2022 CDC Hepatitis B Vaccination Recommendations for the Community Pharmacist

This article was sponsored by Dynavax.

Community pharmacists and pharmacy technicians are uniquely positioned on the front lines of patient care to substantially improve vaccination awareness and accessibility, ultimately supporting better patient and population health. Through a pharmacist’s access to important patient information and direct conversations with patients, they can identify eligible individuals for vaccine-preventable diseases, like hepatitis B, which can have serious acute and chronic health consequences.1 Chronic hepatitis B can lead to cirrhosis, liver cancer, and death1; 15% of cirrhoses are caused by hepatitis B virus (HBV).2

Beginning in 1991, infants began getting vaccinated against HBV at birth.3 While this led to a dramatic reduction of hepatitis B infection rates among children, many adults born before the 1991 hepatitis B universal vaccination of infants recommendation remain unprotected and at risk for infection.

NEW AND UPDATED 2022 CDC RECOMMENDATIONS

In February 2022, the Centers for Disease Control & Prevention (CDC) recommended universal hepatitis B vaccination for all adults aged 19 to 59. Additionally, adults 60 years and older who do not have additional risk factors for HBV infection are recommended for vaccination. This announcement comes as hepatitis B rates among adults are on the rise.4

Although effective hepatitis B vaccines have been available in the United States for decades, the prevalence of cases of acute HBV has increased by 14% from 2014 to 2019.1 In 2019, more than 95% of acute HBV infections occurred in adults aged 20 years and older.1

IMPORTANCE OF VACCINE SERIES COMPLETION

Effective vaccination and completion of the hepatitis B vaccine series is essential to achieving protective immunity.5,6

Hepatitis B vaccination completion rates are suboptimal. Three-dose hepatitis B vaccines (eg, Engerix-B [GlaxoSmithKline] and Recombivax HB [Merck]) have potential challenges with series completion.7,8 Just 24.8% of adults (aged ≥ 19 years) completed 3 or more doses of a hepatitis B vaccine series in 2018.9 Data collected from a CDC-led hepatitis B vaccination program for high-risk adults showed that just 22.3% of high-risk adults completed a 3-dose hepatitis B vaccine series.10

Pharmacists can emphasize the importance of hepatitis B vaccine dose-series completion and can offer HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is the first and only 2-dose hepatitis B vaccine for adults that is completed in 1 month to protect adults 18 years of age and older from hepatitis B infection.11

The 2022 CDC recommendation, coupled with the availability of a two-dose vaccine as an alternative to a three-dose vaccine, are important events in the country’s strategic plan to eliminate hepatitis B by 2030 and help protect thousands of individuals from serious illness or death.12

HEPLISAV-B [HEPATITIS B VACCINE (RECOMBINANT), ADJUVANTED]

HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of HBV in adults aged 18 years and older.11 Refer to Figure 1 for information regarding dosing and administration for HEPLISAV-B.11


Clinical Efficacy

Across 5 clinical trials, a total of 9597 adults aged 18 to 70 years received at least 1 dose of HEPLISAV-B.11 Three of these trials were randomized, active controlled, observer-blinded, multicenter phase 3 clinical trials that evaluated the immunogenicity of HEPLISAV-B compared with Engerix-B. Adults were randomized to receive either 2-dose vaccination with HEPLISAV-B at 0 and 1 months followed by saline placebo at 6 months or 3-dose vaccination with Engerix-B at 0, 1, and 6 months.11

The results of these 3 clinical trials demonstrated that HEPLISAV-B provided faster and higher rates of seroprotection (defined as the percentage of adults with hepatitis B surface antibody concentration of at least 10 mIU/mL against hepatitis B surface antigen) compared with Engerix-B, including in subpopulations with type 2 diabetes and other known hyporesponsive populations. In a trial of adults aged 40 to 70, there was a 19.6% (95% CI, 14.7-24.8) difference between groups in the rate of protective immunity at week 12 for HEPLISAV-B vs at week 32 for Engerix-B population aged 40 to 70 (Figure 2).6,11,13

Safety

The safety profile of HEPLISAV-B was demonstrated using data derived from the largest clinical trial safety database for a hepatitis B vaccine (N = 14,238).14 The most commonly reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).11

Please see Important Safety Information within this article.


Vaccine Series Completion Rate With HEPLISAV-B

A nested cohort study of 10,888 adults evaluated hepatitis B vaccine series completion rates in those who initiated a 2-dose vaccine series with HEPLISAV-B (n = 4727) and a 3-dose vaccine series with Engerix-B (n = 6161) at Kaiser Permanente Southern California. Results demonstrated that significantly fewer adults completed the Engerix-B versus HEPLISAV-B vaccine series (26% vs 45%, respectively; P < .001). In this study, HEPLISAV-B was associated with a 77% greater chance of completion compared with Engerix-B.15

ROLE OF THE PHARMACIST

As community pharmacies are easily accessible and convenient immunization destinations, pharmacists have an important role to help build trust in vaccines, provide information on vaccines available, and provide a strong recommendation in support of vaccines to reduce vaccine-preventable illnesses. Pharmacy technicians can also be empowered to provide support by initiating conversations regarding vaccine options for hepatitis B.

