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ACIP Evidence to Recommendations for a Universal Hepatitis B (HepB) Vaccination Strategy in Adults						Print
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										**Question:**Should all previously hepatitis B (HepB)-unvaccinated adults receive HepB vaccination?
**Population:** Previously HepB-unvaccinated adults age ≥ 18 years
**Intervention:** Universal HepB vaccination strategy (2- and 3-dose schedules)
**Comparison(s):**  Current risk based recommendation
**Outcomes:**
Incidence of hepatitis B
Morbidity related to hepatitis B
Mortality related to hepatitis B
Serious adverse events associated with the 2-dose vaccine** This outcome was solely aimed at assessing the 2-dose HepB-CpG (Heplisav-B, FDA-approved in 2017). The 3-dose, single-antigen HepB vaccines had already been evaluated for their adverse events profiles and had undergone post-licensure assessment.**Background:**Since hepatitis B (HepB) vaccine introduction in 1982, there have been substantial declines in reported hepatitis B cases.  However, despite reductions in hepatitis B incidence achieved through incremental HepB vaccine policy over the past four decades, from a high of 26,654 reported cases (172,700 estimated) in 1985 to a low of 2,791 reported cases (18,100 estimated) in 2014, progress has stalled in further reducing hepatitis B incidence1. In 2018, the reported HepB vaccination coverage (≥3 doses) was overall 30.0% for adults ≥19 years old, demonstrating small increases in coverage throughout the past four decades2, including low coverage among persons in recommended risk groups (e.g., 33% coverage among persons with chronic liver disease).
Acute cases have been rising over the past decade among persons age >40 years, particularly among persons aged 40-49 years (2.7 reported cases per 100,000 population), and persons aged 50-59 years (1.6 reported cases per 100,000 population). This is consistent with low coverage among disproportionately affected populations in this age group (e.g., persons who inject drugs, persons at risk of sexual transmission). In 1991, all U.S. infants were recommended for HepB vaccination3. In 1999, all US children and adolescents through age 18 years who have not received Hep B vaccine were added to the HepB recommendations3.Problem
Problem
Criteria
Work Group Judgements
Evidence
Additional Information**Is the problem of public health importance?**
Yes
**The burden of chronic hepatitis B virus (HBV) disease in the US remains substantial.1-4**
3,192 acute hepatitis B cases reported to CDC in 2019
An estimated 20,700 infections occurred (95% CI: 11,800–50,800)**Limited availability of information regarding risk behaviors or exposures associated with reported cases of acute HBV infection — US, 20194**
33.1% of reported cases had risk factor identified
37.1% of reported cases had risk factor data missing
29.9% of reported cases had no risk factor identified
**Chronic HBV infection develops in5:**
90% of persons infected during infancy
<1 -12% of persons infected during adulthood (more frequently among immunosuppressed, persons with diabetes)
**Chronic HBV infection leads to 15-25% risk for premature death from cirrhosis or liver cancer6**
**Missed opportunities in HepB vaccination coverage among adults ≥19 years7**
2018 National Health Interview Survey: HepB vaccination coverage (>3 doses)
40.3% for adults 19-49 years
19.1% for adults >50 years
**Age, % vaccinated, (95% CI) with 1+ risk factors reported8:**
Age 19-29            57.1        (53.7-60.4)
Age 30-39            48.3        (45.3-51.3)
Age 40-49            38.2        (35.2-41.2)
Age 50-59            30.1        (27.6-32.8)
Age 60+               19.5        (18.0-21.1)
Risk groups likely represent a substantial proportion of the adult population (e.g., people with diabetes, healthcare personnel), but have had low vaccination coverage6.
87% of individuals > 60 years with diabetes were unvaccinated9.
More than 50% of women with 1+ risk factor who visited or talked to a health professional in the past year were unvaccinated10.
