National Center for HIV, Viral Hepatitis, STD, and TB Prevention

Universal Adult Hepatitis B Vaccination:

Work Group Considerations

Division of Viral Hepatitis

LCDR Mark K. Weng, MD, MSc, FAAP

Hepatitis Vaccines Work Group, Advisory Committee on Immunization Practices

November 3, 2021
2

 20,700 estimated acute HBV infections each year

(95% CI: 11,800–50,800)1

 > $1 billion spent on hepatitis B-related hospitalizations each 

year (not including indirect costs)2

Hepatitis B in the US

1) https://www.cdc.gov/hepatitis/statistics/2019surveillance/HepB.htm; 2) Corte et al. J Gastroenterol Hepatol. 2014.
3

 1.89 million persons living with chronic HBV (modeled 

estimate; range, 1.49–2.40 million)2

 15-25% risk of premature death from cirrhosis or liver cancer 

among people living with chronic HBV infection3

Hepatitis B in the US

1) Wong et al. Am J Med. 2021 3) https://www.cdc.gov/std/treatment-guidelines/hbv.htm
Simplify a complex adult HepB vaccination schedule

• All infants

• Unvaccinated children aged <19 years

• Persons at risk for infection by sexual exposure

• Sex partners of hepatitis B surface antigen (HBsAg)–positive persons

• Sexually active persons who are not in a long-term, mutually monogamous relationship 

(e.g., persons with more than one sex partner during the previous 6 months)

• Persons seeking evaluation or treatment for a sexually transmitted infection

• Men who have sex with men

• Persons at risk for infection by percutaneous or mucosal exposure to blood

• Current or recent injection-drug users

• Household contacts of HBsAg-positive persons

• Residents and staff of facilities for developmentally disabled persons

• Health care and public safety personnel with reasonably anticipated risk for exposure to 

blood or blood-contaminated body fluids

• Hemodialysis patients and predialysis, peritoneal dialysis, and home dialysis patients

• Persons with diabetes aged 19–59 years; persons with diabetes aged ≥60 years at the 

discretion of the treating clinician

• Others

• International travelers to countries with high or intermediate levels of endemic hepatitis 

B virus (HBV) infection (HBsAg prevalence of ≥2%)

• Persons with hepatitis C virus infection

• Persons with chronic liver disease (including, but not limited to, persons with cirrhosis, 

fatty liver disease, alcoholic liver disease, autoimmune hepatitis, and an alanine 

aminotransferase [ALT] or aspartate aminotransferase [AST] level greater than twice the 

upper limit of normal)

• Persons with HIV infection

• Incarcerated persons

•All other persons seeking protection from HBV infection

• All infants [No change]

• Unvaccinated children aged <19 years [No change]

All adults previously unvaccinated for hepatitis B 

should receive hepatitis B vaccination

Existing Recommendations New Recommendations (Proposed)

Persons recommended to receive hepatitis B vaccination

Schillie et al, 2018
5

HepB Immunization Strategy Evolves Incidence, Hepatitis B

Year HepB Recommendations and Est. Acute Hepatitis B Cases in the US, 1980─2019

Source: National Notifiable Diseases Surveillance System (NNDSS)
6

 Initial decreases in new hep B infections plateaued 10 years ago

 Rates are now highest among adults

 Rates have increased among adults >40 years of age

Risk-based hepatitis B immunization among adults: 

a partial success
7

Hepatitis B vaccine coverage (≥3 doses) among adults aged ≥19 years*

30.0

38.9

33

67.2

33

15.3

0

10

20

30

40

50

60

70

80

90

100

Overall Travelers Chronic liver

conditions

Health care

personnel**

Diabetes

(19-59 years)

Diabetes (>60

years)

Percentage

* for adults with diabetes categories: 19-59 years and 60+ years

**Refers to health care personnel (HCP) overall; 75.3% 

vaccination rate among HCP with direct patient care; 50.9% 

among HCP without direct patient care 7

National Health Interview Survey (NHIS) – US, 2018

Lu et al. Vaccination Coverage Among Adults in the United States, National Health 

