection (i.e., day of vaccination andthe next 6 days) among participants receiving Moderna COVID-19 Vaccine (n=15,179) andparticipants 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)
Placeboa

Moderna COVID-19 Vaccine

Local Adverse
Reactions
Pain
Pain, Grade 3b
Axillaryswelling/tenderness
Axillaryswelling/tenderness,
Grade 3b
Swelling (hardness)≥25 mmSwelling (hardness),
Grade 3c
Erythema (redness)≥25 mmErythema (redness),
Grade 3c
Systemic Adverse
Reactions
Fatigue
Fatigue, Grade 3d
Fatigue, Grade 4e

Revised: Jun/24/2021

Dose 1(N=11,406)n (%)

Dose 2(N=10,985)n (%)

Dose 1(N=11,407)n (%)

Dose 2(N=10,918)
n (%)

9,908
(86.9)
366
(3.2)
1,322
(11.6)
37
(0.3)

9,873
(89.9)
506
(4.6)
1,775
(16.2)
46
(0.4)

2,177
(19.1)
23
(0.2)
567
(5.0)
13
(0.1)

2,040
(18.7)
22
(0.2)
470
(4.3)
11
(0.1)

767
(6.7)
62
(0.5)
344
(3.0)
34
(0.3)

1,389
(12.6)
182
(1.7)
982
(8.9)
210
(1.9)

34
(0.3)
3
(<0.1)
47(0.4)
11(<0.1)

36(0.3)
4(<0.1)
43
(0.4)
12
(0.1)

4,384
(38.4)
120(1.1)
1(<0.1)

7,430(67.6)
1,174(10.7)
0(0)3,282(28.8)
83
(0.7)
0
(0)

2,687
(24.6)
86
(0.8)
0
(0)

13

Placeboa

Moderna COVID-19 Vaccine

HeadacheHeadache, Grade 3f
Myalgia
Myalgia, Grade 3d
Arthralgia
Arthralgia, Grade 3d
Arthralgia, Grade 4e
ChillsChills, Grade 3g
Nausea/vomiting
Nausea/vomiting,
Grade 3hFever
Fever, Grade 3i
Fever, Grade 4j
Use of antipyretic or
pain medication

Dose 1(N=11,406)
n (%)
4,030
(35.3)
219
(1.9)
2,699
(23.7)
73
(0.6)
1,893
(16.6)
47(0.4)
1(<0.1)
1,051
(9.2)
17
(0.1)
1,068
(9.4)
6
(<0.1)
105(0.9)
10(<0.1)
4(<0.1)
2,656(23.3)

Dose 2(N=10,985)
n (%)
6,898
(62.8)
553
(5.0)
6,769
(61.6)
1,113(10.1)
4,993(45.5)
647
(5.9)
0
(0)
5,341
(48.6)
164
(1.5)
2,348
(21.4)
10(<0.1)
1,908(17.4)
184
(1.7)
12
(0.1)
6,292
(57.3)

Dose 1(N=11,407)
n (%)
3,304
(29.0)
162
(1.4)
1,628
(14.3)
38
(0.3)
1,327
(11.6)
29
(0.3)
0
(0)
730
(6.4)
8
(<0.1)
908(8.0)
8(<0.1)
37(0.3)
1(<0.1)
4(<0.1)
1,523(13.4)

Dose 2(N=10,918)
n (%)
2,760
(25.3)
129
(1.2)
1,411
(12.9)
42
(0.4)
1,172
(10.7)
37
(0.3)
0
(0)
658
(6.0)
15
(0.1)
801
(7.3)
8
(<0.1)
39(0.4)
2(<0.1)
2(<0.1)
1,248(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).
aPlacebo was a saline solution.
b
Grade 3 pain and axillary swelling/tenderness: Defined as any use of prescription pain reliever; prevents daily
activity.
cGrade 3 swelling and erythema: Defined as >100 mm / >10 cm.
d
Grade 3 fatigue, myalgia, arthralgia: Defined as significant; prevents daily activity.
eGrade 4 fatigue, arthralgia: Defined as requires emergency room visit or hospitalization.
fGrade 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.
hGrade 3 nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration.
iGrade 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.

