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Clinical Trial Results:
A Randomized, Observer-blind, Active-controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283 Compared With mRNA-1273 in Participants Aged ≥12 Years for the Prevention of COVID-19

Summary
EudraCT number	2023-000884-30
Trial protocol	Outside EU/EEA
Global end of trial date	12 Apr 2025

Results information
Results version number	v1(current)
This version publication date	26 Oct 2025
First version publication date	26 Oct 2025
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

mRNA-1283-P301

ISRCTN number

US NCT number

NCT05815498

WHO universal trial number (UTN)

Sponsor organisation name

ModernaTX, Inc.

Sponsor organisation address

325 Binney Street, Cambridge, United States, 02142

Public contact

Moderna WeCare Team, ModernaTX, Inc., +1 866-663-3762, WeCareClinicalTrials@modernatx.com

Scientific contact

Moderna WeCare Team, ModernaTX, Inc., +1 866-663-3762, WeCareClinicalTrials@modernatx.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-003426-PIP01-23

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

25 Jun 2025

Is this the analysis of the primary completion data?

Yes

Primary completion date

12 Apr 2025

Global end of trial reached?

Yes

Global end of trial date

12 Apr 2025

Was the trial ended prematurely?

Main objective of the trial

The primary objectives of this study were: • To demonstrate a non-inferior neutralizing antibody (nAb) response of mRNA-1283.222 compared to mRNA-1273.222 against Omicron BA.4/5 and ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G based on geometric mean ratio (GMR) and seroresponse rate (SRR) difference at Day 29. • To demonstrate non-inferior relative vaccine efficacy (rVE) of mRNA-1283 compared to mRNA-1273 (variant formulations) to prevent COVID 19. • To evaluate the safety and reactogenicity of mRNA-1283.222.

Protection of trial subjects

This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences, International Ethical Guidelines, applicable International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines, and other applicable laws and regulations.

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Mar 2023

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 8634

Country: Number of subjects enrolled

Canada: 213

Country: Number of subjects enrolled

United Kingdom: 2569

Worldwide total number of subjects

11416

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

992

Adults (18-64 years)

7150

From 65 to 84 years

3227

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 11453 participants were randomized, and 11416 participants were dosed, of which 5706 participants were in the mRNA-1283.222 group and 5710 participants were in the mRNA-1273.222 group.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Carer, Assessor, Subject

Are arms mutually exclusive

Yes

mRNA-1283.222

Arm description

Participants received a single intramuscular (IM) injection of mRNA-1283.222 on Day 1.

Arm type

Experimental

Investigational medicinal product name

mRNA-1283.222

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

mRNA-1283.222 was administered per schedule specified in the arm description.

mRNA-1273.222

Arm description

Participants received a single IM injection of mRNA-1273.222 on Day 1.

Arm type

Active comparator

Investigational medicinal product name

mRNA-1273.222

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

mRNA-1273.222 was administered per schedule specified in the arm description.

Number of subjects in period 1	mRNA-1283.222	mRNA-1273.222
Started	5706	5710
Completed	5312	5373
Not completed	394	337
Adverse event, serious fatal	7	11
Physician decision	14	10
Consent withdrawn by subject	181	157
Other Than Specified	4	4
Adverse event, non-fatal	4	2
Pregnancy	2	-
Lost to follow-up	180	152
Protocol deviation	2	1

Baseline characteristics

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Reporting group title

mRNA-1283.222

Reporting group description

Participants received a single intramuscular (IM) injection of mRNA-1283.222 on Day 1.

Reporting group title

mRNA-1273.222

Reporting group description

Participants received a single IM injection of mRNA-1273.222 on Day 1.

