INDICATIONHEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. IMPORTANT SAFETY INFORMATION Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.Please see additional Important Safety Information throughout this brochure and accompanying full Prescribing Information.

THERE IS NO PARTIAL PROTECTION FROM HEPATITIS B

THERE IS NO PARTIAL PROTECTION FROM HEPATITIS B

PROTECTED UNPROTECTED

TRADITIONAL 3-DOSE HEPATITIS B VACCINES MAY CREATE A FALSE SENSE OF SECURITY THAT PUTS PATIENTS, HEALTHCARE PROVIDERS (HCPs), AND INSTITUTIONS AT RISK2,3

10mIU/mL

Anti-HBs 10 mIU/mL is considered a correlate

of vaccine-inducedclinical protection1

You can only be confident of PROTECTIVE IMMUNITY if your anti-HBs threshold is 10 mIU/mL1

The majority of people who do not receive all 3 doses of traditional

hepatitis B vaccines fail to achieve protective immunity2

Abbreviation: Anti-HBs, antibody against hepatitis B surface antigen.

~20%

TO 30%

IN CLINICAL STUDIES, MANY FAILED TO ACHIEVE PROTECTIVE IMMUNITY EVEN AFTER COMPLETING ALL 3 DOSES OF A TRADITIONAL HEPATITIS B VACCINE

~20% to 30% ofpeople failed toachieve protective immunity and remain unprotected6

~35% of people with diabetes failed to achieve protective immunity and remain unprotected6,7

96%FAILED TO ACHIEVE

PROTECTIVE IMMUNITY

FAILED TO ACHIEVE

PROTECTIVE IMMUNITY

FAILED TO ACHIEVE

PROTECTIVE IMMUNITY

73% 18.7%

ENGERIX-B6,8

RISK OF HBV INFECTION REMAINS

Month

Dose

10 2 3 4 5 6 7

1 2 3

~35%

IT TAKES 6 MONTHS TO COMPLETE A TRADITIONAL 3-DOSE HEPATITIS B VACCINE SERIES2

FOR MOST PEOPLE, THE RISK OF INFECTION REMAINS UNTIL AFTER THE THIRD DOSE IS COMPLETED2

TRADITIONAL 3-DOSE HEPATITIS B VACCINES HAVE BEEN PROVEN DIFFICULT TO COMPLETE

of HCPs did not receive all 3 doses4

of adults aged 19+ did not receiveall 3 doses5~40% ~75%

Abbreviation: HBV, hepatitis B virus.

HEPATITIS B INFECTION IS DANGEROUS

~5,500 HBV-RELATED DEATHS OCCUR EACH YEAR IN THE US11

HBV can remain infectious outside the body for at least 7 days9,10

HEPATITIS B CAN HAVE SERIOUS CONSEQUENCES

of hepatocellular carcinomas are caused by HBV11

upto

of cirrhosis diagnoses are

caused by HBV12

50% 15%

HBV 100XHIV9

more infectious than

is

7DAYS

Hepatitis B does not discriminate. It can have a lasting impact on everyone in the healthcare continuum, and it puts patients, HCPs, and institutions at risk.9,10,13,14

EFFECTIVE VACCINATION IS CRITICAL TO REDUCING THE SPREAD OF THE DISEASE2

THERE IS NO CURE FOR HEPATITIS B

HEPATITIS B INFECTION CAN PUT EVERYONE AT RISK

HEPATITIS B VACCINES HAVE BEEN AVAILABLE FOR NEARLY 40 YEARS, YET HBV INFECTIONS ARE ON THE RISE15,16

THE RISK OF POTENTIAL EXPOSURE TO HBV FOR HCPs REMAINS HIGH

MOST INFECTED HCPs COULD NOT RECALL ANY EXPOSURE15

DESPITE THE HIGH RISK FOR HCPs, EXPOSURES OFTEN GO UNREPORTED

HCPs experience 600,000 to 800,000potential exposures each year through needlesticks and contact with bodily fluids13,14

46% of percutaneous exposures among interns, fellows, and residents are not reported to occupational health15

As many as 2.2 million peoplein the US areinfected with hepatitis B17

Estimated new cases of HBV in the US have risen ~11% over a 5-year period16

PROTECT WITH THE ONLY 2-DOSE, 1-MONTH HEPATITIS B VACCINE FOR ADULTS6,18

UNANIMOUSLY RECOMMENDED BY THE ACIP14

FASTER PROTECTION WITH HEPLISAV-B

THERE IS NO PARTIAL PROTECTION FROM HBV

95% of Those Who Received HEPLISAV-B Were Protected After Just 2 Doses in 1 Month6,8*

Percentage of People Aged 18 to 55 Achieving Protective Immunity†TRIAL 1

IMPORTANT SAFETY INFORMATIONAppropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.Please see additional Important Safety Information throughout this brochure and accompanying full Prescribing Information.