Interview Survey, 2018. 2021 May 14;70(3):1-26. Surveillance of Vaccination 

Coverage Among Adult Populations -United States, 2018 - PubMed (nih.gov)
8

57.1

95% CI (53.7-60.4) 48.3

(45.3-51.3)

38.2

(35.2-41.2) 30.1

(27.6-32.8)

19.5

(18.0-21.1)

0

10

20

30

40

50

60

70

80

90

100

19-29 30-39 40-49 50-59 60+

Percentage

8 *Risk Factors: Diabetic, has chronic liver disease, OR traveled to HBV endemic country

Lu et al. National Health Interview Survey, 2018. Unpublished 2021.

Age (years)

HepB vaccination coverage decreased in older-aged adults 

with ≥1 risk factor*
9

Limitations of risk-based approach

Availability of information regarding risk behaviors or exposures 

associated with reported cases of acute hepatitis B virus infection 

— US, 2019

2/3 of reported cases 

were either missing 

risk data or reported 

no identified risk

Source: https://www.cdc.gov/hepatitis/statistics/2019surveillance/index.htm
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Health equity: Disparities could be reduced with a 

universal adult HepB recommendation

 Rates of HBV infection for children and adolescents of all races/ethnicities converged to a 

lower rate when a universal vaccination strategy was implemented for children ≤18y. 1, 2

 Current rates among Black American adults are now up to 3x those of Asian/Pacific 

Islander and Hispanic groups.1

 Racial/ethnic disparities remain in hepatitis B virus infections

Rates of reported

acute hepatitis B

virus infections, by

race/ ethnicity —

United States, 

2004–2019

1. https://www.cdc.gov/hepatitis/stati

stics/2019surveillance/HepB.htm

2. Wasley et al. MMWR. 2008

3. Harris et al. MMWR. 2016
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Health equity: Disparities could be reduced with a 

universal adult HepB recommendation

Risk-based recommendations favor individuals with: 

 Consistent access to preventive health services

 Trust to disclose potentially stigmatizing risk factor(s) 

 Awareness of risk (e.g., infected household contact or sex partner)

 Health literacy
ACIP Hepatitis Work Group: 

Responses to Committee Comments from Prior ACIP Meetings

1. Can universal recommendations increase vaccine 

uptake among people with risk factors?

2. Is a universal HepB vaccination recommendation an 

effective use of resources?

3. Should the proposed HepB recommendation include 

adults of all ages? 

• Compare with adding an upper age limit at ≤59 years and resuming 

the existing risk-based recommendation for persons >59 years
1. Can universal recommendations increase vaccine 

uptake among people with risk factors?

Risk-based Cohort “Universal” Cohort

Vaccine

Date of relevant recommendation

Coverage

(95% CI)

Coverage

(95% CI)

Flu

2010

25–64y +high risk 

conditions1

2009-10 season

28.6%

(±1.1)

51.0%

(± 1.4)

18−64 years +high risk conditions1

2020-21 season

Pneumococcal

2012

19−64y at increased 

risk2

2018

23.3%

(22.0-24.6)

69.0%

(67.5-70.4)

≥65y2

2018

HepB-BD

2005

Newborns3

1/2003 – 6/2005 50.1%

(±1.1)

79.6%

(78-81)

birth year 20184

1CDC FluVaxView

2 NHIS 2018. NHIS captures “any” pneumococcal vaccination; risk-based recommendation includes 

groups with different pneumococcal recommendations.