HHS Target Measure: Reduce acute HBV infections 90% by 203011Benefits and Harms
Benefits and Harms
Criteria
Work Group Judgements
Evidence
Additional Information**How substantial are the desirable anticipated effects?**
Large
**Seroprotection**
>90% protection among healthy adults who complete the 3-dose HepB series1-4
Estimated ≥90% of persons had evidence of protection 30 years after receiving the primary series1,5**Vaccine effectiveness**
Within 10 years of initiation of universal HepB vaccination in 1991, a 68% decrease in HBV infection prevalence among children was observed6.
No published studies on universal HepB vaccination among adults
**Outcomes averted over cohort lifetime7***
Number averted (% additional averted):
Acute HBV infections
428,485 (24.8%)
Chronic HBV infections
34,200 (24.2%)
Hepatitis B-related deaths
78,808 (22.8%)
Hepatocellular carcinoma
59,477 (28.8%)
*Assumes a 3-dose strategy base case, averting additional hepatitis B-related outcomes compared with baseline current risk-based strategy. Analytic horizon is the lifetime of the cohort, (on average, ~35 years per person).
**Vaccinate general population before chronic liver disease (CLD) and other comorbidities (e.g., obesity, diabetes) develop.**
Patients with CLD are known to have decreased immunogenicity with the conventional (3-dose) vaccine8, 9.
Only 64% of patients with CLD developed immunity with HepB vaccine, in contrast to 90% reported in healthy volunteers in their registration trial.
Lower seroprotection rates (45%) among persons with cirrhosis**How substantial are the undesirable anticipated effects?**
Minimal
**Rare side effects/adverse reactions1,2**
Commonly reported mild adverse events: injection site pain (3-29%), erythema (3%), swelling (3%), fever (1%–6%), and headache (3%)1,3
Estimated incidence of anaphylaxis among vaccine recipients is 1.1 per million doses. Likely causal relationship among yeast-sensitive persons.
Vaccine Safety Datalink (VSD): Over the 7-year study period, after the administration of 876,209 HepA and HepB vaccines; no deaths were reported in the 0-to-30-day window after vaccination3.
Vaccine Adverse Event Reporting System (VAERS) 2005-2015: 2,365 reports in adults, 15 deaths, 139 serious reports including general disorders/ administration site conditions, musculoskeletal conditions and connective tissue disorders, and central nervous system disorders2**HepB-CpG vaccine (Heplisav-B):**minimal mild and severe adverse events (see the accompanying GRADE tables)
**Pregnancy**
VSD study: HepB vaccines administered in 1,399 pregnancies: showed no increased risk of adverse events among pregnant women or their children5
Insufficient data available on HepB-CpG (Heplisav-B) administered during pregnancy3
Heplisav-B Pregnancy Registry:
Ongoing pregnancy registry: collecting information from 250-300 pregnant people on outcomes following pregnancy exposure to Heplisav-B (completion date: August 9, 2023)7Do the desirable effects outweigh the undesirable effects?
Favors intervention
The benefits were judged by the Work Group to accrue to people both with and without risk factors, with nonsignificant harm to both groups on a population level.
For people with risk factors, the benefits are detailed above.
For people without risk factors, this might include people for whom risk factors are difficult to assess, or might eventually develop one of the numerous risk factors for hepatitis B.What is the overall certainty of this evidence for the critical outcomes?
Effectiveness of the intervention:
No studies found
Safety of the intervention:
Moderate
No published empirical evidence was available on coverage among risk groups following a change to a universal or age-based HepB adult recommendation.
Regarding safety, please refer to GRADE evidence profiles for detailed assessment of the certainty of the evidence.Values
Values
Criteria
Work Group Judgements
Evidence
Additional InformationDoes the target population feel that the desirable effects are large relative to undesirable effects?
Probably yes
**Values and preferences vary by risk status/group**
Among adult patients in high-risk settings, 47% did not respond to questions about risk factors for hepatitis B but expressed interest in getting vaccinated.1**Work Group felt that “All other persons seeking protection from HBV infection” is an insufficient recommendation.**
**Puts the burden on the patient to request vaccination, and a universal recommendation might empower the provider to proactively offer vaccine.**Is there important uncertainty about or variability in how much people value the main outcomes?
