© 2020 Moderna Therapeutics 

Overview of Moderna’s COVID-19 Vaccine 

(mRNA-1273) 

ACIP – December 20, 2020 

Jacqueline M Miller, MD FAAP 

1 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Forward-looking statements and disclaimer 

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended including, but not 

limited to, statements concerning the timing, design, objectives and other parameters of the Phase 1, Phase 2 and Phase 3 clinical studies of mRNA-1273. In 

some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” 

“anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forwardlooking statements contain these words. The forward-looking statements in this presentation are neither promises nor guarantees, and you should not place 

undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond 

Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, 

uncertainties, and other factors include, among others: preclinical and clinical development is lengthy and uncertain, especially for a new class of medicines such 

as mRNA, and therefore our preclinical programs or development candidates may be delayed, terminated, or may never advance to or in the clinic; no 

commercial product using mRNA technology has been approved, and may never be approved; mRNA drug development has substantial clinical development 

and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the U.S. Food and Drug 

Administration (FDA), European Medicines Agency (EMA) or other regulatory agencies, the FDA, EMA or such other regulatory agencies may not agree with 

Moderna’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data 

submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of 

mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in clinical trials, preclinical work, 

overall operations, regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; 

and those risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. 

Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at 

www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in 

this presentation in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current 

expectations and speak only as of the date hereof. 

© 2020 Moderna Therapeutics 2 
 

 

 

 

 

Outline of 

Presentation 

 Brief review of : 

• mRNA platform 

• Preclinical studies 

• Phase 1 & 2 trials 

 Phase 3 safety & efficacy trial 

 Brief review of vaccine storage & handling 

 Summary 

 Q & A 

Confidential and Proprietary 3 
© 2020 Moderna Therapeutics © 2020 Moderna Therapeutics 4

mRNA Platform 

4 
 

Buffers 

A Known DNA (or RNA) Sequence Can Serve as the Basis for an mRNA 

Vaccine, Which is then Formulated with Lipid Nanoparticles (LNPs) 

Enzymes Nucleotides Lipids 

DNA mRNA mRNA + LNP Drug product 

© 2020 Moderna Therapeutics 5 
mRNA-1273 encodes for the full-length Spike Protein in the Prefusion Conformation (S-2P) 

© 2020 Moderna Therapeutics 6 
© 2020 Moderna Therapeutics © 2020 Moderna Therapeutics 7

mRNA-1273 Preclinical & Clinical Programs 

7 
 

 

 

 

 

 

© 2020 Moderna Therapeutics 

mRNA-1273 Non-clinical Results 

 Immunogenic 

• Drives robust SARS-CoV-2 specific antibody and Th1-directed CD4+ 

and CD8+ T-cell responses 

 Nonclinical animal challenge studies demonstrate 

• Full protection of mice, hamsters and non-human primates from 

SARS-CoV-2 

• Does not lead to vaccine-associated enhanced respiratory disease 

 No safety concerns identified in developmental and reproductive toxicology 

study (DART) 

Studies were performed in young and aged mice, Golden Syrian Hamster, and rhesus macaque (NHP) animal models 

8 
Study 301 

(Phase 3) 

(N=30,420) 

Efficacy, Safety, Immunogenicity 

mRNA-1273 Full Development Program Supports 

the 100-μg Dose 

Study 101

(Phase 1)

(N=120) 

Study 201

Safety Monitoring Committee safety report 

(Phase 2) Safety and Immunogenicity 

(N=600) 

Informed 100μg dose for Phase 2 and 3 

Safety and Immunogenicity, and Dose Selection 

© 2020 Moderna Therapeutics 9 
© 2020 Moderna Therapeutics 

Summary of Studies 101 and 201 mRNA-1273 

Immunogenicity Data 

 Neutralizing antibody titers observed in all participants following 

2nd dose 

 GMTs across age strata numerically higher than in pool of 

convalescent sera 

 Neutralizing antibodies persisted for at least 3 months after 2nd dose 

and remained numerically higher than convalescent sera 

 Strong Th-1 dominant, CD4+ T-cell response observed 

• Consistent results with preclinical studies 

10 
© 2020 Moderna Therapeutics © 2020 Moderna Therapeutics 11

Study 301 – Large Scale Safety & Efficacy Trial 

11 
mRNA-1273 100 μg (2 intramuscular injections) 

