AP-1 

Overview of Janssen’s Single-Dose 

COVID-19 Vaccine, Ad26.COV2.S 

Janssen Pharmaceutical Companies 

of Johnson & Johnson 

US Centers for Disease Control and Prevention 

Advisory Committee on Immunization Practices 

February 28, 2021 
AP-2 

Introduction 

Macaya Douoguih, MD, MPH 

Head of Clinical Development and Medical Affairs 

Janssen Pharmaceuticals Companies of Johnson & Johnson 
 

 

 

 

AP-3 

Janssen’s Vaccine Candidate (Ad26.COV2.S)

Supports Global Effort to Fight COVID-19 

 Phase 3 study enrolled > 44,000 participants and was conducted 

during height of pandemic 

 Offers substantial protection, especially against severe COVID-19 

including hospitalization and death, irrespective of variant 

 Well-tolerated and safe 

 Single-dose regimen with storage, transportation conditions 

compatible within existing distribution channels 
 

 

 

 

 

 

 

AP-4 

Key Efficacy Findings from Ad26.COV2.S Single-Dose Study

Demonstrate Protection Against Symptomatic COVID-19 

85% vaccine efficacy* against severe COVID-19 globally, including the United States 

• Consistent vaccine efficacy against severe disease across all regions 

• Equally high protection in South Africa (n > 6,500) where B.1.351 is highly prevalent (> 95%) 

• Complete protection against COVID-19 related hospitalizations as of day 28 and no COVID-19 related 

deaths in the Ad26 group compared to 5 in the placebo group 

66% vaccine efficacy* against moderate to severe/critical COVID-19 across all countries 

• Protection as of 2 weeks after vaccination 

72% vaccine efficacy* against moderate to severe/critical COVID-19 in the United States 

• Participants reflected diversity of US population (n > 19,000) 

Similar vaccine efficacy demonstrated by age, comorbidities status, sex, race, 

and ethnicity 

*> Day 28 
 

 

 

 

 

 

AP-5 

Vaccine Efficacy (VE) Results Support Protection

Against Emerging Variants 

Trial conducted in areas where COVID-19 incidence was highest 

and where variants were emerging 

% variant 

95% B.1.351 lineage 

3% D614G 

% variant 

69% P.2 lineage 

31% D614G 

% variant 

96% D614G 

3% CAL.20C 

COV3001 site locations 

Countries with emerging variants 

United States 

86% VE 

severe/ 

critical 

Brazil 

88% VE 

severe/ 

critical 82% VE 

severe/ 

critical 

South Africa 

VE based on total dataset, including non-centrally PCR confirmed cases 
 

AP-6 

Logistical, Practical Advantages to Help Simplify Distribution

and Expand Vaccine Access of Single Dose Ad26.COV2.S 

Single, 0.5ml 

dose offers ability 

to vaccinate 

population faster 

Stored for 3 

months at 

normal 

refrigerator 

temperatures, 

2° to 8° C 

(36° to 46° F) 

2-year shelf life 

when frozen, 

-25° to -15° C 

(-13° to 5° F) 

Prepared for 

large-scale 

manufacturing 

20 million doses 

by end of March 

100 million 

doses to US in 

first half of 2021 

Shipping fits 

into existing 

supply chain 

infrastructure 

5 doses per vial 

No dilution 

required 
 

AP-7 

Substantial Experience with Adenovirus 26-based

Vaccines 

• Local, systemic reactogenicity in line with other licensed vaccines 

• Database searches for AESIs revealed no safety signals 

• Across continents 

• Healthy adults 

• Elderly > 65 years 

• Breastfeeding, pregnant women within Ebola program 

• Various races, ethnicities 

• Infants ≥ 4 months

• People with HIV 

Substantial clinical 

experience with 

Ad26-based vaccines 

(N > 193,000) 

Regular database 

reviews show good 

tolerability, safety 

AESIs: Adverse Events of Special Interest 
AP-8 

Comprehensive Development Program

Key Studies 

Preclinical 

Animal Studies Including non-human primate (NHP) studies 

Immunogenicity, efficacy 

Phase 1/2a 

COV1001 

First in Human (FIH) study 

Safety, immunogenicity, and dose selection 

Phase 2 

COV2001 

Lower dosing and different intervals 

Safety, immunogenicity in adolescents and adults 

Phase 3 

COV3001 

(ENSEMBLE) 

