Moderna COVID-19 Vaccine: Package Insert and Label Information (Page 2 of 5)

ADDITIONAL INFORMATION

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

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

Website

Telephone number

www.modernatx.com/covid19vaccine-eua

Moderna QR code

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

AVAILABLE ALTERNATIVES

Comirnaty (COVID-19 Vaccine, mRNA) is an FDA-approved vaccine to prevent COVID-19 caused by SARS-CoV-2. There may be clinical trials or availability under EUA of other COVID-19 vaccines.

FEDERAL COVID-19 VACCINATION PROGRAM

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

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

AUTHORITY FOR ISSUANCE OF THE EUA

The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 Pandemic. In response, the FDA has issued an EUA for the unapproved product, Moderna COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 18 years of age and older.

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

Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Moderna COVID-19 Vaccine may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information.

This EUA for the Moderna COVID-19 Vaccine will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.

For additional information about Emergency Use Authorization, visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy- framework/emergency-use-authorization.

COUNTERMEASURES INJURY COMPENSATION PROGRAM

The Countermeasures Injury Compensation Program (CICP) is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. For more information about CICP regarding the vaccines to prevent COVID-19, visit http://www.hrsa.gov/cicp, email cicp@hrsa.gov, or call: 1-855-266-2427.

Moderna US, Inc.
Cambridge, MA 02139

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

END SHORT VERSION FACT SHEET

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

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION MODERNA COVID-19 VACCINE

FULL EUA PRESCRIBING INFORMATION: CONTENTS*

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

1 AUTHORIZED USE

10 DRUG INTERACTIONS

2 DOSAGE AND ADMINISTRATION

11 USE IN SPECIFIC POPULATIONS

2.1 Preparation for Administration

11.1 Pregnancy

2.2 Administration

11.2 Lactation

2.3 Dosing and Schedule

11.3 Pediatric Use

3 DOSAGE FORMS AND STRENGTHS

11.4 Geriatric Use

4 CONTRAINDICATIONS

11.5 Use in Immunocompromised

5 WARNINGS AND PRECAUTIONS

13 DESCRIPTION

5.1 Management of Acute Allergic Reactions

14 CLINICAL PHARMACOLOGY

5.2 Myocarditis and Pericarditis

14.1 Mechanism of Action

5.3 Syncope

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

5.4 Altered Immunocompetence

19 HOW SUPPLIED/STORAGE AND HANDLING

5.5 Limitations of Vaccine Effectiveness

20 PATIENT COUNSELING INFORMATION

6 OVERALL SAFETY SUMMARY

21 CONTACT INFORMATION

6.1 Clinical Trials Experience

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

6.2 Post-Authorization Experience

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.

Vial

Thaw in Refrigerator

Thaw at Room Temperature

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.

Alternatively, thaw at room temperature between 15° to 25°C for 1 hour.

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

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

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 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:
    • A multiple-dose vial containing a maximum of 11 doses: range 10-11 doses (0.5 mL each).
    • 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:
    • Each dose must contain 0.5 mL of vaccine.
    • 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.
    • 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.

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 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).

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 Placebo a
Dose 1 (N=11,406) n (%) Dose 2 (N=10,985) n (%) Dose 1 (N=11,407) n (%) Dose 2 (N=10,918) n (%)
* 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. 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.

Local Adverse Reactions

Pain

9,908

(86.9)

9,873

(89.9)

2,177

(19.1)

2,040

(18.7)

Pain, Grade 3 b

366

(3.2)

506

(4.6)

23

(0.2)

22

(0.2)

Axillary swelling/tenderness

1,322

(11.6)

1,775

(16.2)

567

(5.0)

470

(4.3)

Axillary swelling/tenderness, Grade 3 b

37

(0.3)

46

(0.4)

13

(0.1)

11

(0.1)

Swelling (hardness)

≥25 mm

767

(6.7)

1,389

(12.6)

34

(0.3)

36

(0.3)

Swelling (hardness), Grade 3 c

62

(0.5)

182

(1.7)

3

(<0.1)

4

(<0.1)

Erythema (redness)

≥25 mm

344

(3.0)

982

(8.9)

47

(0.4)

43

(0.4)

Erythema (redness), Grade 3 c

34

(0.3)

210

(1.9)

11

(<0.1)

12

(0.1)

Systemic Adverse Reactions

Fatigue

4,384

(38.4)

7,430

(67.6)

3,282

(28.8)

2,687

(24.6)

Fatigue, Grade 3 d

120

(1.1)

1,174

(10.7)

83

(0.7)

86

(0.8)

Fatigue, Grade 4 e

1

(<0.1)

0

(0)

0

(0)

0

(0)

Headache

4,030

(35.3)

6,898

(62.8)

3,304

(29.0)