N=15,210 

Saline Placebo (2 intramuscular injections) 

N=15,210 

Randomized

N=30,420 

R 

Study 301: Pivotal, Randomized, Placebo-Controlled 

Evaluation of Efficacy and Safety

© 2020 Moderna Therapeutics 12 
 

Weekly D209, 

Vaccination Phase Surveillance Phase 

Study 301: Scheduled Visits and Safety Calls 

eDiary 394, 

D1: D8: D15: D22: D29: D36: D43 D50: D57: prompts D119: 759: 

First Safety Safety Safety Second Safety Safety Safety Clinic & monthly Clinic Clinic 

dose call call call dose call call call visit safety calls visit visit 

Blood Blood Blood 

sample, sample, sample 

NP swab NP swab 

COVID-19 active surveillance throughout the study 

Daily telemedicine visits for participants with COVID-19 

eDiary captures solicited local and systemic adverse reactions in all participants 

SAEs and MAAEs captured throughout the study 

Blood 

samples 

© 2020 Moderna Therapeutics 13 
 

 

 

Study 301 Primary Objective: Case Definition of Symptomatic 

COVID-19 Disease 

 Symptoms 

• ≥ 2 systemic: fever, chills, myalgia, headache, sore throat, new olfactory

and taste disorder(s) 

OR 

• ≥ 1 respiratory: cough, shortness of breath / difficulty breathing, clinical 

or radiographical evidence of pneumonia 

AND 

 Confirmed SARS-CoV-2 infection via RT-PCR 

Primary analysis: adjudicated cases occurring ≥ 14 days after dose 2

© 2020 Moderna Therapeutics 14 
 

 

 

 

 

 

 

© 2020 Moderna Therapeutics 

Study 301 Key Secondary Objective: 

Case Definition of Severe COVID-19 

 Confirmed COVID-19 as per the Primary Endpoint definition, 

plus any one of the following: 

• Clinical signs indicative of severe systemic illness, RR ≥ 30

per minute, HR ≥ 125 BPM, SpO2 ≤ 93% on room air at sea level or 

PaO2/FIO2 < 300 mm Hg 

• Respiratory failure or ARDS, evidence of shock (SBP < 90 mm Hg, DBP 

< 60 mm Hg or requiring vasopressors) 

• Significant acute renal, hepatic or neurologic dysfunction 

• Admission to ICU or death 

RR: respiratory rate; HR: heart rate; BPM: beats per minute; SpO2: oxygen saturation; PaO2/FIO2: arterial oxygen partial pressure 

over fractional inspired oxygen; mm Hg: pressure measured by millimeters of mercury; ARDS: acute respiratory distress syndrome; 

SBP: systolic blood pressure; DBP: diastolic blood pressure; ICU: intensive care unit 

15 
 

 

Study 301: Representation of Participants with Risk Factors 

Full Analysis Set 

mRNA-1273 

N=15,181 

Placebo 

N=15,170 

n % n % 

Age and health risk for severe COVID-19 

18 to < 65 without comorbid conditions 8,888 59% 8,886 59% 

18 to < 65 with comorbid conditions 2,530 17% 2,535 17% 

≥ 65 with and without comorbid conditions 3,749 25% 3,749 25% 

Comorbid conditions included chronic lung disease or moderate to severe asthma, significant cardiac 

disease, severe obesity, diabetes, liver disease, stable HIV infection 

© 2020 Moderna Therapeutics 16 
 

 