Focus of EUA, single-dose pivotal study 

Efficacy, safety, and immunogenicity 
 

AP-9 

Additional Key Studies 

 COV3009: two-dose regimen Phase 3 efficacy study 

 Results estimated to be available late this year 

 Immunogenicity and safety studies in children, 0 – 17 years 

 Adolescent study will open enrollment soon 

 Pregnant women 

 Planned to begin late March/early April 2021 

 Immunocompromised individuals 

 Planned to begin Q3 2021 

 Post-authorization observational studies 

 Including pregnancy exposure registry 
AP-10 

Vaccine Design and Immunogenicity 
 

AP-11 

Ad26 Vector is Replication Incompetent 

Adenovirus Ψ

genome 

E1 E3 

Replication Incompetent 

vector 

Complementing 

Cell Line Transgene 

 Janssen Ad26 vector can not replicate 

in the human body 

 Cell line grows in medium free of animal 

components 

 Vial of Ad26-based vaccine contains buffer with 

commonly used ingredients in vaccines 

 No adjuvants, no antibiotics, no preservatives Vaccine Vectors 
I.M. 

injection of 

Ad26.COV2.S HUMAN CELL 

Transgene expression 

Spike protein 

Adenoviral 

vectors 

classified as 

non-integrating* 

Ad26.COV2.S 

CELLULAR IMMUNITY 

Cytotoxic 

CD8+ T cell 

CD8+ 

T cell 

B cell 

CD4+ 

T cell 

APC 

APC 

HUMORAL IMMUNITY 

Spike-specific Antibodies 

Plasma cell 

LYMPH NODE 

*FDA Guidance, 2020 

AP-12 

Ad26.COV2.S Expresses SARS-CoV-2 Spike Protein, 

Eliciting Multiple Immune Responses 
 

 

AP-13 

Single-Dose Ad26.COV2.S Fully Protects Against 

SARS-CoV-2 Challenge in Non-Human Primates (NHP) 

 Protection against viral replication 

 Near complete protection in nose 

 Full protection in lung 

 Durability > 6 months 

 Protection seen even with 4-fold lower vaccine dose 

 Nearly full protection in aged NHP 

 Protection in Syrian golden hamsters, no VAED 

 Results met FDA criteria to progress to human clinical trials 

VAED = Vaccine Associated Enhanced Disease 
 

 

 

 

 

 

 

 

 

AP-14 

Summary of Phase 1/2 Immunogenicity Data 

Following Single Dose of Ad26.COV2.S 

 Neutralizing antibody titers elicited in 96% of adults, 

independent of age 

 Titers detected as early as 14 days post vaccination 

 Increased to Day 57 and maintained thereafter 

 Strong CD8+ and Th1 dominated CD4+ T cell responses 

 Minimizes risk for vaccine associated enhanced disease (VAED) 

 Both doses had favorable safety profile 

 Lower dose more favorable reactogenicity profile 

 Ad26.COV2.S 5x1010 vp dose selected for COV3001 
AP-15 

Phase 3 Study COV3001 (ENSEMBLE)

Efficacy and Safety 
 

AP-16 

COV3001: Randomized, Double-Blind, Phase 3 Trial 

 Evaluating efficacy, safety, immunogenicity of single dose of Ad26.COV2.S 

A d 2 6 . C O V 2 . S 

(5 × 1 0 10 vp ) 

P l a c e b o 

( s a l i n e ) 

Randomized Received 

Injection 

 Randomization stratified by site, age group, and absence / presence of comorbidities 
 

AP-17 

COV3001: Began Enrollment with Safety Run-in Phase 

Stage 1a safety run in 

• ~2,000 adults 18 – 59 years 

without comorbidities 

Stage 1b initiated following 

DSMB review of 1a data 

• Adults 18 – 59 years with 

and without comorbidities 

Stage 2a safety run in 

• ~2,000 adults ≥ 60 years

without comorbidities 

Stage 2b initiated following 

DSMB review of 2a data 

• Adults ≥ 60 years with 

and without comorbidities 

Study targeted at least 30% of total study population to be ≥ 60 years
 

AP-18 

COV3001: Co-Primary Endpoints 

at least 28 days after vaccination 

at least 14 days after vaccination Vaccine efficacy to prevent 

moderate to severe/critical 

COVID-19 

 Primary Hypothesis: lower limit of 95% confidence interval > 30% 

Per Protocol Population 
 

 