Probably not important uncertainty or variability
**Limited information on persons with lower risks**
Systematic review of perceptions of immigrants and refugees (mostly Southeast Asians) from highly hepatitis B endemic areas residing in low hepatitis B endemic countries (US, Canada, Australia) found that 54-96% of participants knew that hepatitis B was vaccine-preventable and found differing attitudes toward vaccination2.
In a convenience sample of Vietnamese American immigrant adults, participants were not worried about HBV infection or liver cancer. However, they stated that they would not worry about liver disease after getting vaccinated3.Acceptability
Acceptability
Criteria
Work Group Judgements
Evidence
Additional InformationIs the intervention acceptable to key stakeholders?
Probably yes
Yes
(Work Group split between probably yes/ yes)
**Stakeholder support for universal adult HepB vaccine recommendation and improving adult immunization rates1-5**
State stakeholders expressed willingness to invest in a HepB vaccination program for adults at increased risk.**A national provider survey assessed adult HepB vaccination practices among 433 family medicine physicians and 420 internists in the US6**
68% of providers felt that patients were not willing to disclose high risk behaviors, and nearly 45% of providers reported that they were feeling too pressed for time to routinely assess patients for risk factors.
Nearly 65% of providers said that lack of adequate reimbursement for vaccination and up-front cost of purchasing the vaccine was not a barrier.
**Physicians report that the main barriers to stocking and administering adult HepB vaccines were financial**
In a survey of physicians, 40-60% of internists and family medicine physicians reported assessing the need for HepB vaccine and 65-80% reported stocking HepB vaccines7.
Simplifying HepB vaccine recommendations may encourage practitioners to administer HepB vaccines to adults.
A national provider survey demonstrated that patient and provider concerns about vaccine SAFETY were not substantial barriers to vaccinate.6Resource Use
Resource Use
Criteria
Work Group Judgements
Evidence
Additional InformationIs the intervention a reasonable and efficient allocation of resources?
Yes
A cost utility analysis compared current vaccination recommendations with either 3-dose or 2-dose universal HepB vaccination (intervention strategies). Results were similar for both the 3-dose and 2-dose strategies. In both strategies, universal HepB vaccination improved health and increased costs. For brevity, results from the 3-dose strategy are summarized in the subsequent paragraph, followed by a summary of a 2-dose strategy:
The analysis found universal adult HepB vaccination increased protected persons by 21%, reduced acute HBV infections by 24%, reduced HepB-related deaths by 23% and cost $153,000 per QALY gained with NNV to avert an acute infection equal to 372. When additional high-risk individuals were vaccinated, the expected cost per QALY gained decreased to $137,000 and NNV decreased to 334.
2-dose strategy summary
ICER (USD/QALY)               $122,208
Total incremental cost      (~$57 billion, 2019 USD)
NNV (acute infection)        324
In the base case, the model conservatively assumed that no additional high-risk individuals would be vaccinated following the intervention. When this assumption was relaxed, allowing 20% additional vaccinations to occur in high-risk groups, the cost per QALY and the NNV to avert a case both declined.
In an age-based analysis, the estimated costs per QALY increased at older ages, primarily due to lower incidence levels at older ages.
**Limitations**
Incidence uncertainty
Effects on health equity, stigma are difficult to measure
Future vaccine coverage and completion rates are unknownEquity
Equity
Criteria
Work Group Judgements
Evidence
Additional InformationWhat would be the impact on health equity?
Increased
**Racial disparity in HBV infection rates showed slow improvement**
In 2006, HBV infections rates among non-Hispanic Black people remained over twice as high as among other racial/ethnic populations.1
Recent rates among Black Americans are now up to 3x those of other racial/ethnic minority groups.