3 Allred, NJ et al CDC MMWR 2008. Birth Dose, to 3 days from birth

4 CDC ChildVaxView, HepB Birth Dose by Age 0-3 Days 
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Advantages

 Patient: Reduce stigma, barriers

• Remove need to disclose risk factors

 Provider: Simpler recommendation; 

easier implementation

 Practice: Eliminate hepatitis B 

nationally and globally

 Advance health equity goals

Limitations

 Level of future increased vaccine 

uptake is not known

 However, can infer magnitude from 

public health experience with other 

vaccines

1. Can universal recommendations increase vaccine 

uptake among people with risk factors? Yes.
15

In a WG straw poll, 

100% said “Yes”

1. Can universal recommendations increase vaccine 

uptake among people with risk factors?
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 ICER: $153,000 per QALY gained1

• ICER decreases as coverage improves in groups at higher risk*

 Conservative economic model was presented, estimating health 

improvements from universal adult HepB vaccination

• Reduce acute HBV infections by 24%

• Reduce HBV-related deaths by 23% 

1Hall et al, ACIP Presentation, Feb 2021. Assumptions: 3-dose vaccine; base case summary input of~30% coverage (based on 35.8% 

protected, with varying age-group specific coverages among people with risk factors; 50% vaccination coverage in general population)

*With 20% additional coverage in high-risk groups, the $/QALY was $135,000, illustrating the benefits of increased access

2. Is a universal HepB vaccination 

recommendation an effective use of resources?
17

In a WG straw poll, 

70% said “Yes”

30% said “Probably Yes”

2. Is a universal HepB vaccination recommendation 

an effective use of resources?
18

1 Hall et al 2021. Single model run applied to age ≤59y 2Assumptions: 3-dose vaccine, base case: 50% vaccination coverage in general population; ~30% coverage (summary input based on 

35.8% protected, with varying age-group specific coverages ) among people with risk factors

Subanalysis1 (≤59y) Base Case2 (all adults)

ICER per QALY gained $117,000 $153,000

Total incremental cost (2019 USD) ~$22 billion ~$32 billion

NNV to avert an acute infection 271 372

Doses given 298 million 352 million

Increase persons protected by 61% 89%

Reduce acute HBV infections by 23% 24%

3. Should the proposed recommendation include adults of all ages?

vs. including an upper age limit at ≤59 years
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Advantages

 HBV can still cause significant disease in 

adults >59y

• Many adults will acquire risk factors as they 

age (diabetes, renal disease)

• Immunize before acquiring comorbidities that 

reduce response

 Simplified implementation is likely to 

be followed by patients, providers

 Improve health equity across all ages

Limitations

 Lower incidence among age >59y 

(higher ICER for older populations)

 Improved specificity with age limit

• Risk-based recommendation still needed 

for adults >59y

 Difficult to pinpoint future vaccine 

uptake

3. Should the proposed recommendation include adults of all ages?

vs. including an upper age limit at ≤59 years
20

In a WG straw poll, 

56% felt an age cut-off should 

NOT be applied

3. Should the proposed recommendation include all ages?

vs. including an upper age limit at ≤59 years

• One-time HepB completion gives lifetime protection

• Mitigate dynamic risk

• Decreasing immune response at upper extremes of age
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WG Summary

Preferred Adult HepB Recommendation

Universal 100% Current 

risk-based

0%
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WG Summary: 

HHS and NASEM1 have called for viral hepatitis elimination

 Evidence supports where universal recommendations are preferred 

over risk-based vaccination approaches

 More vaccine tools available than when risk-based policy was first 

recommended

• Two 3-dose monovalent vaccines are available; safe, effective with long-term immunogenicity (>35 y)

• One 2-dose vaccine is available; safe and effective

• One vaccine in the pipeline

 Universal hepatitis B vaccination recommendation among adults would 

provide best chance of achieving HBV elimination goals

1. National Academies of Science, Engineering, and Medicine. https://www.nationalacademies.org/our-work/a-national-strategy-for-the-elimination-of-hepatitis-b-and-c
Proposed Recommendation

All adults previously unvaccinated for hepatitis B 

should receive hepatitis B vaccination.
Thank you

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The findings and conclusions in this report are those of the authors and do not necessarily represent the official 

position of the Centers for Disease Control and Prevention.