Products Affected - Description
ActHIB intramuscular powder for solution, Sanofi Pasteur
10 mcg, single dose vial, 5 count (NDC 49281-0545-05)
Hiberix intramuscular powder for solution, GlaxoSmithKline
10 mcg, single dose vial, 10 count (NDC 58160-0806-05)
Reason for the Shortage
- GlaxoSmithKline cannot provide a reason for the shortage of Hiberix.1
- Sanofi Pasteur has ActHIB in short supply due to the shortage of other combination vaccines (eg, Pentacel).2,3
- Merck has PedvaxHIB (Haemophilus b meningococcal protein conjugate vaccine) available.4
PedvaxHIB intramuscular solution for injection, Merck
7.5 mcg, 0.5 mL single dose vial, 10 count (NDC 00006-4897-00)
Estimated Resupply Dates
- GlaxoSmithKline has Hiberix single dose vials on back order and the company estimates a release date in Summer 2016.1
- Sanofi Pasteur has ActHib vaccine on allocation.2
Implications for Patient Care
- ActHIB is labeled for primary and booster immunization against infection with H. influenzae type B as a 4-dose series in pediatric patients ages 2 months to 5 years.5
- Hiberix is labeled for primary and booster immunization against infection with H. influenzae type B in patients ages 6 weeks to 4 years of age.6
- PedvaxHIB is labeled for primary and booster immunization against infection with H. influenzae type B in patients 2 to 71 months of age.7
Ensure patients receive the adequate number of vaccinations as outlined by the Centers for Disease Control and Prevention (CDC) Recommended Immunization Schedules.8,9
Alternative Agents & Management
The CDC has a guidance document available for clinicians during this shortage.10
- GlaxoSmithKline (personal communications). January 14 and February 3, 2016.
- Sanofi Pasteur (personal communications). January 14 and February 3, 2016.
- Sanofi Pasteur. Dear Health Care Provider Letter (December 2015). Accessed January 14, 2016.
- Merck (personal communications and website). January 25, 2016.
- Sanofi Pasteur. ActHIB Haemophilus b Conjugate Vaccine (Tetanus toxoid conjugate) Solution for Intramuscular Injection [product labeling]. Swiftwater, PA: Sanofi Pasteur; 2015.
- GlaxoSmithKline. Hiberix Haemophilus b Conjugate Vaccine (Tetanus toxoid conjugate) Solution for Intramuscular Injection [product labeling]. Research Triangle Park, NC: GlaxoSmithKline, January 2016.
- Merck & Company. Liquid PedvaxHIB Haemophilus b Conjugate Vaccine (Meningococcal protein conjugate) Injection [product labeling]. Whitehouse Station, NJ: Merck & Company; December 2010.
- Centers for Disease Control and Prevention (CDC). General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practice. MMWR Morb Mortal Wkly Rep. 2011 Jan 28;60(RR02):1-60. Accessed January 14, 2016.
- Department of Health and Human Services, Centers for Disease Control and Prevention. Recommended Immunization Schedule for Persons Ages 0 to 18 Years, United States 2015. Accessed January 14, 2016.
- Department of Health and Human Services, Centers for Disease Control and Prevention. Guidance for vaccinating children during the 2015-16 Pentacel manufacturing delay. Accessed January 14, 2016.
Updated February 3, 2016 by Jane Chandramouli, PharmD, Drug Information Specialist. Created January 14, 2016 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.
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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