Race/Ethnicity Enrollment Distribution Compared to US Population 

Full Analysis Set 

Race 

Study 301 

(N=30,351) US Population 

% % 

White 79.2% 75.0% 

Black or African American 10.2% 14.2% 

Asian 4.6% 6.8% 

More than one race 2.1% 3.4% 

American Indian or Alaska Native 0.8% 1.7% 

Hawaiian or other Pacific Islander 0.2% 0.4% 

Other 2.1% 5.5% 

Not reported or unknown 0.9% 0% 

Ethnicity 

Hispanic or Latino 20.5% 18.4% 

EDC, US Census Bureau: ACS Demographic Estimate © 2020 Moderna Therapeutics 17 
Study 301: 23% of Participants Reported ≥ 1 Pre-Existing Medical 

Risk Factor 

Full Analysis Set 

Medical Risk Factor 

mRNA-1273 

N=15,181 

Placebo 

N=15,170 

n % n % 

Diabetes 1,435 9% 1,440 9% 

Severe obesity (BMI >40 kg/m2) 1,025 7% 1,021 7% 

Chronic lung disease 710 5% 744 5% 

Significant cardiac disease 752 5% 744 5% 

Liver disease 100 < 1% 96 < 1% 

HIV 92 < 1% 87 < 1% 

© 2020 Moderna Therapeutics 18 
 

 

 

Study 301: Participants with Occupational Risk Factors Under 

Consideration for Priority Vaccination 

Full Analysis Set ― Primary Efficacy Analysis

mRNA-1273 

N=15,181 

Placebo 

N=15,170 

n % n % 

Healthcare workers 3,790 25% 3,831 25% 

Educators and students 1,543 10% 1,552 10% 

Pastoral, social, or public health workers 533 4% 503 3% 

Transportation and delivery services 482 3% 473 3% 

Personal care and in-home services 469 3% 469 3% 

Manufacturing and production operations 425 3% 421 3% 

Emergency response 302 2% 297 2% 

Warehouse shipping and fulfillment centers 191 1% 175 1% 

Border protection and military personnel 69 0.5% 68 0.4% 

© 2020 Moderna Therapeutics 19 
 

Study 301: Primary Efficacy Objective Met, VE Against Confirmed, 

Symptomatic COVID-19 Cases is > 94% 

Per Protocol 

Confirmed, Symptomatic COVID-19 Cases 

Primary Efficacy Analysis 

mRNA-1273 

N=14,134 

Placebo 

N=14,073 

Number of cases, n (%) 11 (< 0.1%) 185 (1.3%) 

Vaccine efficacy based on hazard ratio 94.1% 

(95% CI) (89.3%, 96.8%) 

p-value < 0.0001 

Incidence rate per 1000 person-years 3.3 56.5 

© 2020 Moderna Therapeutics 20 
 

 

 

 

 

 

 

 

 

Study 301: Subgroup Analyses of Efficacy are Consistent 

with Primary Analysis 

Per Protocol ― Primary Efficacy Analysis

Subgroup 

# Events / N 

Vaccine Efficacy 

(95% CI) 

Vaccine Efficacy 

(95% CI) 

mRNA-1273 

N=14,134 

Placebo 

N=14,073 

Overall 11 / 14,134 185 / 14,073 94.1% (89.3%, 96.8%) 

Age and risk 

18 to < 65 without comorbidities 

18 to < 65 with comorbidities 

≥ 65 with or without comorbidities 

65 to < 70 with or without comorbidities 

≥ 70 with or without comorbidities

5 / 8,396 

2 / 2,155 

4 / 3,583 

4 / 2,953 

0 / 630 

121 / 8,403 

35 / 2,118 

29 / 3,552 

22 / 2,864 

7 / 688 

95.9% (90.0%, 98.3%) 

94.4% (76.9%, 98.7%) 

86.4% (61.4%, 95.2%) 

82.4% (46.9%, 93.9%) 

100% (NE, 100) 

Sex 

Male 

Female 

4 / 7,366 

7 / 6,768 

87 / 7,462 

98 / 6,611 

95.4% (87.4%, 98.3%) 

93.1% (85.2%, 96.8%) 