• 13.7% difference (95% CI, 10.4 to 17.5) in protective immunity between patient groups at primary endpoint6

• The primary analysis compared the rate of protective immunity at week 12 for HEPLISAV-B with that at week 28 for Engerix-B6

• Statistical significance was met; however, statistical significance was not prespecified in trial 18

• Noninferiority was met because the lower bound of the 95% confidence interval of the difference in SPRs was greater than -10%6

†Protective immunity defined as antibody concentration ≥10 mIU/mL.11*Compared to 81.3% who received 3 doses of Engerix-B.6

2 Months 3 Months 4 Months 5 Months 6 Months 7 Months

TRAIL 1

100

80

60

40

20

0

% o

f peo

ple

achi

evin

g pr

otec

tive

imm

unity

1 Month

95.0% 98.2%

81.3%

Primary endpoint

HEPLISAV-Bmeasured timepoint

Engerix-Bmeasured timepoint

HEPLISAV-B2-dose series (N=1511)

Engerix-B3-dose series (N=521)

32.7%

FASTER AND HIGHER RATES OF PROTECTION WITH HEPLISAV-BHEPLISAV-B Provided Statistically Significantly Higher Rates ofProtection Than Engerix-B at Every Timepoint in Adults Aged 40 to 70 Years6,8

Percentage of People Aged 40 to 70 Achieving Protective Immunity*TRIAL 2

• 19.6% (95% CI, 14.7 to 24.8) difference in protective immunity between patient groups at primary endpoint6,8

• The primary analysis compared the rate of protective immunity at week 12 for HEPLISAV-B with that at week 32 for Engerix-B6

*Protective immunity defined as antibody concentration ≥10 mIU/mL.11

Percentage of People Aged 18 to 70 Achieving Protective Immunity*

HIGHER RATES OF PROTECTION IN HYPORESPONSIVE POPULATIONSHEPLISAV-B Even Provided Statistically Significantly Higher Rates of Protection in Diabetics and Other Known Hyporesponsive Populations6,7

TRIAL 3

IMPORTANT SAFETY INFORMATIONHepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).Please see additional Important Safety Information throughout this brochure and accompanying full Prescribing Information.

Trial 3 study design: A clinical trial in adults aged 18 to 70 years who received HEPLISAV-B (N=4537) or Engerix-B (N=2289). The primary analysis evaluated the noninferiority of the rate of protective immunity at week 28 induced by HEPLISAV-B (n=640) to Engerix-B (n=321) in patients with type 2 diabetes mellitus. A secondary immunogenicity objective was to demonstrate the noninferiority of the rate of protective immunity with HEPLISAV-B at week 24 compared with Engerix-B at week 28 in all subjects and in subgroups defined by age, sex, body mass index (BMI), and smoking status among adults aged 18 to 70 years.7

N=961

N=3353N=6665 N=5434 N=3241 N=2082

HEPLISAV-B

HEPLISAV-B

Engerix-B

Engerix-B

TOTAL TRIAL POPULATION MALE

95.4% 81.3%

94.5% 78.8%

VS VS

PATIENTS WITH DIABETES

OBESITY

65.1%90.0%

94.7% 75.4%

VS

VS

AGED 40 TO 70 SMOKERS

94.6% 78.7%

95.9% 78.6%

VS VS

*Protective immunity defined as antibody concentration ≥10 mIU/mL.11

THERE IS NO PARTIAL PROTECTION FROM HBV

2 Months 3 Months 4 Months 5 Months 6 Months 7 Months 8 Months 9 Months 10 Months 11 Months 12 Months1 Month

TRAIL 2

100

80

60

40

20

0

90.1% 95.1%

21.5%

72.9% 70.5%

HEPLISAV-B2-dose series (N=1121)

Engerix-B3-dose series (N=353)

% o

f peo

ple

achi

evin

g pr

otec

tive

imm

unity

Primary endpoint

HEPLISAV-Bmeasured timepoint

Engerix-Bmeasured timepoint

RATES OF PROTECTION >90% ACROSS 3 STUDY POPULATIONS

TRIAL SUMMARY

Regardless of Patient Type, 2 Doses of HEPLISAV-B in 1 Month Protected >90% of Adults Across 3 Pivotal Trials vs 3 Doses of Engerix-B6

†Subgroups defined by age, sex, body mass index (BMI),and smoking status among adults aged 18 to 70 years.7

Error bars represent 95% confidence intervals

Percentage of People Achieving Protective Immunity*

*Protective immunity defined as antibody concentration ≥10 mIU/mL.11

THERE IS NO PARTIAL PROTECTION FROM HBV

The Advisory Committee on Immunization Practices (ACIP) Recommends the Use of HEPLISAV-B for Protecting Adults at Risk of Hepatitis B Infection18

IMPORTANT SAFETY INFORMATIONDo not administer HEPLISAV-B to individuals with a history of severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.Please see additional Important Safety Information throughout this brochure and accompanying full Prescribing Information.