Reporting group values	mRNA-1283.222	mRNA-1273.222	Total
Number of subjects	5706	5710	11416
Age Categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	51.1 ( 18.58 )	51.2 ( 18.32 )	-
Gender Categorical
Units: Subjects
Female	3120	3079	6199
Male	2586	2631	5217
Race
Units: Subjects
White	4670	4711	9381
Black or African American	640	634	1274
Asian	225	183	408
American Indian or Alaska Native	20	26	46
Native Hawaiian or Other Pacific Islander	9	6	15
Multiple	81	94	175
Other	20	20	40
Not Reported	36	26	62
Unknown	5	10	15
Ethnicity
Units: Subjects
Hispanic or Latino	769	741	1510
Not Hispanic or Latino	4860	4863	9723
Not Reported	59	87	146
Unknown	18	19	37

End points

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Reporting group title

mRNA-1283.222

Reporting group description

Participants received a single intramuscular (IM) injection of mRNA-1283.222 on Day 1.

Reporting group title

mRNA-1273.222

Reporting group description

Participants received a single IM injection of mRNA-1273.222 on Day 1.

Primary: Geometric Mean (GM) of Omicron BA.4/5 at Day 29

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End point title

Geometric Mean (GM) of Omicron BA.4/5 at Day 29

End point description

Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. LLOQ was 103 arbitrary units (AU)/milliliter (mL) and ULOQ was 28571 AU/mL. Per-Protocol Immunogenicity Set (PPIS) included all randomized participants who received the planned dose of study vaccination, had baseline and Day 29 nAb data, and had no major protocol deviations that impacted key or critical data.

End point type

Primary

End point timeframe

Day 29

End point values	mRNA-1283.222	mRNA-1273.222
Number of subjects analysed	621	568
Units: AU/mL
geometric mean (confidence interval 95%)	2340.9 (2167.0 to 2528.8)	1753.8 (1618.2 to 1900.7)

Statistical Analysis 1

Statistical analysis description

Geometric mean ratio (GMR) of Omicron BA.4/5 mRNA-1283.222 over the Omicron BA.4/5 mRNA-1273.222 was the primary endpoint.

Comparison groups

mRNA-1283.222 v mRNA-1273.222

Number of subjects included in analysis

1189

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[1]

Method

Parameter type

GMR

Point estimate

1.335

Confidence interval

level

95%

sides

2-sided

lower limit

1.194

upper limit

1.492

Notes
[1] - Noninferiority margin for GMR was 0.667 (1/1.5).

Primary: Seroresponse Rate (SRR) Omicron BA.4/5 at Day 29

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End point title

Seroresponse Rate (SRR) Omicron BA.4/5 at Day 29

End point description

Seroresponse was defined as an antibody value change from baseline below the LLOQ to ≥4*LLOQ, or at least a 4-fold rise if baseline was ≥LLOQ and <4*LLOQ, or at least a 2-fold rise if baseline was ≥4*LLOQ, where baseline referred to pre-booster. LLOQ was 103 AU/mL and ULOQ was 28571 AU/mL. PPIS included all randomized participants who received the planned dose of study vaccination, had baseline and Day 29 (occurring between 21 and 42 days after vaccination) nAb data, and had no major protocol deviations that impacted key or critical data.

End point type

Primary

End point timeframe

Day 29

End point values	mRNA-1283.222	mRNA-1273.222
Number of subjects analysed	621	568
Units: percentage of participants
number (confidence interval 95%)	79.9 (76.5 to 83.0)	65.5 (61.4 to 69.4)

Statistical Analysis 1

Statistical analysis description

SRR difference of Omicron BA.4/5 between mRNA-1283.222 and mRNA-1273.222 was the primary endpoint.

Comparison groups

mRNA-1283.222 v mRNA-1273.222

Number of subjects included in analysis

1189

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[2]

Method

Parameter type

SRR Difference

Point estimate

14.4

Confidence interval

level

95%

sides

2-sided

lower limit

9.3

upper limit

19.4

Notes
[2] - Noninferiority margin for SRR difference was 10%.

Primary: GM of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G at Day 29

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End point title

GM of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G at Day 29

End point description

Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PPIS included all randomized participants who received the planned dose of study vaccination, had baseline and Day 29 nAb data, and had no major protocol deviations that impacted key or critical data.