 

 

 

 

AP-19 

COV3001: Case Definition for Moderate COVID-19 

RT-PCR or molecular test confirmation of SARS-CoV-2 infection 

AND 

At any time during observation period: 

≥ 1 new or worsening sign or symptom

 

 

















Respiratory rate ≥ 20 bpm Fever  Malaise 

Abnormal oxygen saturation 

(> 93% on room air) 

Heart rate ≥ 90 bpm

Shaking chills 

 Headache 

 Cough 

Evidence of pneumonia 

Deep vein thrombosis (DVT) 

Shortness of breath 

OR Muscle pain  Sore throat 

Changes to olfaction or taste 

Gastrointestinal symptoms 

Red or bruised feet or toes 

≥ 2 new or worsening sign or symptoms
 

 

 

 

 

 

 

 

 

AP-20 

COV3001: 

Case Definition for Severe/Critical COVID-19 

RT-PCR or molecular test confirmation of SARS-CoV-2 infection 

AND 

At any time during observation period: 

≥ 1 of these signs or symptoms

 Clinical signs indicative of severe systemic illness: Respiratory rate ≥ 30 bpm,

heart rate ≥ 125 bpm, SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300 mmHg 

 Respiratory failure: Needing high-flow oxygen, non-invasive ventilation, mechanical 

ventilation, or extracorporeal membrane oxygenation [ECMO] 

 Evidence of shock: Systolic blood pressure < 90 mmHg, diastolic blood pressure 

< 60 mmHg, or requiring vasopressors 

 Significant acute renal, hepatic, or neurologic dysfunction 

 Admission to ICU 

 Death 
AP-21 

Study COV3001:

Disposition and Efficacy Results 
AP-22 

COV3001 Disposition of Participants 

Received Injection 

N=43,783 

Randomized 

N=44,325 

Ad26.COV2.S 

N=21,895 

Placebo 

N=21,888 

Full Analysis Set (FAS) 

Safety Population 

N=19,630 (90%) 

Per Protocol (PP) 

Primary Efficacy Population 

Seronegative at Baseline 

N=39,321 

N=19,691 (90%) 

PP At Risk Set* 

Day 14: N=39,058 

Day 28: N=38,484 

Day 14: N=19,514 (89%) 

Day 28: N=19,306 (88%) 

Day 14: N=19,544 (89%) 

Day 28: N=19,178 (88%) 

*PP At Risk set: excluded participants with positive polymerase chain reaction (PCR) test for SARS-CoV-2 between vaccination and day of efficacy assessment 
AP-23

COV3001: No Relevant Differences at Baseline 

Between Vaccine and Placebo Groups Globally

Race

American Indian or Alaska Native 2,083 10% 2,060 9%

Asian 743 3% 687 3%

Black or African American 4,251 19% 4,264 20%

Native Hawaiian or other Pacific Islander 58 0.3% 48 0.2%

White 12,858 59% 12,838 59%

Multiple, unknown, not reported 1,901 9% 1,989 9%

Ethnicity

Hispanic or Latino 9,874 45% 9,963 46%

Ad26.COV2.S

N = 21,895

Placebo

N = 21,888

Full Analysis Set n % n %

Sex, female 9,820 45% 9,902 45%

Mean Age (SD), years 50.7 (15.0) 50.7 (15.0)

Age group

18-59 14,564 67% 14,547 66%

≥ 60 7,331 33% 7,341 34%

≥ 65 4,259 19% 4,302 20%

≥ 75 809 4% 732 3%
4,292 45% 4,256 44% 

Mean Age (SD), years 53.0 (14.7) 53.2 (14.7) 

