Basics
Alerts
Haemophilus influenzae
Type b (Hib) - Interim Recommendations Related To Recall - December, 2007
Merck and Co has initiated a voluntary recall in the U.S. for certain lots of two
Haemophilus influenzae type b (Hib) conjugate vaccines (PedvaxHIB® and Comvax®) as a precautionary measure because they cannot ensure sterility of the equipment used to produce the lots that have been recalled. The potency of recalled lots was not affected and no contamination of the vaccine has been detected. Children who received vaccine from recalled lots do not need revaccination or any special follow up. Providers should return unused vaccine from these recalled lots according to standard procedure. Merck does not expect normal distribution to resume until late 2008. This will likely lead to short-term shortage of Hib supply in the United States. Sanofi Pasteur currently manufactures two other Hib conjugate vaccines (ActHIB® and TriHIBit®) which are unaffected by the recall. However, it is unlikely that Sanofi Pasteur will be able to provide adequate Hib vaccine to keep up with the current CDC recommendations.
The recommended immunization schedule in the U.S. for 2007 consists of a 2-dose primary series given at 2 months and 4 months if PedvaxHIB® or COMVAX® are used, followed by a booster dose at 12-15 months. ActHIB® is recommended as a 3-dose primary series given at 2 months, 4 months, and 6 months, followed by a booster dose at 12-15 months. TriHIBit® is only recommended as a booster dose to be given at 12-15 months. Due to the projected shortage of available Hib doses, the CDC (in conjunction with ACIP, AAFP, and AAP) has recommended to temporarily defer administering the routine booster dose of Hib vaccine administered at age 12-15 months, except for children in high-risk groups. Children who are behind schedule should complete the primary series according to age-appropriate recommendations. The children who are at highest risk for Hib disease should continue to complete the entire series, including the booster dose. Children who are at highest risk include children with asplenia, sickle-cell disease, HIV infection, other immunodeficiency syndromes, malignant neoplasms, American Indian children, and Alaskan Native children. The CDC is encouraging providers who predominantly serve the American Indian/Alaskan Native populations to stock and use the PedvaxHIB® and Comvax® due to the improved response to these agents in this population. The CDC will prioritize distribution of the CDC stockpile to these areas.
For information on specific lots recalled:
CDC recommended childhood schedule:
http://www.cdc.gov/vaccines/recs/schedules/child-schedule.htm
For more information on Hib disease and vaccination:
http://www.cdc.gov/vaccines/vpd-vac/hib/default.htm
U.S. Brand Names
Medication Safety Issues
Sound-alike/look-alike issues:
International issues:
- Hiberix is also a brand name for influenza virus vaccine in multiple international markets
Generic Available
No
Pharmacologic Categories
- Vaccine, Inactivated (Bacterial)
Related Terms
- Haemophilus b Oligosaccharide Conjugate Vaccine
- Haemophilus b Polysaccharide Vaccine
- Diphtheria Toxoid Conjugate
- HbCV
- Hib Conjugate Vaccine
- Hib Polysaccharide Conjugate
- PRP-OMP
- PRP-T
Available Products
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