End point type

Primary

End point timeframe

Day 29

End point values	mRNA-1283.222	mRNA-1273.222
Number of subjects analysed	621	568
Units: AU/mL
geometric mean (confidence interval 95%)	10631.9 (9960.2 to 11348.9)	8576.5 (8012.5 to 9180.1)

Statistical Analysis 1

Statistical analysis description

GMR of the ancestral SARS-CoV-2 D614G mRNA-1283.222 over the ancestral SARS-CoV-2 D614G mRNA-1273.222 was the primary endpoint.

Comparison groups

mRNA-1283.222 v mRNA-1273.222

Number of subjects included in analysis

1189

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[3]

Method

Parameter type

GMR

Point estimate

1.24

Confidence interval

level

95%

sides

2-sided

lower limit

1.128

upper limit

1.362

Notes
[3] - Noninferiority margin for GMR was 0.667 (1/1.5).

Primary: SRR of Ancestral SARS-CoV-2 D641G at Day 29

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End point title

SRR of Ancestral SARS-CoV-2 D641G at Day 29

End point description

End point type

Primary

End point timeframe

Day 29

End point values	mRNA-1283.222	mRNA-1273.222
Number of subjects analysed	621	568
Units: percentage of participants
number (confidence interval 95%)	83.6 (80.4 to 86.4)	72.9 (69.0 to 76.5)

Statistical Analysis 1

Statistical analysis description

SRR difference of ancestral SARS-CoV-2 D641G between mRNA-1283.222 and mRNA-1273.222 was the primary endpoint.

Comparison groups

mRNA-1283.222 v mRNA-1273.222

Number of subjects included in analysis

1189

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[4]

Method

Parameter type

SRR Difference

Point estimate

10.7

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

15.4

Notes
[4] - Noninferiority margin for SRR difference was 10%.

Primary: Number of Participants With First Event of Centers for Disease Control and Prevention (CDC)-defined COVID-19

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End point title

Number of Participants With First Event of Centers for Disease Control and Prevention (CDC)-defined COVID-19

End point description

CDC COVID-19 definition: the presence of at least 1 CDC listed symptom and positive reverse transcriptase polymerase chain reaction (RT-PCR) test on a respiratory sample. The Per-Protocol Set for Efficacy (PPSE) included all randomized participants who received the planned dose of study drug and had no major protocol deviations that impacted vaccine efficacy data.

End point type

Primary

End point timeframe

From 14 days after injection up to Day 365

End point values	mRNA-1283.222	mRNA-1273.222
Number of subjects analysed	5679	5687
Units: participants	560	617

Statistical Analysis 1

Statistical analysis description

Relative vaccine efficacy (rVE) of mRNA-1283 and mRNA-1273 (variant formulations) to prevent the first event of CDC-defined COVID-19 was the primary endpoint. rVE was defined as 1 - hazard ratio (mRNA-1283.222 versus mRNA-1273.222).

Comparison groups

mRNA-1283.222 v mRNA-1273.222

Number of subjects included in analysis

11366

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[5]

P-value

= 0.0005

Method

Cox proportional hazard model

Parameter type

rVE

Point estimate

9.31

Confidence interval

level

99.4%

sides

2-sided

lower limit

-6.58

upper limit

22.83

Notes
[5] - Noninferiority margin for rVE was 10%.

Primary: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

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End point title

Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) ^[6]

End point description

Solicited ARs were recorded daily using electronic diaries (eDiaries). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. The Solicited Safety Set included all randomized participants who received study drug and contributed any solicited AR data.

End point type

Primary

End point timeframe

Up to Day 7 (7-day follow-up after vaccination)

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The endpoint is descriptive in nature.

End point values	mRNA-1283.222	mRNA-1273.222
Number of subjects analysed	5702	5705
Units: participants	4571	4781

No statistical analyses for this end point

Primary: Number of Participants with Unsolicited Adverse Events (AEs)

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End point title

Number of Participants with Unsolicited Adverse Events (AEs) ^[7]

End point description

An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the ‘Reported Adverse Events’ Section. The Safety Set included all randomized participants who received study drug.

End point type

Primary

End point timeframe

Up to Day 28 (28-day follow-up after vaccination)

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The endpoint is descriptive in nature.