Age group 

18-59 5,894 61% 5,870 61% 

≥ 60 3,761 39% 3,777 39% 

≥ 65 2,299 24% 2,369 25% 

≥ 75 445 5% 416 4% 

Race 

American Indian or Alaska Native 92 1% 95 1% 

Asian 655 7% 597 6% 

Black or African American 1,246 13% 1,264 13% 

Native Hawaiian or other Pacific Islander 47 0.5% 41 0.4% 

White 7,104 74% 7,090 74% 

Multiple, unknown, not reported 510 5% 558 6% 

Ethnicity 

Hispanic or Latino 1,381 14% 1,454 15% 

AP-24 

COV3001: Similar Baseline Demographics Between

Vaccine and Placebo Groups in US 

Ad26.COV2.S 

N = 9,655 

n % 

Placebo 

N = 9,647 

Full Analysis Set n % 

Sex, female 
 

 

AP-25 

COV3001: Global Participants with Comorbidities

Similar Between Vaccine and Placebo Groups 

Full Analysis Set 

Baseline Comorbidity* Category, ≥ 2%

Ad26.COV2.S 

N = 21,895 

Placebo 

N = 21,888 

n % n % 

≥ 1 risk factor 8,936 40.8% 8,922 40.8% 

Obesity ≥ 30 kg/m2 6,277 28.7% 6,215 28.4% 

Hypertension 2,225 10.2% 2,296 10.5% 

Type 2 Diabetes Mellitus 1,600 7.3% 1,594 7.3% 

Serious heart conditions 497 2.3% 511 2.3% 

*Pre-existing medical risk factor for developing severe COVID-19 
 

 

AP-26 

COV3001: US Participants with Comorbidities 

Similar Between Vaccine and Placebo Groups 

Full Analysis Set 

Baseline Comorbidity* Category, ≥ 2%

Ad26.COV2.S 

N = 9,655 

Placebo 

N = 9,647 

n % n % 

≥ 1 risk factor 4,227 43.8% 4,247 44.0% 

Obesity ≥ 30 kg/m2 3,085 32.0% 3,054 31.7% 

Hypertension 1,139 11.8% 1,166 12.1% 

Type 2 Diabetes Mellitus 743 7.7% 729 7.6% 

Serious heart conditions 291 3.0% 304 3.2% 

Asthma 160 1.7% 203 2.1% 

*Pre-existing medical risk factor for developing severe COVID-19 
 

 

 

 

AP-27 

COV3001 Met Co-Primary Endpoints: Ad26.COV2.S Protects

Against Moderate to Severe/Critical COVID-19 Globally 

> Day 14 > Day 28 

PP At Risk Set 

Ad26.COV2.S 

N = 19,514 

Placebo 

N = 19,544 

Ad26.COV2.S 

N = 19,306 

Placebo 

N = 19,178 

Number of confirmed cases, n 116 348 66 193 

Person-years 3,117 3,096 3,102 3,071 

Vaccine efficacy (adjusted 95% CI) 66.9% 

(59.0, 73.4) 

66.1% 

(55.0, 74.8) 

COV3001; confirmed: positive PCR centrally confirmed COVID-19 cases, global data 
 

 

 

 

 

 

AP-28 

Ad26.COV2.S Protects Against Moderate to

Severe/Critical COVID-19 in US Population 

> Day 14 > Day 28 

PP At Risk Set 

Ad26.COV2.S 

N = 9,119 

Placebo 

N = 9,086 

Ad26.COV2.S 

N = 8,958 

Placebo 

N = 8,835 

Number of cases, n 51 196 32 112 

Person-years 1,414 1,391 1,403 1,376 

Vaccine efficacy (95% CI) 74.4% 

(65.0, 81.6) 

72.0% 

(58.2, 81.7) 

COV3001; non-confirmed: all COVID-19 cases with a positive PCR from any source, regardless of central confirmation 
 

 

AP-29 

Kaplan Meier Shows Early Onset of Protection 

Against Moderate to Severe/Critical COVID-19 

Placebo 

3 

2 

Cumulative 

Incidence Ad26.COV2.S 

% 

1 

0 

0 7 

Participants at risk 

Ad26.COV2.S 19744 19725 19669 19642 19612 19578 18541 14909 10930 7831 3998 1468 713 484 483 482 142 31 0 

Placebo 19822 19804 19745 19652 19579 19488 18411 14814 10823 7740 3876 1439 708 485 482 480 133 27 0 

