Hepatitis B Vaccine Recombinant

18 November 2009

Products Affected - Description

Reason for the Shortage

• Merck is experiencing manufacturing issues with many of their vaccine products.¹ A supply interruption of Recombivax HB is expected for 2009. Once supplies of the adult and dialysis formulations of Recombivax HB are depleted, they will not be available again until 2010. The pediatric formulation will not be affected.²
• GlaxoSmithKline’s product has been unavailable due to supply and demand, and product packaging changes.³
• GlaxoSmithKline is working with the CDC to determine vaccine supply needs for the second half of 2009.^2,3 The CDC has released some pediatric hepatitis B Vaccine from its stockpile to allow for vaccine availability during this shortage.²
• The CDC currently recommends no change in routine hepatitis B vaccination schedules for adults or children.²

Estimated Resupply Dates

• Merck has available pediatric Recombivax HB single-dose vials (NDC 0006-4981-00). All presentations of adult formulation Recombivax HB are unavailable until 2010.¹
• GlaxoSmithKline has available pediatric Engerix B in prefilled syringes (NDC 58160-0820-46) and single dose vials (NDC 58160-0820-11). Engerix B adult single dose vials and prefilled syringes are on back order and the company estimates a release date in mid-December, 2009.³

Implications for Patient Care

• Recombinant hepatitis B vaccine is labeled for immunization against hepatitis B virus infection.^4,5 Vaccination is recommended for all patients, especially those at increased risk for exposure to the hepatitis B virus. The two hepatitis B vaccine products are equally effective.^6,7 Because hepatitis D virus infection occurs only in patients already infected with the hepatitis B virus, immunization with recombinant hepatitis B vaccine also confers immunity against the hepatitis D virus.⁸
• The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of all infants against hepatitis B virus infection, regardless of maternal hepatitis B surface antigen (HBsAg) status.⁹ The first dose should be given within 12 hours of birth in infants with an HBsAg-seropositive mother and to infants whose mothers’ HBsAg status is unknown. In infants with an HBsAg-seronegative mother, the first dose may be given prior to hospital discharge. The monovalent hepatitis B virus vaccine should be given for the first dose of the series. The remainder of the series may be completed using monovalent hepatitis B virus vaccine or a combination vaccine.^9,10
• In June, 2009 the CDC published guidance on the importance of using the monovalent hepatitis B virus vaccine to complete the second and third dose of the hepatitis B vaccination series for infants receiving Pentacel vaccine (DTaP-IPV/Hib).¹¹ Pentacel is one of two agents currently available to immunize against H. influenza type B. Use of a combination hepatitis B vaccine product like Pediarix® in combination with Pentacel® could result in excess doses of DTaP or IPV.  
  • If providers have the monovalent vaccine available, they should follow the recommended ACIP vaccine schedule.^9-11
  • If the infant’s mother is HBsAg positive or the HBsAg status is unknown and the provider does not have the monovalent vaccine available for the 2nd or 3rd dose, contact the state or local health department to obtain the monovalent vaccine and give vaccine as recommended in ACIP vaccine schedule.  The vaccine series for infants whose mother’s are HBsAg positive or the status is unknown, must complete the full hepatitis B series by 6 to 8 months of age.¹¹
  • If the infant’s mother in confirmed HBsAg negative and providers do not have the monovalent hepatitis B vaccine available for the 2nd dose, obtain the monovalent vaccine and administer as soon as possible according to the recommended ACIP vaccine schedule. Give the 3rd dose between 6 to 18 months of age.¹¹
• Table 1 lists the groups of patients who are at increased risk of exposure to the hepatitis B and A viruses.

Safety

Ensure patients receive the adequate number of vaccinations as outlined by the Centers for Disease Control and Prevention (CDC) Recommended Immunization Schedules.^9,10

Alternative Agents & Management

Hepatitis B virus vaccines

• Table 2 outlines specific dosage regimens for the various hepatitis virus vaccines.
• Recombinant hepatitis B vaccine products are interchangeable for the completion of a basic immunization series or for booster doses, although the quantity of viral antigen and dosage volume vary between preparations.^4,5,12

Related Shortages

• Hepatitis A Virus Vaccine Inactivated
• Hepatitis B Vaccine Recombinant and Bivalent Haemophilus influenzae type B conjugate
• Influenza Virus Vaccine
• Measles Virus Vaccine Live— No Longer Available
• Measles, Mumps, Rubella and Varicella Virus Vaccine Live Injection
• Meningococcal Polysaccharide Vaccine— Resolved
• Mumps Virus Vaccine Live— No Longer Available
• Rabies Vaccine— Resolved
• Rubella Virus Vaccine Live Injection— No Longer Available
• Varicella Virus Vaccine Live— Resolved
• Yellow Fever Vaccine Injection
• Zoster Vaccine Live— Resolved

1. Merck, Customer Service (personal communications). November 21 and 27, December 3 and 11, 2001; January 28, February 27, April 19, May 22, August 5 and September 10, 2002; August 13, October 28, and November 4, 2003; October 31, 2005; January 20, March 27, May 2, September 9, 10, and 11, October 2, and December 5, 2006; February 20, and December 13, 2007; August 18, and December 1, 2008; February 24, March 10 and 25, April 6, May 4, 11, and 18, June 12, August 17, October 19, and November 2 and 16, 2009.
2. Centers for Disease Control and Prevention. Current Vaccine Shortages & Delays.  Accessed June 15, 2009.
3. GlaxoSmithKline, Customer Service (personal communications). February 24, March 11 and 25, April 6 and 22, May 4, and May 11, June 17, August 17, September 15, October 6 and 26, and November 6 and 18, 2009.
4. Engerix-B. Product information. Research Triangle Park, NC: GlaxoSmithKline; 2006 December.
5. Recombivax HB. Product information. Whitehouse Station, NJ: Merck & Company; 2006 October.
6. Coates T, Wilson R, Patrick G, Andre F, Watson V. Hepatitis B vaccines: Assessment of the seroprotective efficacy of two recombinant DNA vaccines. Clin Ther. 2001;23:392-403.
7. Hepatitis B. In: Pickering LK, ed. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics;2006:335-355.
8. Hepatitis D. In: Pickering LK, ed. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics;2006:359-360.
9. Centers for Disease Control and Prevention (CDC). Recommended Immunization Schedules for Persons Aged 0–18 Years – United States, 2008. MMWR Morb Mortal Wkly Rep. 2008 Jan 11;57(1):Q1-Q4. Accessed January 14, 2008.
10. Immunization Action Coalition. Summary of Rules for Childhood and Adolescent Immunization, October 2007. St., Paul, MN: Merck. Accessed November 9, 2007.
11. Centers for Disease Control and Prevention (CDC). Protecting infants against Hepatitis B virus infection when using Pentacel® vaccine during the Hib vaccine shortage. Accessed June 15, 2009.
12. Hepatitis B vaccines (HBV). In: Grabenstein JD, ed. ImmunoFacts. St. Louis, MO: Facts and Comparisons; 2007:193-204.
13. Twinrix. Product information. Research Triangle Park, NC: GlaxoSmithKline; 2007 April.

Updated

Updated November 18, 2009 by Michelle Wheeler, Pharm.D., Drug Information Specialist. Created December 11, 2001 by M. Christina Beckwith, Pharm.D., Drug Information Specialist and Erin R. Fox, Pharm.D., Drug Information Specialist. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.

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