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Janssen COVID-19 Vaccine

Janssen Pharmaceutical Companies of Johnson & Johnson

Advisory Committee on Immunization Practices

April 23, 2021

Mathai Mammen, MD, PhD

Global Head, Research and Development

Janssen
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• 7.9 million in United States have received Janssen COVID-19 vaccine 

• Vital and important option for many; Uniquely good option for some

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Particular benefits for those who face barriers to healthcare services

Highly protective efficacy against global variants of concern

• Together with health authorities and using various surveillance systems, 

identified very rare side effect: thrombosis with thrombocytopenia

Increased awareness among general public and healthcare professionals

Goal: more identifiable, diagnosable, and treatable 

Important and Unique Benefits of Janssen COVID-19 Vaccine Outweigh 

Risks in Global Effort to Fight COVID-19 
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• Dynamic landscape of COVID-19 pandemic: emerging variants

• Janssen COVID-19 vaccine

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Efficacy

Key attributes 

Characterization of thrombosis with thrombocytopenia

• Balancing benefit and risk

Agenda 
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Jan 22 Apr 30 Aug 8 Nov 16 Feb 24 Apr 15

2020 2021

Daily Deaths

Africa

Oceania

S. 

America

Europe

Asia 

ex China

China

N. 

America

The Global Pandemic Continues: Dynamic Landscape of COVID-19

Data: Source: CDC COVID Tracker Image: adapted from Johns Hopkins University CSSE COVID-19 Data.

US Cases 466,810 Global 4.5 million

Global Not 

Reported

US 

Hospitalizations 38,936

7-Day moving average

US Deaths 4,786 Global > 76,000
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Strong Vaccine Efficacy,

Important Option As Variants Emerge in US

Pivotal Study 3001 (N=44,325) 

85% vaccine efficacy against severe COVID-19 > Day 28 in the United States 

• Protection starts by Day 7, indicating early onset of protection

• 100% protection against COVID-19 related hospitalizations (> Day 28) and deaths 

• Consistent vaccine efficacy against severe disease across all regions

Highly protective against global variants of concern

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

and in Brazil (n > 4,912) where P.2 lineage (69%) is highly prevalent

Ongoing South Africa study supports strong effectiveness in presence of B.1.351

• Open-label healthcare worker study (N=288,368 vaccinated)

• Primarily women (76%), mostly people under 50 years old (75%)

• 4 COVID-19-related deaths (0.001%) (D4, 7, 7, 20) and no deaths post-day 28

• Of 17 (0.006%) COVID-19 breakthrough cases, 3 occurred after Day 28 (D31, 31, 34) 
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B.1.351

South Africa 

Sep 27 Oct 11 Oct 25 Nov 8 Nov 22 Dec 6 Dec 20 Jan 3 Jan 17 Jan 31 Feb 14 Feb 28 Mar 14

2020 2021

0%

40%

20%

60%

80%

100%

Nextstrain, 2021

B.1.351, Which Includes 484 Mutation, Became Dominant

Variant in South Africa in Matter of Weeks

• B.1.351 became nearly only variant circulating in South Africa 8 weeks after first appearance

• Now found in 36 of 50 US states / territories and across Europe

• As with B.1.351, other variants containing the key mutation of position E484K emerging in US
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Single-Dose Vaccine Plays Essential, 

Unique Role in Urgent Effort to Contain Virus

▪ Only authorized COVID-19 vaccine single-dose regimen

▪ Critical option for rural and transient populations

▪ Vaccine efficacy against severe disease seen by Day 7 in pivotal trial

▪ Durable immune response based on platform, early COVID-19 data

▪ Compatible with all existing distribution channels

▪ Stored at normal refrigerator temperatures

▪ Can reach remote locations

1-Dose Vaccine

Early Onset, 

Durable Response

Simple Shipping, 

Storage
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Janssen COVID-19 Vaccine

Janssen Pharmaceutical Companies of Johnson & Johnson

Advisory Committee on Immunization Practices

April 23, 2021

Joanne Waldstreicher, MD

Chief Medical Officer

Johnson & Johnson
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Thrombosis with Thrombocytopenia: 

Post-Authorization Cases Reported after Janssen Vaccine 

Very rare Rare Uncommon Common Very Common

100/1,000,000 1,000/1,000,000 10,000/1,000,000 100,000/1,000,000

1. Cases, # people vaccinated: CDC (April 22)

2. Incidence based on CVST + Thrombocytopenia in 2018 from 5 observational sources (n=63 million persons)

Reported Thrombosis with 

Thrombocytopenia

15 cases/7.98M people 

vaccinated1

1.9 cases/million people
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Thrombosis with Thrombocytopenia: 