Cumulative number of cases 

Ad26.COV2.S 0 27 76 96 126 151 168 178 184 188 189 191 191 192 193 193 193 193 193 

Placebo 0 22 81 168 237 299 351 387 407 416 423 425 430 432 432 432 432 432 432 

COV3001; Full Analysis Set; baseline seronegative; confirmed: positive PCR centrally confirmed COVID-19 cases 

Separation begins 

as early as Day 14 

Severe cases marked as circles 

14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126 

Time to First Occurrence (days post vaccination) 
AP-30

Use of Larger Dataset Justified

Cases (N)

COVID-19 Case Data Set > Day 14 > Day 28 Assessment 

Molecularly (PCR) confirmed by central laboratory 

(confirmed) 464 259 Co-primary and secondary efficacy analyses 

Global vaccine efficacy: moderate to 

severe/critical COVID-19 66.9% 66.1%

PCR+ test from any source, regardless of central 

laboratory confirmation (non-confirmed) 682 437

Subgroup analyses, 

COVID-19 hospitalizations, 

COVID-19-related deaths

Global vaccine efficacy: moderate to 

severe/critical COVID-19 66.3% 65.5%

Vaccine efficacy results differed between data sets by < 1% at both timepoints

High concordance (90%) between COVID-19 case datasets

COV3001
AP-31 

Study COV3001:

Key Secondary and Other Endpoints 

 Vaccine efficacy against severe/critical COVID-19 

 Vaccine impact on hospitalization and prevention of death 

 Vaccine impact on asymptomatic/undetected COVID-19 
 

 

 

AP-32 

High Vaccine Efficacy Against Severe/Critical COVID-19 

> Day 14 > Day 28 

PP At Risk Set 

Ad26.COV2.S 

N = 19,514 

Placebo 

N = 19,544 

Ad26.COV2.S 

N = 19,306 

Placebo 

N = 19,178 

Number of confirmed cases, n 14 60 5 34 

76.7% 

(54.6, 89.1) 

85.4% 

(54.2, 96.9) Vaccine efficacy (adjusted 95% CI) 

COV3001; confirmed: positive PCR centrally confirmed COVID-19 cases 
Placebo 

0.5 

0.4 

Cumulative 0.3 

Incidence 

% 0.2 

0.1 Ad26.COV2.S 

0 

Separation begins 

~ Day 7 

Day 48 

0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126 

Time to First Occurrence (in days since vaccination) 

AP-33 

Time to First Occurrence of Severe/Critical COVID-19 

Demonstrates Early Onset of Protection 

Participants at risk 

Ad26.COV2.S 19744 19741 19734 19725 19718 19705 18685 15043 11046 7919 4039 1481 720 490 490 489 146 31 0 

Placebo 19822 19817 19799 19779 19760 19725 18682 15088 11069 7939 3995 1485 732 500 497 495 137 29 0 

Number of cases 

Ad26.COV2.S 0 3 7 11 16 18 20 21 21 21 21 21 21 21 21 21 21 21 21 

Placebo 0 5 18 32 44 55 65 73 76 76 77 77 78 78 78 78 78 78 78 

COV3001; Full Analysis Set; baseline seronegative; confirmed: positive PCR centrally confirmed COVID -19 cases 
 

 

AP-34 

Vaccine Efficacy Against Severe/Critical COVID-19 

Increased Over Time Through Day 56 

0 

Vaccine 

Efficacy 

% 

100 

90 

80 

70 

60 

50 

40 

30 

20 

10 

Gray: 95% point-wise CI 

0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 

Time Since Vaccination (days) 

Days of follow-up 7 14 28 42 56 70 

% of participants with ~100% ~100% 99% 93% 55% 20% follow-up 

84 

4% 

98 

2% 

COV3001; Full Analysis Set; baseline seronegative; confirmed: positive PCR centrally confirmed COVID -19 cases 
Ad26.COV2.S 

Cases, n 

VE 

(95% CI) 

2 29 93.1% 

(72.7, 99.2) 

> Day 28 

PCR+ cases from any source, regardless of central 

confirmation 0 16 100.0% 

(74.3, 100.0) 

