Bulletin
Hepatitis A Virus Vaccine Inactivated
06 November 2009
Products Affected - Description
Inactivated hepatitis A vaccine, 50 unit/mL, Merck (Vaqta)
Adult formulation 1 mL single-dose vials, packages of 10 (NDC 00006-4841-41)
Adult formulation 1 mL single-dose vial, package of 1 (NDC 00006-4841-00)
Adult formulation 1 mL single-dose prefilled syringe, package of 1 (NDC 00006-4096-31)
Adult formulation 1 mL single-dose prefilled syringe, package of 6 (NDC 00006-4096-06)
Adult formulation 1 mL single-dose prefilled syringe, package of 6 (NDC 00006-4096-09)
Inactivated hepatitis A vaccine, 1440 unit/mL, GlaxoSmithKline (Havrix)
Pediatric formulation, 0.5 mL, single-dose prefilled syringe, package of 5 (NDC 58160-0825-46)
Reason for the Shortage
Merck is waiting for regulatory approval of a manufacturing change.1 Merck halted manufacturing of all Vaqta presentations in October, 2007.1
Estimated Resupply Dates
- Merck has available Vaqta pediatric vaccine in 0.5 mL single-dose vials, packages of 10 (NDC 00006-4831-41). The adult formulations of Vaqta are not expected to be available in 2009. Availability information for 2010 will be updated as it comes available.1
- GlaxoSmithKline has available Havrix adult vaccine in vials (NDC 58160-0826-11) and syringes (NDC 58160-0826-46). Havrix pediatric vaccine in single-dose vials, packages of 10 is also available (NDC 58160-0825-11). The Havrix pediatric vaccine in syringes is on back order and the company is unable to estimate a release date.2
Implications for Patient Care
- Inactivated hepatitis A virus vaccine is labeled for immunization against hepatitis A virus infection in patients = 12 months old.3,4 Vaccination is recommended for patients at increased risk for exposure to the hepatitis A virus.3-5 It is unknown whether booster doses are necessary. However, antibodies to the virus are detectable in children for = 5 years and in adults for = 10 years after primary immunization, and the vaccine may offer protection for at least 20 years.6,7
- The following groups of patients are at increased risk of exposure to the hepatitis A virus.6,7
- Travelers to endemic areas
- Patients with chronic liver disease
- Patients at high risk due to their employment
- Men who have sex with men
- Illicit drug abusers
- Military personnel
Alternative Agents & Management
- GlaxoSmithKline has good supplies of Havrix.2
- The Table below outlines specific dosage regimens for the various hepatitis virus vaccines.
- Inactivated hepatitis A virus vaccine products are interchangeable for completion of a basic immunization series.6,7 The vaccines are considered equivalent for the prophylaxis of infection, although their potencies are measured differently.6,7 Antigenic activity is measured in enzyme linked immunoassay units (ELU) for Havrix and in units of hepatitis A viral antigen for Vaqta.3,4
Table. Recommended Dosage Regimens of Hepatitis A Virus Vaccine 3,4,6,7
|
Patient-Risk Group
|
Recommended Dosage Regimen
|
% Patients with Protective Antibodies after Primary Series
|
|
Inactivated Hepatitis A Virus Vaccine
|
|
Children
12 months through 18 years
|
Havrix 720 ELU/0.5 mL pediatric formulation
2-dose regimen: 0.5 mL IM at 0 and 6-12 months
Vaqta 25 U/0.5 mL pediatric/adolescent formulation
2-dose regimen: 0.5 mL IM at 0 and 6-18 months
|
Havrix: 100%
Vaqta: 100%
|
|
Adolescents
(through 18 years)
|
Havrix 720 ELU/0.5 mL pediatric formulation
2-dose regimen: 0.5 mL IM at 0 and 6-12 months
Vaqta 25 U/0.5 mL pediatric/adolescent formulation
2-dose regimen: 0.5 mL IM at 0 and 6-18 months
|
Havrix: 100%
Vaqta: 100%
|
|
Adults
19 years and older
|
Havrix 1440 ELU/mL adult formulation
2-dose regimen: 1 mL IM at 0 and 6-12 months
Vaqta 50 U/mL adult formulation
2-dose regimen: 1 mL IM at 0 and 6 months
|
Havrix
Healthy adults: 100%
Chronic liver disease: 95-98%
Vaqta: 100%
|
|
Abbreviations: ELU = enzyme-linked immunoassay units, U = units
|
Related Shortages
References
- Merck, (personal communications). August 2, 3, and 21, September 6, and November 28, 2007, May 16, August 18, October 24, and December 1, 2008; and February 25, March 10, April 6, May 4, June 9, July 28, August 26, September 28, October 19, and November 2, 2009.
- GlaxoSmithKline, (personal communications). February 25, March 11, April 6, May 4, June 9, July 28, August 26, September 28, October 19, and November 4, 2009.
- Havrix. Product information. Research Triangle Park, NC: GlaxoSmithKline; 2006 December.
- Vaqta. Product information. Whitehouse Station, NJ: Merck & Company; 2006 October.
- Fiore AE, Wasley Annemarie, Bell BP. Prevention of Hepatitis A Through Active or Passive Immunization, Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2006;55(RR-7):1-23.
- Hepatitis A. In: Pickering LK, ed. 2006 Red Book: Report of the Committee on Infectious Diseases. 26th ed. Elk Grove Village, IL: American Academy of Pediatrics;2006:326-335.
- Hepatitis A vaccine (HAV). In: Grabenstein JD, ed. ImmunoFacts. St. Louis, MO: Facts and Comparisons; 2006:175-185.
Updated
Updated November 6, 2009 by Dave Peterson, Pharm.D., Drug Information Specialist. Created August 3, 2007 by Erin R. Fox, Pharm.D., Drug Information Specialist. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
Back to Drug Shortage Product Bulletins