Participants with comorbidities (all ages) 

Yes 

No 

4 / 3,206 

7 / 10,928 

43 / 3,167 

142 / 10,906 

90.9% (74.7%, 96.7%) 

95.1% (89.6%, 97.7%) 

Race and Ethnicity 

Non-Hispanic White 

Communities of Color 

10 / 9,023 

1 / 5,088 

144 / 8,916 

41 / 5,132 

93.2% (87.1%, 96.4%) 

97.5% (82.2%, 99.7%) 

0 20 40 60 80 100 

NE: not estimable 

© 2020 Moderna Therapeutics 21 
 

 

 

 

 

 

Study 301 Secondary Efficacy Endpoint: 

Cases of Confirmed Severe COVID-19 

Per Protocol 

Confirmed, Severe COVID-19 Cases 

Primary Efficacy Analysis 

mRNA-1273 

N=14,134 

Placebo 

N=14,073 

Number of cases, n (%) 0 (0%) 30 (0.2%) 

Vaccine efficacy based on hazard ratio 100% 

(95% CI) (NE, 100%) 

Incidence rate per 1000 person-years 0 9.1 

• One participant death due to COVID-19 in the placebo group 

• Given the high efficacy against severe disease, no evidence for vaccine-associated enhanced disease 

was observed 

One potential case of severe disease was reported in the mRNA-1273 group after data cut-off for the 

primary efficacy analysis, this case has yet to be adjudicated. 

NE: not estimable 

© 2020 Moderna Therapeutics 22 
Kaplan-Meier Estimates of Time to First Occurrence of COVID -19 

Starting After Randomization 

mITT – Interim Analysis 

2.5 Placebo 

2.0 

Cumulative 

Event Rate 

% 

1.5 

1.0 

Vaccine efficacy = 95.2% 

95% CI, (91.2%, 97.4%) 

0.5 

0 

mRNA-1273 

1st Dose 2nd Dose 

0 10 20 30 40 50 60 70 80 90 100 110 

No. at risk 

Time from Randomization (Day) 

mRNA-1273 14312 14306 13964 13490 12981 12284 10742 8327 5705 2621 583 0 

Placebo 14370 14363 14000 13515 12972 12225 10657 8283 5663 2594 586 0 

© 2020 Moderna Therapeutics 23 
 

Study 301: Summary of COVID-19 Cases Within 6 Weeks After 

Randomization Based on CDC Case Definition1 

mITT Population – Interim Analysis 

mRNA-1273 Placebo 

N=14,550 N=14,598 

n n 

From randomization to 14 days post 1st dose 5 11 

From 14 days post 1st dose to 2nd dose 3 34 

From 2nd dose to 14 days post 2nd dose 0 17 

Total 8 62 

Data suggest protection may begin prior to dose 2 

1 One clinical symptom from an expanded list and a nasopharyngeal swab positive for SARS-CoV-2 virus 

© 2020 Moderna Therapeutics 24 
 

 

 

Study 301: Summary of Asymptomatic SARS-CoV-2 Infections as Measured by 

Scheduled NP Swabs Prior to 2nd Dose 

Per Protocol ― Primary Efficacy Analysis

RT-PCR NP Swab Results 

mRNA-1273 

N=14,134 

Placebo 

N=14,073 

n % N % 

No documented COVID-19 symptoms between 14 0.1% 38 0.3% 1st dose and 2nd dose 

Data suggestive of efficacy for prevention of asymptomatic infection 

© 2020 Moderna Therapeutics 25 
© 2020 Moderna Therapeutics © 2020 Moderna Therapeutics 26

Study 301: mRNA-1273 100 μg Safety 

9-Week Median Follow-up 

26 
© 2020 Moderna Therapeutics © 2020 Moderna Therapeutics 27

Solicited Adverse Reactions 

Study 301 Safety Set (N=30,351) 

27 
 

 

Study 301: Most Solicited Local Adverse Reactions Were 

Mild-to-Moderate (1st Injection) 