 

 

 

AP-35 

Data Support Substantial Effect on Prevention 

of COVID-19 Related Hospitalizations 

COV3001; Sources: MRU (Medical Resource Utilization), SAE, and MA-COV (medical attendance-COV) 

Onset is earliest of either AE linked to COVID-19 or onset of COVID-19 episode following SAP algorithm 

PP At Risk Set 

> Day 14 

Placebo 

Cases, n 

PCR+ cases from any source, regardless of central 

confirmation 
 

 

 

AP-36 

Ad26.COV2.S Data Support Protection Against

COVID-19-Related Deaths 

Full Analysis Set 

Through January 22, 2021 

Ad26.COV2.S 

N = 21,895 

Placebo 

N = 21,888 

All cause mortality 3 16 

COVID-19 confirmed death > Day 1 0 5 * 

*

One PCR+ participant at baseline, not included 

Full Analysis Set 

From January 22, 2021 to February 5, 2021 

Ad26.COV2.S 

N = 21,895 

Placebo 

N = 21,888 

Additional deaths reported 2 4 

COVID-19 confirmed death > Day 1 0 1 

 All COVID-19 associated deaths occurred in South Africa 

COV3001; non-confirmed: all COVID-19 cases with a positive PCR from any source, regardless of central confirmation 
 

 

 

 

 

 

 

AP-37 

Subset of Data Show Effect Against 

Asymptomatic/Undetected COVID-19 

Per Protocol 

> Day 29 

VE (95%CI) 

Ad26.COV2.S 

N = 19,630 

Placebo 

N = 19,691 

Serology Risk Set (Day 71 serology results) N = 1,346 N = 1,304 

Seroconverted SARS-CoV-2 (Day > 29)a 18 50 65.5% (39.9, 81.1) 

Seroconverted SARS-CoV-2 without previous 

symptoms (Day > 29)a,b 10 37 74.2% (47.1, 88.6) 

a Serologically converted: positive serology (Non-S protein) test without SARS-CoV-2 positive RT-PCR before positive serology test irrespective of previous symptoms 

b Without previous symptoms: no COVID-19 symptoms occurred before positive serology test at any point during study 
 

AP-38 

Study COV3001:

Additional Analyses 

 Vaccine efficacy by prespecified subgroups 

 Vaccine efficacy by countries with emerging variants 
 

 

AP-39 

Overall VE Against Moderate to Severe/Critical COVID-19 

Consistent Across Prespecified Subgroups 

# Events / N > Day 28 

Per Protocol 

Ad26.COV2.S 

N = 19,630 

Placebo 

N = 19,691 

Moderate to 

Severe/Critical COVID-19 

Vaccine Efficacy 

(95% CI) 

PP Risk Set 113 / 19,306 324 / 19,178 

Age 

65.5% (57.2, 72.4) 

18 – 59 years 87 / 12,617 259 / 12,527 66.8% (57.5, 74.3) 

≥ 60 years 26 / 6,689 65 / 6,651 

Participants with comorbidities (all ages) 

60.4% (36.8, 75.9) 

Yes 44 / 7,684 105 / 7,626 58.6% (40.6, 71.6) 

No 69 / 11,622 219 / 11,552 

Sex 

68.8% (59.0, 76.6) 

Male 54 / 10,764 176 / 10,649 69.8% (58.9, 78.2) 

Female 59 / 8,538 148 / 8,525 

Race and ethnicity 

60.3% (46.0, 71.2) 

Non-Hispanic / Latino 52 / 10,131 163 / 9,957 68.8% (57.2, 77.6) 

Hispanic / Latino 59 / 8,688 153 / 8,741 61.3% (47.4, 71.8) 

White 64 / 11,994 187 / 11,912 66.2% (54.8, 74.9) 

Black 21 / 3,330 66 / 3,300 68.6% (48.0, 81.8) 

-25 0 25 50 75 100 

COV3001; global; non-confirmed: all COVID-19 cases VE% (95% CI) with a positive PCR from any source, regardless of central confirmation 
South Africa 