With immunization records often readily available in the pharmacy, pharmacists and pharmacy technicians have an opportunity to identify adults for hepatitis B vaccination in alignment with the 2022 CDC recommendations based on their age and by checking their hepatitis B vaccination completion status.4,5,16 For adults who come to the pharmacy for other vaccines (eg, influenza or shingles), advise that the hepatitis B vaccine can be added and administered during the same visit.

Inform individuals that 3-dose hepatitis B vaccination requires 6 months before completion. HEPLISAV-B is the only 2-dose hepatitis B vaccine for adults aged 18 years and older that is completed with 2 injections over a month period.11

INDICATION

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

IMPORTANT SAFETY INFORMATION

Do not administerHEPLISAV-B®️ to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component ofHEPLISAV-B®️, including yeast.

Appropriate 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®️.

Hepatitis 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 seven days of vaccination were injection site pain (23%–39%), fatigue (11%–17%), and headache (8%–17%).

For full Prescribing Information for HEPLISAV-B®️click here.

REFERENCES

  1. Centers for Disease Control and Prevention. Viral Hepatitis Surveillance Report, United States, 2019. May 2021. Accessed March 29, 2022. Atlanta: U.S. Department of Health and Human Services; 2021. https://www.cdc.gov/hepatitis/statistics/2019surveillance/pdfs/
    2019HepSurveillanceRpt.pdf
  2. Starr SP, Raines D. Cirrhosis: diagnosis, management, and prevention. Am Fam Physician. 2011;84(12):1353-1359.
  3. Centers for Disease Control and Prevention. Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR. 1991;40(No. RR-13):1-19.
  4. Murthy N, Wodi AP, Bernstein H, McNally V, Cineas S, Ault K. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(7):229-233. doi:10.15585/mmwr.mm7107a1
  5. 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.
  6. 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.
  7. Engerix-B [Hepatitis B Vaccine (Recombinant)] injectable suspension, for extramuscular use. Prescribing information. GlaxoSmithKline Biologicals; 2021. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Engerix-B/pdf/ENGERIX-B.PDF
  8. Recombivax HB Hepatitis B Vaccine (Recombinant). Prescribing information. Merck Sharp & Dohme Corp; 1986-2020. https://www.merck.com/product/usa/pi_circulars/r/recombivax_hb/recombivax_pi.pdf
  9. Lu PJ, Hung MC, Srivastav A, et al. Surveillance of Vaccination Coverage Among Adult Populations -United States, 2018. MMWR Surveill Summ. 2021;70(3):1-26. doi:10.15585/mmwr.ss7003a1
  10. Bridges CB, Watson TL, Nelson NP, et al. Challenges with hepatitis B vaccination of high risk adults – A pilot program. Vaccine. 2019;37(35):5111-5120. doi:10.1016/j.vaccine.2019.05.089
  11. HEPLISAV-B [Hepatitis B Vaccine [Recombinant], Adjuvanted] Solution for Intramuscular Injection. Prescribing information. Dynavax Technologies Corporation; 2020. Accessed March 14, 2022. https://www.heplisavb.com/assets/pdfs/HEPLISAV-B-Prescribing-Information.pdf
  12. U.S. Department of Health and Human Services. Viral hepatitis national strategic plan for the United States: a roadmap to elimination (2021–2025). 2020. Washington, DC. https://www.hhs.gov/sites/default/files/Viral-Hepatitis-National-Strategic-Plan-2021-2025.pdf
  13. 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. doi:10.1016/j.vaccine.2017.12.038
  14. Dynavax Technologies Corporation. FDA Advisory Committee Briefing Document. HEPLISAV-B™ [Hepatitis B Vaccine (Recombinant), Adjuvanted] vaccines and related biological products. July 28, 2017. Accessed March 31, 2022. https://www.fda.gov/media/106639/download
  15. Bruxvoort K, Slezak J, Huang R, et al. Association of number of doses with hepatitis b vaccine series completion in US adults. JAMA Netw Open. 2020;3(11):e2027577. doi:10.1001/jamanetworkopen.2020.27577
  16. Shen AK, Peterson A. The pharmacist and pharmacy have evolved to become more than the corner drugstore: a win for vaccinations and public health. Hum Vaccin Immunother. 2020;16(5):1178-1180. doi:10.1080/21645515.2019.1660119

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May 2022 US-22-00-00192