Revised: Jun/24/2021

14

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)
Placeboa

Moderna COVID-19 Vaccine

Local Adverse
Reactions
Pain
Pain, Grade 3b
Axillaryswelling/tenderness
Axillaryswelling/tenderness,
Grade 3b
Swelling (hardness)≥25 mmSwelling (hardness),
Grade 3c
Erythema (redness)≥25 mmErythema (redness),
Grade 3c
Systemic Adverse
Reactions
Fatigue
Fatigue, Grade 3d
HeadacheHeadache, Grade 3e
Myalgia
Myalgia, Grade 3d
Arthralgia
Arthralgia, Grade 3d
ChillsChills, Grade 3f
Nausea/vomiting

Revised: Jun/24/2021

Dose 1(N=3,762)n (%)

Dose 2(N=3,692)n (%)

Dose 1(N=3,748)n (%)

Dose 2(N=3,648)
n (%)

2,782
(74.0)
50
(1.3)
231
(6.1)
12
(0.3)

3,070
(83.2)
98
(2.7)
315
(8.5)
21
(0.6)

481
(12.8)
32
(0.9)
155
(4.1)
14
(0.4)

437
(12.0)
18
(0.5)
97
(2.7)
8
(0.2)

165
(4.4)
20
(0.5)
86
(2.3)
8
(0.2)

400
(10.8)
72
(2.0)
275
(7.5)
77
(2.1)

18
(0.5)
3
(<0.1)
20(0.5)
2(<0.1)

13
(0.4)
7
(0.2)
13
(0.4)
3
(<0.1)

1,251(33.3)
30(0.8)
921(24.5)
52(1.4)
742(19.7)
17(0.5)
618(16.4)
13
(0.3)
202
(5.4)
7
(0.2)
194
(5.2)

2,152
(58.3)
254
(6.9)
1,704
(46.2)
106
(2.9)
1,739
(47.1)
205
(5.6)
1,291
(35.0)
123
(3.3)
1,141
(30.9)
27(0.7)
437(11.8)

851(22.7)
22(0.6)
723(19.3)
34(0.9)
443(11.8)
9(0.2)
456(12.2)
8
(0.2)
148
(4.0)
6
(0.2)
166
(4.4)

716
(19.6)
20(0.5)
650(17.8)
33(0.9)
398(10.9)
10(0.3)
397(10.9)
7
(0.2)
151
(4.1)
2
(<0.1)
133
(3.6)

15

Placeboa

Moderna COVID-19 Vaccine

Nausea/vomiting,
Grade 3g
Nausea/vomiting,
Grade 4h
Fever
Fever, Grade 3i
Fever, Grade 4j
Use of antipyretic or
pain medication

Dose 1(N=3,762)
n (%)
4
(0.1)
0
(0)
10
(0.3)
1
(<0.1)
0(0)673(17.9)

Dose 2(N=3,692)
n (%)
10
(0.3)
1
(<0.1)
370(10.0)
18(0.5)
1(<0.1)
1,546(41.9)

Dose 1(N=3,748)
n (%)
4
(0.1)
0
(0)
7
(0.2)
1
(<0.1)
2(<0.1)
477(12.7)

Dose 2(N=3,648)n (%)
3(<0.1)
0
(0)
4
(0.1)
0
(0)
1
(<0.1)
329(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).
aPlacebo was a saline solution.
b
Grade 3 pain and axillary swelling/tenderness: Defined as any use of prescription pain reliever; prevents daily
activity.
cGrade 3 swelling and erythema: Defined as >100 mm / >10 cm.
d
Grade 3 fatigue, myalgia, arthralgia: Defined as significant; prevents daily activity.
eGrade 3 headache: Defined as significant; any use of prescription pain reliever or prevents daily activity.
fGrade 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.
hGrade 4 Nausea/vomiting: Defined as requires emergency room visit or hospitalization for hypotensive shock.
iGrade 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 doseand follow-up is ongoing. Serious adverse events and medically attended adverse events will berecorded 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
by 23.9% of participants (n=3,632) who received Moderna COVID-19 Vaccine and 21.6% ofparticipants (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
Revised: Jun/24/2021

16

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 axillaryswelling/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 relationshipwith 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, andthrombotic 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 ofvaccine.
In these analyses, 87.9% of study participants had at least 28 days of follow-up after Dose 2, andthe 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 withprior 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 specificcategories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic
events) that would suggest a causal relationship to Moderna COVID-19 Vaccine.

