[08 April 2013]
Products Affected - Description
Inactivated hepatitis A vaccine, 50 unit/mL, Merck (Vaqta)
Adult formulation 1 mL single-dose prefilled syringe, package of 1 (NDC 00006-4096-31) - discontinued
Adult formulation 1 mL single-dose prefilled syringe, package of 6 (NDC 00006-4096-06) - discontinued
Pediatric formulation 0.5 mL single-dose prefilled syringes, package of 6 (NDC 00006-4095-09) - discontinued
Inactivated hepatitis A vaccine, 1440 unit/mL, GlaxoSmithKline (Havrix)
Adult formulation, prefilled syringes, packages of 5 (NDC 58160-0826-48) - discontinued
Pediatric formulation 0.5 mL single-dose prefilled syringe, package of 5 (NDC 58160-0825-46) - discontinued
Reason for the Shortage
- Merck was waiting for regulatory approval of a manufacturing change.1
- Merck discontinued all adult and pediatric formulation prefilled syringe presentations.1
- GlaxoSmithKline could not provide a reason for the shortage.2
Available Products
Inactivated hepatitis A vaccine, 1440 unit/mL, GlaxoSmithKline (Havrix)2
Adult formulation 1 mL prefilled syringes, packages of 10 (NDC 58160-0826-52)
Adult formulation 1 mL single-dose vials, packages of 10 (NDC 58160-0826-11)
Pediatric formulation 0.5 mL single-dose vials, packages of 10 (NDC 58160-0825-11)
Pediatric formulation 0.5 mL prefilled syringes, packages of 10 (NDC 58160-0825-52)
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 6 (NDC 00006-4096-09)
Pediatric formulation 0.5 mL single-dose vials, packages of 10 (NDC 00006-4831-41)
Pediatric formulation 0.5 mL single-dose prefilled syringe, package of 6 (NDC 00006-4095-09)
Estimated Resupply Dates
All presentations are currently available.
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.6,7,8
- Travelers to endemic areas
- Patients with chronic liver disease
- Patients receiving clotting factor concentrates
- Persons at high risk due to their employment (eg, working with HAV-infected primates)
- Men who have sex with men
- Illicit drug abusers
- Military personnel
- Caregiver or close contact with international adoptee
Alternative Agents & Management
- 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 3,4,6,7,8
|
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%
|
|
Bivalent Inactivated Hepatitis A Virus Vaccine and Recombinant Hepatitis B Vaccine
|
|
Adults
|
Twinrix > 720 ELU/mL and 20 mcg HBsAg protein/mL
3-dose regimen: 1 mL IM at 0, 1, and 6 months
4-dose regimen: 1 mL at day 0,7, 21-30, and booster at 12 months
|
Hepatitis A
Healthy adults: 100
Adults > 40 years: 100
Hepatitis B
Healthy adults: 95-99
Adults > 40 years: 93-94
|
|
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, November 2, December 7 and 21, 2009; January 11, February 15, March 17, April 20, June 9 and 30, July 15, August 2 and 30, September 9 and 27, November 2 and 17, and December 21, 2010; and January 26, February 23, April 6, May 11, June 10, July 26, August 23, September 13, and December 12, 2011; February 8, May 4, August 22, October 4, November 14, 2012; January 23, March 4, and April 8, 2013.
- GlaxoSmithKline, (personal communications). February 25, March 11, April 6, May 4, June 9, July 28, August 26, September 28, October 19, November 4, December 7 and 21, 2009; January 13, February 19, March 17, April 21, June 9 and 30, July 15, August 3 and 30, September 9 and 27, November 2 and 19, and December 21, 2010; and January 26, February 23, April 6, May 11, June 10, July 26, August 18,September 13, December 12 and 13, 2011; August 22, October 4, November 14, 2012; January 23, March 4, and April 8, 2013.
- 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.
- Advisory Committee on Immunization Practices. Recommended Adult Immunization Schedule, 2010. Ann Internal Medicine 2010: 152(1):36-39.
Updated
Updated April 8, 2013 by Kristen Jefferies, PharmD, Drug Information Specialist. Created August 3, 2007 by Erin R. Fox, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
Disclaimer
This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.
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