Safety Set, 9-Week Median Follow-up 

100% 

80% 

60% 

mRNA-1273 

40% 

20% 

0% 

100% 

80% 

60% 

Placebo 

40% 

20% 

0% 

1st Injection 

Pain Erythema Swelling Ax. Swelling or Tenderness* 

19% 

13% 

0.4% 0.5% 0.3% 0.5% 5% 4% 

≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 

Grade 3 

Grade 2 

Grade 1 

87% 

74% 

3% 2% 7% 4% 

12% 6% 

≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 

Note: Includes reports within 7 days of injection. *Localized axillary swelling or tenderness ipsilateral to the vaccination arm. 

© 2020 Moderna Therapeutics 28 
 

 

Study 301: Most Solicited Local Adverse Reactions Were 

Mild-to-Moderate (2nd Injection) 

Safety Set, 9-Week Median Follow-up 

100% 

80% 

60% 

mRNA-1273 

40% 

20% 

0% 

100% 

80% 

60% 

Placebo 

40% 

20% 

0% 

19% 

12% 

0.4% 0.4% 0.3% 0.4% 4% 3% 

2nd Injection 

Pain Erythema Swelling Ax. Swelling or Tenderness* 

90% 

83% 

9% 8% 13% 11% 

16% 

9% 

≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 

Grade 3 

Grade 2 

Grade 1 

≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 

Note: Includes reports within 7 days of injection. *Localized axillary swelling or tenderness ipsilateral to the vaccination arm. 

© 2020 Moderna Therapeutics 29 
 

Study 301: Most Solicited Systemic Adverse Reactions Were Mild-toModerate (1st Injection) 

Safety Set, 9-Week Median Follow-up 

100% 

80% 

mRNA 60% -1273 

40% 

20% 

0% 

100% 

80% 

Placebo 60% 

40% 

20% 

0% 

1st Injection 

Fatigue Headache Myalgia Arthralgia Chills Nausea/Vomiting Fever 

38% 33% 

≥ 18 to < 65 ≥ 65 

35% 

25% 

≥ 18 to < 65 ≥ 65 

24% 20% 

≥ 18 to < 65 ≥ 65 

17% 16% 

≥ 18 to < 65 ≥ 65 

9% 5% 

≥ 18 to < 65 ≥ 65 

9% 5% 

≥ 18 to < 65 ≥ 65 

Grade 4 

Grade 3 

Grade 2 

Grade 1 

0.9% 0.3% 

≥ 18 to < 65 ≥ 65 

29% 23% 29% 

19% 14% 12% 12% 12% 6% 4% 8% 4% 0.3% 0.2% 

≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 

Note: Solicited Systemic ARs include reports within 7 days of injection 

© 2020 Moderna Therapeutics 30 
 

Study 301: Most Solicited Systemic Adverse Reactions Were 

Mild-to-Moderate (2nd Injection) 

Safety Set, 9-Week Median Follow-up 

100% 

80% 

mRNA 60% -1273 

40% 

20% 

0% 

100% 

80% 

Placebo 60% 

40% 

20% 

0% 

2nd Injection 

Fatigue Headache Myalgia Arthralgia Chills Nausea/Vomiting Fever 

68% 

58% 

≥ 18 to < 65 ≥ 65 

63% 

46% 

≥ 18 to < 65 ≥ 65 

62% 

47% 

≥ 18 to < 65 ≥ 65 

46% 

35% 

≥ 18 to < 65 ≥ 65 

49% 

31% 

≥ 18 to < 65 ≥ 65 

21% 

12% 

≥ 18 to < 65 ≥ 65 

Grade 4 

Grade 3 

Grade 2 

Grade 1 

17% 

10% 

≥ 18 to < 65 ≥ 65 

25% 20% 25% 

18% 13% 11% 11% 11% 6% 4% 7% 4% 0.4% 0.1% 

≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 ≥ 18 to < 65 ≥ 65 

Note: Solicited Systemic ARs include reports within 7 days of injection 

© 2020 Moderna Therapeutics 31 
Study 301: Any Solicited Adverse Reaction by Baseline 