End point values	mRNA-1283.222	mRNA-1273.222
Number of subjects analysed	5706	5710
Units: participants	706	683

No statistical analyses for this end point

Primary: Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs)

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End point title

Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs) ^[8]

End point description

SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. MAAEs were AEs that lead to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor’s product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the ‘Reported Adverse Events’ Section. The Safety Set included all randomized participants who received study drug.

End point type

Primary

End point timeframe

Day 1 up to Day 365

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The endpoint is descriptive in nature.

End point values	mRNA-1283.222	mRNA-1273.222
Number of subjects analysed	5706	5710
Units: participants
SAEs	203	197
MAAEs	2165	2120
AEs Leading to Withdrawal From Study	11	13
AESIs	79	75

No statistical analyses for this end point

Secondary: GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G

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End point title

GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G

End point description

Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 103 AU/mL and ULOQ was 28571 AU/mL for Omicron BA.4/5. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for ancestral SARS-CoV-2 D614G. PPIS included all randomized participants who received the planned dose of study vaccination, had baseline and Day 29 nAb data, and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable for specified category.

End point type

Secondary

End point timeframe

Days 91, 181, and 365

End point values	mRNA-1283.222	mRNA-1273.222
Number of subjects analysed	605	552
Units: AU/mL
geometric mean (confidence interval 95%)
Omicron BA.4/5: Day 91 (n=605,552)	1513.2 (1400.9 to 1634.5)	1137.8 (1049.8 to 1233.3)
Omicron BA.4/5: Day 181 (n=541,520)	1113.3 (1022.4 to 1212.3)	863.7 (792.1 to 941.9)
Omicron BA.4/5: Day 365 (n=506,488)	753.3 (690.2 to 822.2)	625.9 (572.8 to 684.0)
SARS-CoV-2 D614G: Day 91 (n=605,552)	6537.7 (6086.0 to 7023.0)	5414.0 (5023.9 to 5834.3)
SARS-CoV-2 D614G: Day 181 (n=540,520)	4753.2 (4381.5 to 5156.5)	3861.8 (3555.3 to 4194.6)
SARS-CoV-2 D614G: Day 365 (n=506,488)	2878.9 (2645.2 to 3133.3)	2545.0 (2335.6 to 2773.2)

No statistical analyses for this end point

Secondary: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G at Days 91, 181, and 365

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End point title

SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G at Days 91, 181, and 365

End point description

Seroresponse was defined as an antibody value change from baseline below the LLOQ to ≥4*LLOQ, or at least a 4-fold rise if baseline was ≥LLOQ and <4*LLOQ, or at least a 2-fold rise if baseline was ≥4*LLOQ, where baseline referred to pre-booster. LLOQ was 103 AU/mL and ULOQ was 28571 AU/mL for Omicron BA.4/5. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for ancestral SARS-CoV-2 D614G. PPIS included all randomized participants who received the planned dose of study vaccination, had baseline and Day 29 nAb data, and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable for specified category.

End point type

Secondary

End point timeframe

Days 91, 181, and 365

End point values	mRNA-1283.222	mRNA-1273.222
Number of subjects analysed	605	552
Units: percentage of participants
number (confidence interval 95%)
Omicron BA.4/5: Day 91 (n=605,552)	59.5 (55.5 to 63.4)	45.8 (41.6 to 50.1)
Omicron BA.4/5: Day 181 (n=541,520)	45.7 (41.4 to 50.0)	37.1 (33.0 to 41.4)
Omicron BA.4/5: Day 365 (n=506,488)	30.0 (26.1 to 34.2)	26.4 (22.6 to 30.6)
SARS-CoV-2 D614G Day 91 (n=605,552)	64.8 (60.8 to 68.6)	52.9 (48.6 to 57.1)
SARS-CoV-2 D614G Day 181 (n=540,520)	45.6 (41.3 to 49.9)	39.0 (34.8 to 43.4)
SARS-CoV-2 D614G Day 365 (n=506,488)	26.3 (22.5 to 30.4)	25.4 (21.6 to 29.5)

No statistical analyses for this end point

Secondary: Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)

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End point title

Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)