2,760

(25.3)

Headache, Grade 3 f

219

(1.9)

553

(5.0)

162

(1.4)

129

(1.2)

Myalgia

2,699

(23.7)

6,769

(61.6)

1,628

(14.3)

1,411

(12.9)

Myalgia, Grade 3 d

73

(0.6)

1,113

(10.1)

38

(0.3)

42

(0.4)

Arthralgia

1,893

(16.6)

4,993

(45.5)

1,327

(11.6)

1,172

(10.7)

Arthralgia, Grade 3 d

47

(0.4)

647

(5.9)

29

(0.3)

37

(0.3)

Arthralgia, Grade 4 e

1

(<0.1)

0

(0)

0

(0)

0

(0)

Chills

1,051

(9.2)

5,341

(48.6)

730

(6.4)

658

(6.0)

Chills, Grade 3 g

17

(0.1)

164

(1.5)

8

(<0.1)

15

(0.1)

Nausea/vomiting

1,068

(9.4)

2,348

(21.4)

908

(8.0)

801

(7.3)

Nausea/vomiting,

Grade 3 h

6

(<0.1)

10

(<0.1)

8

(<0.1)

8

(<0.1)

Fever

105

(0.9)

1,908

(17.4)

37

(0.3)

39

(0.4)

Fever, Grade 3 i

10

(<0.1)

184

(1.7)

1

(<0.1)

2

(<0.1)

Fever, Grade 4 j

4

(<0.1)

12

(0.1)

4

(<0.1)

2

(<0.1)

Use of antipyretic or pain medication

2,656

(23.3)

6,292

(57.3)

1,523

(13.4)

1,248

(11.4)

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 Placebo a
Dose 1 (N=3,762) n (%) Dose 2 (N=3,692) n (%) Dose 1 (N=3,748) n (%) Dose 2 (N=3,648) n (%)
* 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.

Local Adverse Reactions

Pain

2,782

(74.0)

3,070

(83.2)

481

(12.8)

437

(12.0)

Pain, Grade 3 b

50

(1.3)

98

(2.7)

32

(0.9)

18

(0.5)

Axillary swelling/tenderness

231

(6.1)

315

(8.5)

155

(4.1)

97

(2.7)

Axillary swelling/tenderness, Grade 3 b

12

(0.3)

21

(0.6)

14

(0.4)

8

(0.2)

Swelling (hardness)

≥25 mm

165

(4.4)

400

(10.8)

18

(0.5)

13

(0.4)

Swelling (hardness), Grade 3 c

20

(0.5)

72

(2.0)

3

(<0.1)

7

(0.2)

Erythema (redness)

≥25 mm

86

(2.3)

275

(7.5)

20

(0.5)

13

(0.4)

Erythema (redness), Grade 3 c

8

(0.2)

77

(2.1)

2

(<0.1)

3

(<0.1)

Systemic Adverse Reactions

Fatigue

1,251

(33.3)

2,152

(58.3)

851

(22.7)

716

(19.6)

Fatigue, Grade 3 d

30

(0.8)

254

(6.9)

22

(0.6)

20

(0.5)

Headache

921

(24.5)

1,704

(46.2)

723

(19.3)

650

(17.8)

Headache, Grade 3 e

52

(1.4)

106

(2.9)

34

(0.9)

33

(0.9)

Myalgia

742

(19.7)

1,739

(47.1)

443

(11.8)

398

(10.9)

Myalgia, Grade 3 d

17

(0.5)

205

(5.6)

9

(0.2)

10

(0.3)

Arthralgia

618

(16.4)

1,291

(35.0)

456

(12.2)

397

(10.9)

Arthralgia, Grade 3 d

13

(0.3)

123

(3.3)

8

(0.2)

7

(0.2)

Chills

202

(5.4)

1,141

(30.9)

148

(4.0)

151

(4.1)

Chills, Grade 3 f

7

(0.2)

27

(0.7)

6

(0.2)

2

(<0.1)

Nausea/vomiting

194

(5.2)

437

(11.8)

166

(4.4)

133

(3.6)

Nausea/vomiting,

Grade 3 g

4

(0.1)

10

(0.3)

4

(0.1)

3

(<0.1)

Nausea/vomiting,

Grade 4 h

0

(0)

1

(<0.1)

0

(0)

0

(0)

Fever

10

(0.3)

370

(10.0)

7

(0.2)

4

(0.1)

Fever, Grade 3 i

1

(<0.1)

18

(0.5)

1

(<0.1)

0

(0)

Fever, Grade 4 j

0

(0)

1

(<0.1)

2

(<0.1)

1

(<0.1)

Use of antipyretic or pain medication

673

(17.9)

1,546

(41.9)

477

(12.7)

329

(9.0)

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 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.

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.

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