Revised: Jun/24/2021

17

6.2 Post-Authorization Experience
The following adverse reactions have been identified during post-authorization use of theModerna 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
8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTSAND 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 tothe 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 theoutcomes 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 1-877721-0366. If you need additional help submitting a report, you may call the VAERS tollfree 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
Revised: Jun/24/2021

18

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 thetime of the VAERS report. Subsequent reporting of follow-up information should becompleted 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 thehealthcare provider’s office address).
Other Reporting Instructions
Vaccination providers may report to VAERS other adverse events that are not required to bereported 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.
EmailFax number

Telephone number

ModernaPV@modernatx.com

1-866-599-1342

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

Revised: Jun/24/2021

19

10 DRUG INTERACTIONSThere are no data to assess the concomitant administration of the Moderna COVID-19 Vaccinewith 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 toModerna 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 1-866MODERNA (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 clinicallyrecognized 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 vaccineassociated risks in pregnancy.
In a developmental toxicity study, 0.2 mL of a vaccine formulation containing the same quantityof 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
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 andRevised: Jun/24/2021

20

efficacy. In an ongoing Phase 3 clinical study, 24.8% (n=7,520) of participants were 65 years ofage 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 to95.6% (95% CI 90.6, 97.9) in participants 18 to <65 years of age [see Clinical Trial Results andSupporting 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)].
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 nucleosidemodified 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.
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 tosevere 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
Revised: Jun/24/202121requiring significant change in therapy or hospitalization for worsening disease during the 3months 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 theModerna 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 PerProtocol 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 atleast 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 notabledifferences 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, sorethroat, new olfactory and taste disorder(s); or the participant must have experienced at least oneof the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing,or clinical or radiographical evidence of pneumonia; and the participant must have at least one
NP swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARSCoV-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% to96.8%).

Revised: Jun/24/2021

22

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
COVID-19
Participants
Incidence
Cases(N)
Rate of(n)
COVID-19
per 1,000
PersonYears
14,13411
3.328

Participants(N)

Placebo
COVID-19
Cases(n)

14,073

185

Incidence
Rate of
COVID-19
per 1,000
PersonYears
56.510% Vaccine
Efficacy(95% CI)†

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
Age
Subgroup(Years)18 to <65
≥65

Moderna COVID-19 Vaccine
Participants COVID-19 Incidence
Cases
(N)
Rate of(n)
COVID-19
per 1,000
PersonYears
10,551
7
2.875
3,583

4

4.595

Participants(N)

Placebo
COVID-19
Cases(n)

10,521

156

Incidence
Rate of
COVID-19
per 1,000
PersonYears
64.6253,552

29

33.728%
VaccineEfficacy
(95%
CI)*
95.6
(90.6, 97.9)
86.4(61.4, 95.2)* COVID-19: symptomatic COVID-19 requiring positive RT-PCR result and at least two systemic symptoms or one
respiratory symptom. Cases starting 14 days after Dose 2.
† VE and 95% CI from the stratified Cox proportional hazard model.

Severe COVID-19 was defined based on confirmed COVID-19 as per the primary efficacy
endpoint case definition, plus any of the following: Clinical signs indicative of severe systemic
illness, respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, SpO2 ≤93% on room
air at sea level or PaO2/FIO2 <300 mm Hg; or respiratory failure or ARDS (defined as needinghigh-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
Revised: Jun/24/202123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.
19 HOW SUPPLIED/STORAGE AND HANDLING
Moderna COVID-19 Vaccine Suspension for Intramuscular Injection Multiple-Dose Vials aresupplied 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 temperaturescolder 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 firstuse. 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° to77°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°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 underroutine road and air transport conditions with shaking and vibration minimized. Once thawed andtransported 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.

Revised: Jun/24/2021

24

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 caregiverthat 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 resent 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: Jun/24/2021

Revised: Jun/24/2021

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