End point description

SARS-CoV-2 infection (symptomatic or asymptomatic) was defined as (1) negative binding antibody (bAb) level against SARS-CoV-2 nucleocapsid protein and negative RT-PCR at baseline that became positive bAb level against SARS-CoV-2 nucleocapsid protein post-baseline, or (2) positive RT-PCR post-baseline. Asymptomatic SARS-CoV-2 infection was characterized by the absence of COVID-19 symptoms. The PPSE included all randomized participants who received the planned dose of study drug and had no major protocol deviations that impacted vaccine efficacy data. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

From 14 days after injection up to Day 365

End point values	mRNA-1283.222	mRNA-1273.222
Number of subjects analysed	5676	5684
Units: participants	1249	1290

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Day 1 up to Day 365

Adverse event reporting additional description

The Safety Set included all randomized participants who received study drug. 'Subject Disposition module' reported the number of participants who discontinued from the study due to death. 'Adverse Events module' reported "Total number of Deaths (all causes)".

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.1

Reporting group title

mRNA-1273.222

Reporting group description

Participants received a single IM injection of mRNA-1273.222 on Day 1.

Reporting group title

mRNA-1283.222

Reporting group description

Participants received a single IM injection of mRNA-1283.222 on Day 1.

Serious adverse events	mRNA-1273.222	mRNA-1283.222
Total subjects affected by serious adverse events
subjects affected / exposed	197 / 5710 (3.45%)	203 / 5706 (3.56%)
number of deaths (all causes)	11	9
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma pancreas
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	2 / 5710 (0.04%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic myeloid leukaemia
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer recurrent
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	2 / 5710 (0.04%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	0 / 5710 (0.00%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	0 / 5710 (0.00%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Adenoma benign
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Follicular lymphoma
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer stage III
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung carcinoma cell type unspecified stage IV
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal cancer
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive breast carcinoma
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal proliferative breast lesion
subjects affected / exposed	1 / 5710 (0.02%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	2 / 5710 (0.04%)	3 / 5706 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm malignant
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic malignant melanoma
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Oesophageal carcinoma
subjects affected / exposed	2 / 5710 (0.04%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Ovarian cancer
subjects affected / exposed	0 / 5710 (0.00%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer stage II
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma stage I
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma stage IV
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polycythaemia vera
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic gastric cancer
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	2 / 5710 (0.04%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	4 / 5710 (0.07%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma benign
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the tongue
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular germ cell cancer
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid cancer
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Orthostatic hypotension
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive urgency
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extremity necrosis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Deep vein thrombosis
subjects affected / exposed	3 / 5710 (0.05%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Superficial vein thrombosis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	1 / 5710 (0.02%)	3 / 5706 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Chills
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	0 / 5710 (0.00%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral swelling
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Death
Additional description: Arm mRNA-1273.222: >70 year-old participant with significant cardiovascular disease; cause of death at Day 7 was reported as unknown and related to vaccine by PI due to temporality. Sponsor assessed this and all other fatal events as unrelated.
subjects affected / exposed	2 / 5710 (0.04%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	1 / 2	0 / 2
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	1 / 5710 (0.02%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Ovarian cyst
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Hypoxia
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystic lung disease
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Combined pulmonary fibrosis and emphysema
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	2 / 5710 (0.04%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma
subjects affected / exposed	1 / 5710 (0.02%)	5 / 5706 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1
Pleural effusion
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	3 / 5710 (0.05%)	5 / 5706 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumothorax spontaneous
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	3 / 5710 (0.05%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	2 / 5710 (0.04%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Anxiety
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholism
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post-traumatic stress disorder
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Insomnia
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Depression suicidal
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	0 / 5710 (0.00%)	3 / 5706 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal behaviour
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	3 / 5710 (0.05%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Ankle fracture
subjects affected / exposed	2 / 5710 (0.04%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	0 / 5710 (0.00%)	3 / 5706 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Craniofacial fracture
subjects affected / exposed	1 / 5710 (0.02%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	0 / 5710 (0.00%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	2 / 5710 (0.04%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periprosthetic fracture
subjects affected / exposed	1 / 5710 (0.02%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle injury
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Overdose
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	2 / 5710 (0.04%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intentional overdose
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematoma
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	1 / 5710 (0.02%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	0 / 5710 (0.00%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Traumatic arthritis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic intracranial haemorrhage
subjects affected / exposed	0 / 5710 (0.00%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic fracture
subjects affected / exposed	1 / 5710 (0.02%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Urachal abnormality
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertrophic cardiomyopathy
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute left ventricular failure