95% B.1.351 lineage

3% D614G 

Moderate-Severe/Critical 

Severe/Critical 

23 / 2,449 

4 / 2,449 

64 / 2,463 

22 / 2,463 

64.0% (41.2, 78.7) 

81.7% (46.2, 95.4) 

 

 

-25 0 25 50 75 100 

VE% (95% CI) 

 

 

AP-40 

Vaccine Efficacy Consistently High Across 

Key Countries > Day 28 

# Events / N > Day 28 

Vaccine Efficacy 

(95%CI) 

Country 

% Variant Severity 

Ad26.COV2.S 

N = 19,306 

Placebo 

N = 19,178 

United States 

96% D614G 

Moderate-Severe/Critical 32 / 8,958 112 / 8,835 72.0% (58.2, 81.7) 

3% CAL.20C Severe/Critical 1 / 8,958 7 / 8,835 85.9% (-9.4, 99.7) 

Brazil 

69% P.2 lineage 

31% D614G 

Moderate-Severe/Critical 

Severe/Critical 

24 / 3,354 

1 / 3,354 

74 / 3,312 

8 / 3,312 

68.1% (48.8, 80.7) 

87.6% (7.8, 99.7) 

South Africa PP At Risk Set (N = 4,912) Hospitalizations > Day 28*: 0 vs 6 (Ad26.COV2.S vs placebo) 

Full Analysis Set (N = 6,576) COVID-related deaths: 0 vs 5** (Ad26.COV2.S vs placebo) 

COV3001; non-confirmed: all COVID-19 cases with a positive PCR from any source, regardless of central confirmation 

*Sources: MRU (Medical Resource Utilization), SAE, and MA-COV (medical attendance-COV); **6th case excluded due to PCR+ test at baseline 
 

AP-41 

Single Dose of Ad26.COV2.S Offers Substantial

Protection Against COVID-19 

 85% VE* against severe disease 

 Onset of protection as early as 7 days after vaccination 

 Complete protection against COVID-19 related hospitalizations* and deaths 

 66% VE* against moderate to severe disease across all countries 

 Onset evident as early as Day 14, and increased through Day 56 

 72% VE* against moderate to severe COVID-19 in US 

 Study participants reflected the diversity of the overall US population 

 Protection against all symptomatic disease consistent with primary endpoint 

 High-quality, robust data at a time when the incidence of SARS-CoV-2 was increasing, 

and new, highly transmissible variants were emerging 

 High levels of protection consistent across subgroups, countries and regions* 

*> Day 28 
AP-42 

Study COV3001: Safety Results 
 

 

AP-43 

COV3001 Safety Subset Includes Data on Solicited

and Unsolicited Adverse Events 

Received Injection 

N=43,783 

Randomized 

N=44,325 

Ad26.COV2.S 

N=21,895 

N=3,356 (15%) 

Full Analysis Set (FAS) 

Safety Population 

Analysis of SAEs, MAAEs, 

AEs leading to disc., deaths 

Safety Subset 

Analysis of solicited and 

unsolicited AEs 

(N=6,736) 

Placebo 

N=21,888 

N=3,380 (15%) 

Safety analysis cut off date: January 22, 2021 
 

 

 

AP-44 

Safety Data Met FDA Guidelines for Median

Follow-Up of At Least 2 Months 

 Median follow up after vaccination was 58 days 

 Full Analysis Set: 55% had ≥ 2 months of follow-up 

 Safety Subset: nearly all (99.9%) completed post-vaccination 

period of Day 1-29 

COV3001; safety analysis cut off date: January 22, 2021 
AP-45 

Study COV3001:

Solicited Adverse Events 
 

 

100% 

80% 

60% d26.COV2.S 

40% 

20% 

0% 

100% 

80% 

Placebo 60% 

40% 

20% 

0% 

≥ 1 Local AE

Injection Site 

Pain 

Injection Site 

Erythema 

Injection Site 

Swelling 

≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60

Grade 1 

Grade 2 

Grade 3 0.9% 

0.4% 

0.4% 

0.2% 

0.1% 0.2% 0.2% 0.3% 

0.2% 0.2% 0.2% 

0.1% 0.1% 

≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60

 

 

AP-46 

Local Adverse Events, Nearly All Grade 1 and 2 

in Severity, All Events Resolved 2-3 Days After Injection 

A

COV3001; Safety Subset 
 

 