Recently, HBV infection rates have increased among non-Hispanic White people.2, 3, 4
Rates of hepatitis B disease for children and adolescents of all races converged to a lower rate after a universal vaccination strategy was implemented for this group.1,3**Risk factors assessed include socio-structural factors that may criminalize and stigmatize5**
A universal vaccination recommendation could eliminate the need for risk factor assessment prior to vaccination and reduce stigma among people who have been marginalized and who are at increased risk, and immigrants with concerns about stigma associated with hepatitis B-related care.9, 10,11
**Estimated proportion of adults aged ≥19 years who received HepB vaccination, by age group, race/ethnicity (NHIS 2018)**
N=9,479*Race, % (95% CI)*
White, 43.6 (41.8, 45.4)
Black, 35.4 (31.4, 39.6)¶
Hispanic, 33.1 (30.1, 3, 6.2)¶
Asian, 45.2 (40.1, 50.4)
Other, 37.8 (31.2, 44.8)¶ p<0.05 by t–test for comparisons with white as the reference.
In the ongoing opioid crisis2, stigma associated with drug use may keep people from reporting risk factors to their clinicians5. Health care providers may rely on self-reported vaccine history to determine need for vaccination, but self-reported vaccination history does not predict immunity well6,7,8.Feasibility
Feasibility
Criteria
Work Group Judgements
Evidence
Additional InformationIs the intervention feasible to implement?
Yes
Adding universal HepB recommendation to the recommended adult schedule can be implemented with the existing adult vaccine infrastructure.
The universal HepB recommendation will be simpler to implement than the current risk-based strategy.
Implementation will require integration with CDC hepatitis B screening/testing guidelines, which are concurrently being updated by a parallel CDC process.Balance of consequences
Desirable consequences *clearly outweigh* undesirable consequences in most settings.
Is there sufficient information to move forward with a recommendation? Yes.
Policy options for ACIP consideration
ACIP recommends the intervention
Final deliberation and decision by the ACIP
Final ACIP recommendation
ACIP recommends the intervention.
Conclusion
Based on the Evidence to Recommendation Framework, the ACIP voted on November 3, 2021 as follows:
The following groups should receive HepB vaccine:
Adults aged 19 through 59 years
Adults aged 60 years and older with risk factors for hepatitis BThe following group may receive HepB vaccines:
Adults aged 60 years and older without known risk factors for hepatitis BReferences
Background:
2019 Viral Hepatitis Surveillance Report. 2021, Centers for Disease Control and Prevention.
Lu, P.J., et al., Surveillance of Vaccination Coverage Among Adult Populations -United States, 2018. MMWR Surveill Summ, 2021. 70(3): p. 1-26.
National Notifiable Diseases Surveillance System (NNDSS). www.cdc.gov/nndss/index.html.Problem:
Roberts, H., D. Kruszon-Moran, K. N. Ly, E. Hughes, K. Iqbal, R. B. Jiles and S. D. Holmberg (2016). “Prevalence of chronic hepatitis B virus (HBV) infection in U.S. households: National Health and Nutrition Examination Survey (NHANES), 1988-2012.” Hepatology 63(2): 388-397.
Lim, J. K., M. H. Nguyen, W. R. Kim, R. Gish, P. Perumalswami and I. M. Jacobson (2020). “Prevalence of Chronic Hepatitis B Virus Infection in the United States.” Official journal of the American College of Gastroenterology | ACG 115(9): 1429-1438.
Wong RJ, Brosgart CL, Welch S, Block T, Chen M, Cohen C, Kim WR, Kowdley KV, Lok AS, Tsai N, Ward J, Wong SS, Gish RG. An Updated Assessment of Chronic Hepatitis B Prevalence Among Foreign-Born Persons Living in the United States. Hepatology. 2021 Aug;74(2):607-626. doi: 10.1002/hep.31782. Epub 2021 May 26.
2019 CDC Hepatitis Surveillance Report. www.cdc.gov/hepatitis/statistics/2019surveillance/HepB.htm
Hyams KC. Risks of chronicity following acute hepatitis B virus infection: a review. Clin Infect Dis. 1995 Apr;20(4):992-1000. doi: 10.1093/clinids/20.4.992. PMID: 7795104.
Hepatitis B Virus (HBV) Infection. Sexually Transmitted Infections Treatment Guidelines, 2021. www.cdc.gov/std/treatment-guidelines/hbv.htm
Ladak, F., A. Gjelsvik, E. Feller, S. R. Rosenthal and B. T. Montague (2012). “Hepatitis B in the United States: ongoing missed opportunities for hepatitis B vaccination, evidence from the Behavioral Risk Factor Surveillance Survey, 2007.” Infection 40(4): 405-413.