PROTECT WITH THE ONLY 2-DOSE HEPATITIS B VACCINE AVAILABLE FOR ADULT PATIENTS6,18

3 DOSES IN 6 MONTHS

VS

Engerix-B19

1

4

2

5

3

6

HEPLISAV-B6

2 DOSES 1 MONTH APART

(0.5 mL each)

1

ADMINISTRATION AND STORAGE6

• Administer HEPLISAV-B by intramuscular injectionin the deltoid region

• Store in a refrigerator at 2°C to 8°C (35°F to 46°F)

• Do not freeze• Prefilled syringes are latex-free

% o

f peo

ple

achi

evin

g pr

otec

tive

imm

unity

100

90

80

70

60

50

40

30

20

10

0N=1511

HEPLISAV-B2 doses in 1 month

N=521 N=1121 N=353 N=4376 N=2289

Trial 1:Adults Aged 18 to 55

Trial 2:Adults Aged 40 to 70

Trial 3:Diabetics and Others†

Engerix-B3 doses in 6 months

95.0%

81.3%90.1%

70.5%

95.4%

81.3%

*Redness and swelling ≥2.5 cm. †Oral temperature ≥100.4°F (38.0°C).

Percentage With Local or Systemic Reactions Within 7 Days of Vaccination: Trial 16

Percentage With Local or Systemic Reactions Within 7 Days of Vaccination: Trial 26

HEPLISAV-B Engerix-BPost-Dose: Post-Dose:

REACTION 1 2 1 2 3Local N=1810 N=1798 N=605 N=603 N=598

Injection-Site Pain 38.5% 34.8% 33.6% 24.7% 20.2%

Injection-Site Redness* 4.1% 2.9% 0.5% 1.0% 0.7%

Injection-Site Swelling* 2.3% 1.5% 0.7% 0.5% 0.5%Systemic

Fatigue 17.4% 13.8% 16.7% 11.9% 10.0%

Headache 16.9% 12.8% 19.2% 12.3% 9.5%

Malaise 9.2% 7.6% 8.9% 6.5% 6.4%

N=1784 N=1764 N=596 N=590 N=561

Fever† 1.1% 1.5% 1.8% 1.7% 1.8%

HEPLISAV-B Engerix-BPost-Dose: Post-Dose:

REACTION 1 2 1 2 3Local N=1952 N=1905 N=477 N=464 N=448

Injection-Site Pain 23.7% 22.8% 18.4% 15.9% 13.8%

Injection-Site Redness* 0.9% 0.7% 0.6% 0.2% 0.2%

Injection-Site Swelling* 0.9% 0.6% 0.6% 0.6% 0.2%Systemic

Fatigue 12.6% 10.8% 12.8% 12.1% 9.4%

Headache 11.8% 8.1% 11.9% 9.5% 8.5%

Malaise 7.7% 7.0% 8.6% 7.1% 5.1%

Myalgia 8.5% 6.4% 9.6% 8.0% 4.5%

N=1923 N=1887 N=472 N=459 N=438

Fever† 0.6% 0.6% 0.6% 0.9% 0.7%

Data Derived From the Largest Clinical Trial Safety Database (n=14,238) for a Hepatitis B Vaccine8

SAFETY PROFILE DEMONSTRATED ACROSS TRIALS IN MORE THAN10,000 PATIENTS8

Unsolicited Adverse Events Reported in 3 Pivotal Clinical Trials6

SAFETY PROFILE DEMONSTRATED ACROSS 3 TRIALS WITH 12 MONTHSOF FOLLOW-UP8

*For trial 3, only unsolicited medically attended adverse events, those for which a subject sought medical care, were captured.†For trials 2 and 3, new-onset autoimmune adverse events are listed.

• Herpes zoster was reported in 0.7% of HEPLISAV-B patients and 0.3% of patients receiving Engerix-B