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	3 / 5710 (0.05%)	3 / 5706 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	4 / 5710 (0.07%)	3 / 5706 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Acute coronary syndrome
subjects affected / exposed	2 / 5710 (0.04%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	7 / 5710 (0.12%)	4 / 5706 (0.07%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block first degree
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	2 / 5710 (0.04%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	1 / 5710 (0.02%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 2
Cardiac failure congestive
subjects affected / exposed	2 / 5710 (0.04%)	4 / 5706 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Coronary artery occlusion
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive heart disease
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Tachycardia
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial haemorrhage
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	6 / 5710 (0.11%)	7 / 5706 (0.12%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 1	0 / 1
Pericarditis
Additional description: In arm mRNA-1283.222, a participant of >50 year-old, the event was reported at Day 343 after vaccination as not related to vaccination by the Principal investigator (PI).
subjects affected / exposed	1 / 5710 (0.02%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Amyotrophic lateral sclerosis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bell's palsy
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	3 / 5710 (0.05%)	3 / 5706 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Cervical radiculopathy
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiplegia
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	2 / 5710 (0.04%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	3 / 5710 (0.05%)	5 / 5706 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	1 / 5710 (0.02%)	4 / 5706 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Speech disorder
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postictal paralysis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Posterior reversible encephalopathy syndrome
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	2 / 5710 (0.04%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve compression
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	2 / 5710 (0.04%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Blood loss anaemia
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	1 / 5710 (0.02%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo positional
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	2 / 5710 (0.04%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Retinal tear
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal hernia obstructive
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal mass
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall haematoma
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	2 / 5710 (0.04%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gastroparesis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eosinophilic oesophagitis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	3 / 5710 (0.05%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Hiatus hernia strangulated
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	1 / 5710 (0.02%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 5710 (0.00%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated inguinal hernia
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	2 / 5710 (0.04%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia, obstructive
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis chronic
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	2 / 5710 (0.04%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 5710 (0.00%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer perforation
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haematoma
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	1 / 5710 (0.02%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	1 / 5710 (0.02%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	2 / 5710 (0.04%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Gallbladder rupture
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	3 / 5710 (0.05%)	3 / 5706 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary obstruction
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute hepatic failure
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis alcoholic
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic mass
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Renal failure
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute kidney injury
subjects affected / exposed	2 / 5710 (0.04%)	6 / 5706 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Pituitary enlargement
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute aseptic arthritis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Compartment syndrome
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint effusion
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	6 / 5710 (0.11%)	10 / 5706 (0.18%)
occurrences causally related to treatment / all	0 / 6	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oligoarthritis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myopathy
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Arthritis bacterial
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	0 / 5710 (0.00%)	4 / 5706 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial food poisoning
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	4 / 5710 (0.07%)	3 / 5706 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 5710 (0.00%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bordetella infection
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coccidioidomycosis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	5 / 5710 (0.09%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural abscess
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia bacteraemia
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Groin abscess
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	1 / 5710 (0.02%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infected bite
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningoencephalitis viral
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	4 / 5710 (0.07%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	11 / 5710 (0.19%)	6 / 5706 (0.11%)
occurrences causally related to treatment / all	0 / 11	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psoas abscess
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative abscess
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	3 / 5710 (0.05%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary sepsis
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 5710 (0.02%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal sepsis
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	0 / 5710 (0.00%)	4 / 5706 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	2 / 5710 (0.04%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection viral
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 5710 (0.00%)	2 / 5706 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	0 / 5710 (0.00%)	3 / 5706 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Electrolyte imbalance
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	3 / 5710 (0.05%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	2 / 5710 (0.04%)	3 / 5706 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	1 / 5710 (0.02%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	1 / 5710 (0.02%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	1 / 5710 (0.02%)	0 / 5706 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Hypomagnesaemia
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	0 / 5710 (0.00%)	1 / 5706 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	mRNA-1273.222	mRNA-1283.222
Total subjects affected by non serious adverse events
subjects affected / exposed	636 / 5710 (11.14%)	607 / 5706 (10.64%)
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	636 / 5710 (11.14%)	607 / 5706 (10.64%)
occurrences all number	820	813