Post-Authorization Cases Reported after Janssen Vaccine and Background

Incidence proportion (cases/million people)

Very rare Rare Uncommon Common Very Common

100/1,000,000 1,000/1,000,000 10,000/1,000,000 100,000/1,000,000

Background CVST with 

Thrombocytopenia

0.1/million people2

Reported Thrombosis with 

Thrombocytopenia

15 cases/7.98M people 

vaccinated1

1.9 cases/million people

1. Cases, # people vaccinated: CDC (April 22)

2. Incidence based on CVST + Thrombocytopenia in 2018 from 5 observational sources (n=63 million persons)
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Thrombosis with Thrombocytopenia: 

Post-Authorization Cases Reported after 

Janssen Vaccine and Other Adverse Events

Very rare Rare Uncommon Common Very Common

Incidence proportion (cases/million people)

100/1,000,000 1,000/1,000,000 10,000/1,000,000 100,000/1,000,000

Heparin-induced thrombocytopenia

1,000 - 50,000 7

7. Hogan, M. et al. Vasc Med. 2020. DOI: 10.1177/1358863X19898253. Epub. PMID: 32195628.

Anaphylaxis in any non-COVID 

vaccine

1.2 2

Intussusception in rotavirus 

vaccine

16-69 5-6

Immune thrombocytopenia 

in MMR vaccine

26 4

GBS in H1N1 influenza vaccine 

3.4 3

Reported Thrombosis with 

Thrombocytopenia

15 cases/7.98M people 

vaccinated1

1.9 cases/million people

1. Cases, # people vaccinated: CDC (April 22)

2. McNeil, M. et al. JACI. 2016. http://dx.doi.org/ 137.3.2015.10.1016/j.jaci.2015.07.048

3. Salmon. et al. Lancet. 2013 (IR = IRR*baseline risk = 2.5*1.2/100,000py)

4. Mantadakis, E. J Pediatr. 2010. DOI: 10.1016/j.jpeds.2009.10.015. Epub. PMID: 20097358

5. Rha, B. et al. 2014. DOI: 10.1586/14760584.2014.942223

6. Jiang, J. et al. 2013. https://doi.org/10.1371/journal.pone.0068482
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Thrombosis with Thrombocytopenia: Post-Authorization Cases 

Reported after Janssen Vaccine in Women Age < 50 and Background

Very rare Rare Uncommon Common Very Common

Reporting proportion (cases/million people)

Background CVST with 

Thrombocytopenia

0.1/million people2

Reported Thrombosis with 

Thrombocytopenia

13 cases /1.9M people vaccinated1

7.0 cases/million people

1. Cases, # people vaccinated: CDC (April 22)

2. Background rate in 1JAN2018 from 5 US observational sources (n=63 million persons), * 28/365d (time-at-risk)

100/1,000,000 1,000/1,000,000 10,000/1,000,000 100,000/1,000,000
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Known and Labeled Risks For Combination Oral Contraceptives 

in Women 

Very rare Rare Uncommon Common Very Common

Incidence rate (cases/million person-years)

100/1,000,000 1,000/1,000,000 10,000/1,000,000 100,000/1,000,000

All data from published literature (other than venous thromboembolic events: source is product label)

1. Lidegaard, O. et al. NEJM. 2012

2. Weill, A. et al. BMJ. 2016

3. Azoomegar. et al. Frontiers in Neurology. 2015 (IR=background rate * OR = 0.4/100,000 * 7.59)

4. Yasmin package insert: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7ea6a60-5a56-4f81-b206-9b27b7e58875

Ischemic Stroke

99 - 1622

Myocardial Infarction

37 - 581

Cerebral Venous Sinus 

Thrombosis

303

Venous thromboembolic 

events

300-9004

Thrombotic Stroke

151 - 1561
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Favorable Benefit-Risk Assessment in Adults 18 Years and Older

-6400 -4400 -2400 -400 1600 3600 5600

a. CDC COVID-19 mortality rate as of Apr 14, 2021, 2018 US census population, COV3001 interim analysis assuming 100% efficacy on death for 1-year post-vaccination 

b. CDC COVID-19 hospitalization rate from Mar 7, 2020 – Mar 6, 2021, COV3001 interim analysis assuming 100% efficacy on hospitalization for 1-year post-vaccination 

c. Observed: Reporting proportion; Background: Assumed 0 cases/million

1.9

6,037

Vaccinating 1M adults 18 years and older in the US would be expected to result in:

COVID-19 related deaths a

COVID-19 related hospitalization b

Thrombosis with thrombocytopenia c

# fewer cases per 

1,000,000 individuals

Key Benefits

Key Risks

# additional cases per 

1,000,000 individuals

2,094

Favorable Unfavorable

Number cases per 1,000,000 individuals
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Favorable Benefit-Risk Assessment in Women Age < 50

Vaccinating 1M women age < 50 in the US would be expected to result in:

-6400 -4400 -2400 Number cases per 1,000,000 individuals -400 1600 3600 5600

7.0

2,638

COVID-19 related deaths a

COVID-19 related hospitalization b

Thrombosis with thrombocytopenia c

# additional cases per 

1,000,000 individuals

116

Key Benefits

Key Risks

# fewer cases per 

1,000,000 individuals

Favorable Unfavorable

a. CDC COVID-19 mortality rate as of Apr 14, 2021, 2018 US census population, COV3001 interim analysis assuming 100% efficacy on death for 1-year post-vaccination 

b. CDC COVID-19 hospitalization rate from Mar 7, 2020 – Mar 6, 2021, COV3001 interim analysis assuming 100% efficacy on hospitalization for 1-year post-vaccination 

c. Observed: Reporting proportion; Background: Assumed 0 cases/million
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• Active follow up to identify and investigate cases, understand underlying pathophysiology

• Designed observational study protocols using multiple databases

• Support guidance from CDC and professional societies that outline education, diagnosis and 

treatment

• Implementing HCP and consumer support initiatives; professional initiatives

– Vaccine fact sheets on Janssen healthcare and consumer websites

– 24-hour global hotline

• Agree with FDA on warning in label and alerting vaccinees with communications materials

Janssen Supports Public Awareness, and Guidance for Medical 

Professionals of this Very Rare Event Following Vaccination 
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FDA-agreed Warning and Precaution Regarding Thrombosis with 

Thrombocytopenia

5.2 Thrombosis with Thrombocytopenia

Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use

authorization suggest an increased risk of thrombosis involving the cerebral venous sinuses and

other sites (including but not limited to the large blood vessels of the abdomen and the veins of the

lower extremities) combined with thrombocytopenia and with onset of symptoms approximately

one to two weeks after vaccination [see Overall Safety Summary (6.2)]. Most cases of thrombosis

with thrombocytopenia reported following the Janssen COVID-19 Vaccine have occurred in

females ages 18 through 49 years; some have been fatal. Specific risk factors for thrombosis with

thrombocytopenia following the Janssen COVID-19 Vaccine and the level of potential excess risk

due to vaccination are under investigation. Based on currently available evidence, a causal

relationship between thrombosis with thrombocytopenia and the Janssen COVID-19 Vaccine is

plausible.
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FDA-agreed Warning and Precaution Regarding Thrombosis with 

Thrombocytopenia

5.2 Continued

Healthcare professionals should be alert to the signs and symptoms of thrombosis with

thrombocytopenia in individuals who receive the Janssen COVID-19 Vaccine. The clinical course

shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected

thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine, the use of heparin

may be harmful and alternative treatments may be needed. Consultation with hematology

specialists is strongly recommended. The American Society of Hematology has published

considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia

following the Janssen COVID-19 Vaccine (https://www.hematology.org/covid-19/vaccine-inducedimmune-thrombotic-thrombocytopenia).

Recipients of Janssen COVID-19 Vaccine should be instructed to seek immediate medical attention

if they develop shortness of breath, chest pain, leg swelling, persistent abdominal pain,

neurological symptoms (including severe or persistent headaches or blurred vision), or petechiae

beyond the site of vaccination.
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• Continue to face deadly pandemic, variants making containment more challenging globally

– Janssen COVID-19 vaccine critically important to help halt spread of infection 

• Janssen vaccine offers early and durable efficacy, protection against variants, and simplicity

– Provides access to certain populations that typically face barriers to healthcare services

• Concerns that a restriction would leave significant proportion of the US unvaccinated

– Puts reaching herd immunity at risk

• Janssen committed to understanding and communicating all risks, including very rare events of thrombosis 

with thrombocytopenia

– Supports awareness, education and labeling; making this event more identifiable, diagnosable and 

treatable with improved chances for successful outcomes

• Janssen COVID-19 vaccine central in effort to end pandemic

Benefits of an Effective, Single-Dose, Easy-to-Use 

Janssen COVID-19 Vaccine Continue to Outweigh Risks
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Janssen COVID-19 Vaccine

Janssen Pharmaceutical Companies of Johnson & Johnson

Advisory Committee on Immunization Practices

April 23, 2021