SARS-CoV-2 Status 

Safety Set, 9-Week Median Follow-up 

Grade 2 Grade 4 

Grade 1 Grade 3 

Local Systemic 

mRNA-1273 Placebo mRNA-1273 Placebo 

0% 

20% 

40% 

60% 

80% 

100% 

Positive Negative Positive Negative Positive Negative Positive Negative 

79% 

93% 

23% 

30% 

70% 

84% 

42% 

54% 

Subjects 

% 

Missing baseline SARS-CoV-2 assessment for 288 mRNA-1273 and 235 Placebo participants 

© 2020 Moderna Therapeutics 32 
© 2020 Moderna Therapeutics © 2020 Moderna Therapeutics 33

Unsolicited Adverse Events 

Study 301 Safety Set (N=30,351) 

33 
Study 301: Summary of Unsolicited AEs 

Safety Set, 9-Week Median Follow-up 

Unsolicited Adverse Events 

mRNA-1273 

N=15,185 

Placebo 

N=15,166 

n % n % 

Any Adverse Event 4,058 27% 3,888 26% 

Any Medically-Attended Adverse Event (MAAE) 1,745 11% 1,958 13% 

Any Serious Adverse Event (SAE) 147 1% 153 1% 

Any death (reported through December 3, 2020) 6 < 0.1% 7 < 0.1% 

© 2020 Moderna Therapeutics 34 
Study 301: Rates of Medically-Attended AEs Were Comparable 

Between Groups 

Safety Set, 9-Week Median Follow-up 

3.8% 

1.4% 1.3% 1.3% 1.2% 1.0% 1.0% 0.7% 

5.5% 

1.4% 1.4% 1.2% 1.5% 1.1% 1.0% 0.7% 

0% 

10% 

20% 

30% 

40% 

50% 

Rate 

by 

SOC 

mRNA-1273 

Placebo 

Infections 

and 

Infestations 

Musculoskeletal 

and 

Connective 

Injury,

Poisoning,

and 

GI Disorders Respiratory,

Thoracic, 

and 

Nervous 

System

Disorders 

General 

Disorders 

and 

Vascular 

Disorders 

Tissue Procedural Mediastinal Administration 

Disorders Complications Disorders Site 

System Organ Class (SOC) occurring at rate > 0.6% 

© 2020 Moderna Therapeutics 35 
5% 

mRNA-1273 

4% 

Placebo 

3% Rate 

by 

SOC 

2% 

1% 

0.2% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.2% 0.2% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 

0% 

GI Cardiac Infections Injury, Nervous Neoplasms Respiratory, Musculoskeletal Vascular 

Disorders Disorders and Poisoning, System Benign, Thoracic, and Disorders 

Infestations and Disorders Malignant, and Connective 

Procedural and Mediastinal Tissue 

Complications Unspecified Disorders Disorders 

(incl. cysts

and polyps) 