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Were there any global substantial amendments to the protocol? Yes

02 May 2023

This amendment introduced the primary rVE objective (noninferior efficacy of mRNA-1283 versus mRNA-1273) with a sample size increase up to 10748 participants. rVE was a key secondary study objective in the original study protocol.

08 Aug 2023

This amendment introduced a sample size increase specifically for the adolescent group, to enroll approximately 1000 adolescents.

20 Dec 2023

This amendment prespecified a noninferiority rVE margin of 10% (mRNA-1283 versus mRNA-1273) for the primary rVE objective.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Randomized, Observer-blind, Active-controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283 Compared With mRNA-1273 in Participants Aged ≥12 Years for the Prevention of COVID-19

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Geometric Mean (GM) of Omicron BA.4/5 at Day 29

Primary: Geometric Mean (GM) of Omicron BA.4/5 at Day 29

Primary: Seroresponse Rate (SRR) Omicron BA.4/5 at Day 29

Primary: Seroresponse Rate (SRR) Omicron BA.4/5 at Day 29

Primary: GM of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G at Day 29

Primary: GM of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G at Day 29

Primary: SRR of Ancestral SARS-CoV-2 D641G at Day 29

Primary: SRR of Ancestral SARS-CoV-2 D641G at Day 29

Primary: Number of Participants With First Event of Centers for Disease Control and Prevention (CDC)-defined COVID-19

Primary: Number of Participants With First Event of Centers for Disease Control and Prevention (CDC)-defined COVID-19

Primary: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

Primary: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

Primary: Number of Participants with Unsolicited Adverse Events (AEs)

Primary: Number of Participants with Unsolicited Adverse Events (AEs)

Primary: Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs)

Primary: Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs)

Secondary: GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G

Secondary: GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G

Secondary: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G at Days 91, 181, and 365

Secondary: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G at Days 91, 181, and 365

Secondary: Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)

Secondary: Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Outside EU/EEA

Clinical trials

Clinical Trial Results: A Randomized, Observer-blind, Active-controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283 Compared With mRNA-1273 in Participants Aged ≥12 Years for the Prevention of COVID-19

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Geometric Mean (GM) of Omicron BA.4/5 at Day 29

Primary: Geometric Mean (GM) of Omicron BA.4/5 at Day 29

Primary: Seroresponse Rate (SRR) Omicron BA.4/5 at Day 29

Primary: Seroresponse Rate (SRR) Omicron BA.4/5 at Day 29

Primary: GM of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G at Day 29

Primary: GM of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G at Day 29

Primary: SRR of Ancestral SARS-CoV-2 D641G at Day 29

Primary: SRR of Ancestral SARS-CoV-2 D641G at Day 29

Primary: Number of Participants With First Event of Centers for Disease Control and Prevention (CDC)-defined COVID-19

Primary: Number of Participants With First Event of Centers for Disease Control and Prevention (CDC)-defined COVID-19

Primary: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

Primary: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

Primary: Number of Participants with Unsolicited Adverse Events (AEs)

Primary: Number of Participants with Unsolicited Adverse Events (AEs)

Primary: Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs)

Primary: Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs)

Secondary: GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G

Secondary: GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G

Secondary: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G at Days 91, 181, and 365

Secondary: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G at Days 91, 181, and 365

Secondary: Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)

Secondary: Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomized, Observer-blind, Active-controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283 Compared With mRNA-1273 in Participants Aged ≥12 Years for the Prevention of COVID-19