CDC unpublished, NHIS 2018.
Hyer, R. N. and R. S. Janssen (2018). “HBSAG-1018, a two-dose hepatitis b vaccine, is well tolerated and effective in diabetic patients aged 60 years or older.” Diabetes 67 (Supplement 1): LB60.
Miller-Handley, H., G. Paulsen, D. Hooper, D. Lazear, M. Lake and L. Danziger-Isakov (2016). “Durability of the hepatitis B seroprotection in pediatric renal transplant recipients.” Open Forum Infectious Diseases. Conference: ID Week 3(Supplement 1).
Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination 2021-2025 (Viral Hepatitis Plan or Plan), January 7, 2021. https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/index.htmlBenefits:
Assad S, Francis A. Over a decade of experience with a yeast recombinant hepatitis B vaccine. Vaccine. 1999 Aug 20;18(1-2):57-67. doi: 10.1016/s0264-410x(99)00179-6. PMID: 10501235.
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André FE. Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine. Am J Med. 1989 Sep 4;87(3A):14S-20S. doi: 10.1016/0002-9343(89)90525-1. PMID: 2528292.
Schillie, S., A. Harris, R. Link-Gelles, J. Romero, J. Ward and N. Nelson (2018). “Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant.” MMWR – Morbidity & Mortality Weekly Report 67(15): 455-458.
Bruce, M. G., D. Bruden, D. Hurlburt, C. Zanis, G. Thompson, L. Rea, M. Toomey, L. Townshend-Bulson, K. Rudolph, L. Bulkow, P. R. Spradling, R. Baum, T. Hennessy and B. J. McMahon (2016). “Antibody Levels and Protection After Hepatitis B Vaccine: Results of a 30-Year Follow-up Study and Response to a Booster Dose.” Journal of Infectious Diseases 214(1): 16-22.
Nelson, N. P., P. J. Easterbrook and B. J. McMahon (2016). “Epidemiology of Hepatitis B Virus Infection and Impact of Vaccination on Disease.” Clinics in Liver Disease 20(4): 607-628.
Hall, Eric. “Economic Evaluation of Universal Hepatitis B Vaccination Among Adults.” Presented to ACIP February 23, 2021.
Roni, D.A., et al., Safety and Efficacy of Hepatitis B Vaccination in Cirrhosis of Liver. Advances in Virology, 2013. 2013: p. 196704.
Moreno-Fernandez, J., J. A. Garcia-Seco, E. M. O. Rodrigo, A. M. S. Segura, F. Garcia-Seco and J. R. Munoz-Rodriguez (2020). “Vaccination adherence to influenza, pneumococcal and hepatitis B virus in adult type 1 diabetes mellitus patients.” Primary care diabetes 14(4): 343-348.Harms:
Assad S, Francis A. Over a decade of experience with a yeast recombinant hepatitis B vaccine. Vaccine. 1999 Aug 20;18(1-2):57-67. doi: 10.1016/s0264-410x(99)00179-6. PMID: 10501235.
Haber, P., P. L. Moro, C. Ng, P. W. Lewis, B. Hibbs, S. F. Schillie, N. P. Nelson, R. Li, B. Stewart and M. V. Cano (2018). “Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015.” Vaccine 36(4): 559-564.
Schillie, S., A. Harris, R. Link-Gelles, J. Romero, J. Ward and N. Nelson (2018). “Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant.” MMWR – Morbidity & Mortality Weekly Report 67(15): 455-458.
McCarthy, N. L., J. Gee, L. Sukumaran, E. Weintraub, J. Duffy, E. O. Kharbanda, R. Baxter, S. Irving, J. King, M. F. Daley, R. Hechter and M. M. McNeil (2016). “Vaccination and 30-day mortality risk in children, adolescents, and young adults.” Pediatrics 137 (3) (no pagination)(e20152970).