 

 

AP-47 

Systemic Adverse Events Transient with Median

Duration of 1-2 Days 

100% 

80% 

60% 

Ad26.COV2.S 

40% 

20% 

0% 

100% 

80% 

60% 

Placebo 

40% 

20% 

0% 

≥ 1 AE Fatigue Headache Myalgia Nausea Fever 

≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60

Grade 1 

Grade 2 

Grade 3 2.3% 

1.1% 1.2% 

0.8% 

0.9% 

0.4% 

1.4% 

0.1% 

0.2% 0.3% 0.1% 

0.2% 

0.6% 0.7% 

0.2% 0.4% 0.2% 0.3% 

<0.1% 0.1% 0.2% 0.4% 

COV3001; Safety Subset ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60
AP-48 

Study COV3001:

Unsolicited Adverse Events 
AP-49 

Similar Rates of Unsolicited AEs Between Groups 

Ad26.COV2.S Placebo 

Unsolicited Adverse Events n % n % 

Safety Subset N = 3,356 N = 3,380 

Any Adverse Event (AE) 440 13% 407 12% 

Full Analysis Set (FAS) N = 21,895 N = 21,888 

Any Medically-Attended Adverse Event (MAAE) 304 1.4% 408 1.9% 

Any Serious Adverse Event (SAE) 90 0.4% 137 0.6% 

Not COVID-19-related SAE 83 0.4% 96 0.4% 

Any death (reported through January 22, 2021) 3 <0.1% 16 0.1% 

COVID-19 related deaths 0 - 5* -

COV3001; *Excludes PCR+ participant at baseline 
 

AP-50 

Other Adverse Events of Interest 

Ad26.COV2.S Placebo 

Full Analysis Set 

N = 21,895 N = 21,888 

n n 

Hypersensitivity* 77 65 

Venous thromboembolic events** 14 10 

Convulsions 4*** 1 

Tinnitus 6 0 

Peripheral neuropathy 2 2 

Guillain-Barre Syndrome 1 1 

Bell’s Palsy 3 2 

COV3001 

*No anaphylaxis 

**Most participants had relevant predisposing medical conditions and/or other factors 

***Three participants with history of epilepsy, one additional event followed transverse sinus thrombosis 
 

AP-51 

Thrombotic and Thromboembolic Events 

Full Analysis Set 

Ad26.COV2.S 

N = 21,895 

n 

Placebo 

N = 21,888 

n 

Total participants with any event 14 10 

Venous thromboembolic events 

Deep vein thrombosis 

Pulmonary embolism 

Transverse sinus thrombosis 

6 

4 

1 

2 

1 

0 

Thrombosed hemorrhoid 0 1 

11 4 

Arterial thromboembolic events 

Total participants with venous events 

Cerebrovascular events 3* 3 

Cardiovascular events 1 3 

Total participants with arterial events 3 6 

COV3001 

* 2 events occurred in one participant 
AP-52 

Benefits of Ad26.COV2.S Outweigh Known and 

Potential Risks 

 Demonstrated acceptable safety and reactogenicity profile 

 Overall, reactogenicity mild and transient 

 Grade 3 reactogenicity rare 

 Most AEs mild or moderate 

 Generally resolved 1 to 2 days post vaccination 

 Safety further supported by > 193,000 individuals exposed to 

Janssen Ad26-based vaccines 
 

 

AP-53 

COV3001 Protocol Amendment to Facilitate 

Cross-Over of Placebo Participants 

 Upon authorization by a regulatory authority, all placebo 

participants to receive 1 dose of Ad26.COV2.S 

 All participants encouraged to remain in study up to 2 years to 

assess efficacy, safety, immunogenicity 

 Amendment will allow assessment of 

 Duration of protection and immunogenicity of single dose 

by comparing 2 groups vaccinated ~4-6 months apart 
 

AP-54 

Overview of Janssen’s Single-Dose 

COVID-19 Vaccine, Ad26.COV2.S 

Janssen Pharmaceutical Companies 

of Johnson & Johnson 

US Centers for Disease Control and Prevention 

Advisory Committee on Immunization Practices 

February 28, 2021