[29 January 2014]
Products Affected - Description
Haemophilus b Vaccine (Tetanus toxoid conjugate) vaccine, GlaxoSmithKline
Hiberix single dose vials (NDC 58160-0806-05)
Reason for the Shortage
- Sanofi Pasteur had ActHIB in short supply due to the shortage of other combination vaccines (eg, Pentacel®).1
- GlaxoSmithKline cannot provide a reason for the shortage of Hiberix but it has not been manufactured since 2011.2
- Haemophilus b Vaccine (Tetanus toxoid conjugate) vaccine, Sanofi Pasteur1
ActHIB single dose vials (NDC 49281-0545-051)1
- Haemophilus b vaccine (Meningococcal Protein Conjugate), Merck3
Liquid PedvaxHIB, single dose vials, package of 10 (NDC 00006-4897-00)
- Haemophilus b (Meningococcal Protein Conjugate) and Recombinant Hepatitis B vaccine, Merck
Comvax single-dose vials, package of 10 (NDC 00006-4898-00)
- Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate vaccine, GlaxoSmithKline2
MenHibrix single-dose vials, package of 10 (NDC 58160-0801-11)
Estimated Resupply Dates
- GlaxoSmithKline has Hiberix single dose vials on long-term back order and the company cannot estimate a release date.2
Implications for Patient Care
- PedvaxHIB is labeled for primary and booster immunization against infection with H. influenzae type B in patients 2 to 71 months of age.4
- ActHIB is labeled for primary and booster immunization against infection with H. influenzae type B in patients 2 to 18 months of age.5
- Hiberix is labeled as a booster immunization against infection with H. influenzae type B in patients 15 to 48 months of age. Hiberix is not labeled for the primary immunization against infection with H. influenzae type B.6
- Comvax is labeled for primary and booster immunization against infection with H. influenzae type B in patients 6 weeks to 15 months of age born to mothers with a negative hepatitis B surface antigen.7
- MenHibrix is labeled for primary immunization against infection with H. influenzae type B and Neisseria meningitidis serogroups C and Y in patients 6 weeks to 18 months of age.8
- Pentacel is labeled for active immunization against tetanus, diphtheria, pertussis, poliomyelitis and invasive Haemophilus influenzae type B (DTap, IPV, HIB) as a 4-dose series in pediatric patients ages 6 weeks to 4 years old.9
Ensure patients receive the adequate number of vaccinations as outlined by the Centers for Disease Control and Prevention (CDC) Recommended Immunization Schedules.
Alternative Agents & Management
- Monovalent Haemophilus influenzae type b (Hib) containing vaccines include ActHIB, Hiberix, and PedvaxHIB. Combination vaccines containing Hib include Comvax, Pentacel, and MenHibrix. Selection of an alternative vaccine during a shortage depends on the patient’s age, comorbid conditions, and vaccination schedule.10,11,12
- The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of all infants against H. influenzae type B infection. The first dose is usually given at 2 months of age, although it may be given as early as 6 weeks of age. The dosing schedule for ActHIB is a dose at 2 months, 4 months, 6 months and a booster dose at 12 to 15 months. The dosing schedule for PedvaxHIB and Comvax is a dose at 2 months, 4 months and 12 to 15 months. The booster dose for all vaccines is given no earlier than 12 months of age and a minimum of 8 weeks after the previous dose. If the first Hib vaccine dose is given to a child ages 12 to 14 months, give a booster in 8 weeks. Give only one dose to unvaccinated children ages 15 months to 5 years. The haemophilus B vaccines are not routinely given to children > 5 years of age. The 2013 ACIP adult immunization recommendations indicate that although the Hib vaccine is not recommended for use in patients over 5 years of age, there are studies to suggest a good immunogenic response after one dose of Hib vaccine in splenectomized patients or patients with sickle cell, leukemia, HIV infection, or are otherwise immunocompromised.10,11
- Additional information from CDC regarding Hib vaccines is available.
- Sanofi Pasteur, Customer Service (personal communications and website). August 23, September 11, October 4 and 21, and December 9 and 16, 2013; and January 27, 2014.
- GlaxoSmithKline, Customer Service (personal communications and website). August 23, September 6 and 11, October 1 and 14, November 13, and December 3, 2013; and January 20, 2014.
- Merck, Customer Service (personal communications and website). September 11, October 1, and December 9 and 13, 2013; and January 27, 2014.
- Liquid PedvaxHIB. Product information. Whitehouse Station, NJ: Merck & Company; December 2010.
- ActHIB. Product Information. Swiftwater, PA: Sanofi Pasteur; 2005.
- Hiberix Product Information. Research Triangle Park, NC: GlaxoSmithKline, March 2012.
- Comvax. Product information. Whitehouse Station, NJ: Merck & Company; December 2010.
- MenHibrix Product Information. Research Triangle Park, NC: GlaxoSmithKline, March 2012.
- Pentacel Product Information. Swiftwater, PA: Sanofi Pasteur; 2011.
- Centers for Disease Control and Prevention (CDC). Recommended Immunization Schedules for Persons Aged 0–18 Years – United States, 2008. MMWR Morb Mortal Wkly Rep. 2013; 62:early release. Available online. Accessed August 23, 2013.
- Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices (ACIP) recommended immunization schedules for persons aged 0 through 18 years and adults aged 19 years and older--United States, 2013. MMWR Surveill Summ. 2013 Feb 1;62 Suppl 1:1. Erratum in: MMWR Surveill Summ. 2013 Apr 5;62(13):256. PubMed PMID: 23364301.
- Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices, Vaccines for Children Program, Vaccines to Prevent Haemophilus influenza type b. Resolution No. 2/13-2. Available online. Accessed September 11, 2013.
Updated January 29, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist, Drug Information Service. Created November 9, 2007 by Jane Chandramouli, PharmD, Drug Information Specialist and Erin R. Fox, PharmD, Drug Information Specialist. Copyright 2014, 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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