Groom, H. C., S. A. Irving, P. Koppolu, N. Smith, G. Vazquez-Benitez, E. O. Kharbanda, M. F. Daley, J. G. Donahue, D. Getahun, L. A. Jackson, A. Tse Kawai, N. P. Klein, N. L. McCarthy, J. D. Nordin, L. Sukumaran and A. L. Naleway (2018). “Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study.” Vaccine 36(41): 6111-6116.Values:
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Owiti, J. A., T. Greenhalgh, L. Sweeney, G. R. Foster and K. S. Bhui (2015). “Illness perceptions and explanatory models of viral hepatitis B & C among immigrants and refugees: a narrative systematic review.” BMC Public Health 15(1): 151.
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Schiff, E. R., B. A. Connor, J. H. Hershey, M. C. Mahoney and W. Schaffner (2007). “Recommendations from a national conference on universal vaccination against hepatitis B and hepatitis A in adults.” Journal of Applied Research 7(1): 3-16.
Schaffner, William. Time for a bold advance to defeat hepatitis B | The Hill. The Hill, 2021 April 30. https://thehill.com/opinion/healthcare/551192-time-for-a-bold-advance-to-defeat-hepatitis-b
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Daley, M. F., K. A. Hennessey, C. M. Weinbaum, S. Stokley, L. P. Hurley, L. A. Crane, B. L. Beaty, J. C. Barrow, C. I. Babbel, L. M. Dickinson and A. Kempe (2009). “Physician practices regarding adult hepatitis B vaccination: a national survey.” Am J Prev Med 36(6): 491-496.
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Hall, Eric. “Economic Evaluation of Universal Hepatitis B Vaccination Among Adults.” Presented to ACIP February 23, 2021.Equity:
Wasley, A., S. Grytdal and K. Gallagher (2008). “Surveillance for acute viral hepatitis — United States, 2006...MMWR SURVEILLANCE SUMMMMWR: Surveillance Summaries.” MMWR Surveillance Summaries 57(SS-2): 1-24.
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Bridges, C. B., T. L. Watson, N. P. Nelson, M. Chavez-Torres, P. Fineis, B. Ntiri-Reid, E. Wake, J. M. Leahy, A. K. Kurian, M. A. K. Hall and E. D. Kennedy (2019). “Challenges with hepatitis B vaccination of high-risk adults – A pilot program.” Vaccine 37(35): 5111-5120.
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Miller-Handley, H., G. Paulsen, D. Hooper, D. Lazear, M. Lake and L. Danziger-Isakov (2016). “Durability of the hepatitis B seroprotection in pediatric renal transplant recipients.” Open Forum Infectious Diseases. Conference: ID Week 3(Supplement 1).
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Hechter, R. C., L. Qian, Y. Luo, D. S. Ling Grant, R. Baxter, N. P. Klein, K. Valdez Nunley, L. Aukes, C. Hogea, G. Krishnarajah, B. J. Patterson, T. M. Im and H. F. Tseng (2019). “Impact of an electronic medical record reminder on hepatitis B vaccine initiation and completion rates among insured adults with diabetes mellitus.” Vaccine 37(1): 195-201.
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Flu Vaccination Coverage, United States, 2019–20 Influenza Season: CDC. www.cdc.gov/flu/fluvaxview/coverage-1920estimates.htm
Wu, Y., J. A. Marsh, E. S. McBryde and T. L. Snelling (2018). “The influence of incomplete case ascertainment on measures of vaccine efficacy.” Vaccine 36(21): 2946-2952.
Bruxvoort, K., J. Slezak, J. W. Hsu, K. Reynolds, L. S. Sy and S. Jacobsen (2019). “Hepatitis B vaccine and risk of acute myocardial infarction among patients with diabetes.” Annals of Epidemiology 36: 71.
Rosenthal, E. M., E. W. Hall, E. S. Rosenberg, A. Harris, N. P. Nelson and S. Schillie (2020). “Assessing the cost-utility of preferentially administering Heplisav-B vaccine to certain populations.” Vaccine 38(51): 8206-8215.Top of Page
							
					
							Last Reviewed:  March 30, 2022						Source: 	National Center for Immunization and Respiratory Diseases
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