Study 301: Rates of SAEs Were Comparable Between Groups 

Safety Set, 9-Week Median Follow-up 

System Organ Class (SOC) occurring at rate > 0.05% 

© 2020 Moderna Therapeutics 36 
Study 301: Deaths Through December 3, 2020 

Preferred Term 

mRNA1273 

n=6 

Placebo 

n=7 

Relationship to 

Treatment 

Abdominal injury (intra-abdominal perforation) 0 1 Not related 

Cardio-respiratory arrest 1 1 Not related 

Completed suicide 1 0 Not related 

COVID-19 0 1 Not related 

Head injury 1 0 Not related 

Myocardial infarction 1 2 Not related 

Multisystem organ failure 1 0 Not related 

Not otherwise specified 1 1 Not related 

Systemic inflammatory response syndrome 

(dermatitis bullous) 0 1 Not related 

© 2020 Moderna Therapeutics 37 
 

© 2020 Moderna Therapeutics 38 

Investigations Unable to Identify Cases Suggestive of 

Anaphylaxis Associated with mRNA-1273 

 No participants excluded for history of anaphylaxis, urticaria, or other 

significant hypersensitivity 

 2 anaphylactic reactions reported as unsolicited AEs 

• 1 placebo occurring 10 days after 1st dose 

• 1 mRNA-1273 occurring 63 days after 2nd dose 

 Conducted anaphylaxis Standardized MedDRA Query (SMQ), 

including review of events within 48 hours 

• 0 met Brighton Collaboration Anaphylaxis Case Definition 
Moderna Committed to Collecting Additional Data in a 

Broader Range of Patients 

 Pediatric studies ongoing 

 National Cancer Institute collaboration 

 Post-authorization active surveillance and safety study 

 Global pregnancy registry under development 

 Post-authorization effectiveness study 

Moderna will continue to collaborate with NIH, FDA, CDC and other agencies 

© 2020 Moderna Therapeutics 39 
© 2020 Moderna Therapeutics © 2020 Moderna Therapeutics 40

Vaccine Storage & Handling 

40 
 

 

 

mRNA-1273 Shipping, Storage and Administration 

Local Storage Options 

(up to the Date of Expiration) 

Multiple-dose vial 

Freezer 

-15 to -25° C

Refrigerator 

2 to 8°C 

up to 30 days 

Use within 6 hours 

after first entry 

No dilution required 

-20°C

Local transportation under 

controlled condition at 2 to 8°C 

Administration 

Room Temperature 

up to 12 hours 

Shipping 

-20°C (-40°C to -15°C)

Able to ship a single 

carton 

(100 doses) 

© 2020 Moderna Therapeutics 41 
 

 

 

 

 

 

 

Summary: mRNA-1273 Offers Potential to Address the Public 

Health Crisis of COVID-19 

 Efficacy

• 94.1% efficacy demonstrated in primary analysis on 196 cases 

• Primary efficacy hypothesis was met 

o Lower limit of 95% CI was 89.3%, exceeding pre-specified 30% margin 

• Reduced severe COVID-19 disease 

o 0 vs 30 cases in vaccine and placebo groups, respectively 

• Other secondary, sensitivity and subgroup analyses support primary efficacy analysis results 

 Safety

• Acceptable tolerability profile was observed with >96% of subjects having received second 

dose 

o More solicited events were reported after the second dose 

o Majority of reported solicited adverse events were mild-to-moderate in severity and short-lived in duration 

• Overall safety profile is clinically acceptable 

 Vaccine has the potential to address the SARS-CoV-2 pandemic and has been 

authorized for Emergency Use 

© 2020 Moderna Therapeutics 42 
 

 

 

 

 

 

© 2020 Moderna Therapeutics 

Thank you to our collaborators, investigators and subjects 

P101 P201 COVE Study (P301) 

 Division of Microbiology and Infectious 

Diseases, NIAID 

 Vaccine Research Center (VRC), NIAID 

 Coalition for Epidemic Preparedness 

Innovation 

 Principal Investigators, Drs. Lisa Jackson 

(Kaiser Permanente Washington), Evan 

Anderson (Emory University School of 

Medicine), Nadine Rouphael (Emory 

University School of Medicine), Alicia Widge 

(VRC) 

 The Emmes Company 

 Denison Lab, Vanderbilt University 

 Baric Lab, University of North Carolina 

 Suthar Lab, Emory University 

 Vaccine Immunology Program, NIAID 

 Study sites, investigators and subjects 

 BARDA 

 Study sites, investigators, and 

subjects 

 BARDA 

 Operation Warp Speed 

 NIAID and the COVID-19 

Prevention Network 

 Members of Diversity and 

Inclusion Panel 

 Principal Investigators, Drs. 

Brandon Essink (Meridian Clinical 

Research), Lindsey Baden 

(Brigham and Women’s Hospital), 

Hana El Sahly (Baylor College of 

Medicine) 

 Study sites, investigators, and 

subjects 

43