Unsolicited Adverse Events*

Serious Adverse Events

Immune-Mediated Adverse Events

Trial 1 HEPLISAV-B N=1810Within 28 days of any injection

42.0% Within 7 months of the first

vaccine dose

1.5% 0.2%

Engerix-B N=605 41.3% 2.1% 0.7%

Trial 2HEPLISAV-B N=1968 Within 28 days

of any injection

35.4% Within 12 months of the first

vaccine dose

3.9% 0.2%

Engerix-B N=481 36.2% 4.8% 0.0%

Trial 3HEPLISAV-B N=5587

Within 28 days of any injection

20.1% Within 13 months of the first

vaccine dose

6.2% 0.1%

Engerix-B N=2781 20.1% 5.3% 0.0%

Percentage Who Experienced Adverse Events After Vaccination

REFERENCES1. Schillie S, Vellozzi C, Reingold A, et al. Prevention of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018;67(1):1-31. 2. Mast EE, Weinbaum CM, Fiore AE, et al. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: immunization of adults. MMWR Recomm Rep. 2006;55(RR-16):1-33. 3. Louther J, Feldman J, Rivera P, Villa N, DeHovitz J, Sepkowitz KA. Hepatitis B vaccination program at a New York City hospital: seroprevalence, seroconversion, and declination. Am J Infect Control. 1998;26(4):423-427. 4. Immunization and Infectious Diseases. Office of Disease Prevention and Health Promotion website. https://www.healthypeople.gov/2020/data-search/Search-the-Data#objid=4677. Accessed January 7, 2019. 5. Williams WW, Lu PJ, O’Halloran A, et al. Surveillance of vaccination coverage among adult populations - United States, 2015. MMWR Surveill Summ. 2017;66(11):1-28. 6. HEPLISAV-B [package insert]. Berkeley, CA: Dynavax Technologies Corporation; 2017. 7. Jackson S, Lentino J, Kopp J, et al. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine. 2018;36(5):668-674. 8. Dynavax Technologies Corporation. FDA Advisory Committee Briefing Document: HEPLISAV-B™ (Hepatitis B Vaccine [Recombinant], Adjuvanted). Presented at: Meeting of the Vaccines and Related Biological Products Advisory Committee; July 28, 2017; Silver Spring, MD. 9. Walayat S, Ahmed Z, Martin D, Puli S, Cashman M, Dhillon S. Recent advances in vaccination of non-responders to standard dose hepatitis B virus vaccine. World J Hepatol. 2015;7(24):2503-2509. 10. Than TT, Jo E, Todt D, et al. High environmental stability of hepatitis B virus and inactivation requirements for chemical biocides. J Infect Dis. 2018 Oct 24. doi: 10.1093/infdis/jiy620. [Epub ahead of print]. 11. Centers for Disease Control and Prevention. Hepatitis B. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:149-174. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepb.pdf. Accessed October 16, 2017. 12. Starr SP, Raines D. Cirrhosis: diagnosis, management, and prevention. Am Fam Physician. 2011;84(12):1353-1359. 13. American Nurses Association’s Needle Stick Prevention Guide. World Health Organization website. http://www.who.int/occupational_health/activities/2need guide.pdf. Accessed July 18, 2018. 14. Schillie S, Harris A, Link-Gelles R, Romero J, Ward J, Nelson N. Recommendations of the Advisory Committee on Immunization Practices for use of a hepatitis B vaccine with a novel adjuvant. MMWR Morb Mortal Wkly Rep. 2018;67(15):455-458. 15. Schillie S, Murphy TV, Sawyer M, et al. CDC guidance for evaluating health-care personnel for hepatitis B virus protection and for administering postexposure management. MMWR Recomm Rep. 2013;62(RR-10):1-19. 16. Viral hepatitis statistics and surveillance. Centers for Disease Control and Prevention website. https://www.cdc.gov/hepatitis/statistics. Accessed September 28, 2018. 17. Kowdley KV, Wang CC, Welch S, Roberts H, Brosgart CL. Prevalence of chronic hepatitis B among foreign-born persons living in the United States by country of origin. Hepatology. 2012;56(2):422-433. 18. Kim DK, Hunter P; for the Advisory Committee on Immunization Practices. Recommended adult immunization schedule, United States, 2019. Ann Intern Med. 2019;170(3):182-192. 19. Engerix-B [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2015.

THERE IS NO PARTIAL PROTECTION FROM HBV

Please see additional Important Safety Information throughout this brochure and accompanying full Prescribing Information.

Traditional 3-dose hepatitis B vaccines leave many adults

unprotected6,8

HEPLISAV-B protectedmore people quickly with

2 doses in 1 month6,8

HEPLISAV-B protected >90% of adults in head-to-head trials,

regardless of patient type6

FASTER AND HIGHER RATES OF PROTECTION FROM HEPATITIS B6

HeplisavB.com

© 2019 Dynavax Technologies Corporation. All rights reserved. March 2019 US-19-00-00034

IMPORTANT SAFETY INFORMATION Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

ADVOCATE FOR BETTER PROTECTION—FOR YOU, YOUR COLLEAGUES, YOUR PATIENTS, AND YOUR INSTITUTION

INDICATIONHEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

Please see additional Important Safety Information throughout this brochure and accompanying full Prescribing Information.Engerix-B is a registered trademark of the GSK group of companies.