Haemophilus influenzae type B (HiB) VACCINE

Hiberix, a new vaccine against Haemophilus influenzae type b (Hib), has been approved by the US FDA as a booster dose. The vaccine was approved through an accelerated process to ease the shortage of Hib vaccine in the US. Link to FDA News Release (Aug 19 09)
Continued Shortage of Haemophilus influenzae Type b (Hib) Conjugate Vaccines and Potential Implications for Hib Surveillance --- United States, 2008. MMWR Nov 21 2008:57(46);1252-5. [Dec 08]
- no increase in disease due to shortage
IVS has learned that no samples of the recalled lots were found to be contaminated. [Dec 08]
Pentacel, a vaccine for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b for infants and children 6 weeks through 4 years of age (prior to fifth birthday), was approved by the US FDA in June 2008.
Ten lots of PedvaxHIB and two lots of COMVAX are being voluntarily recalled by Merck and Co due to concerns about product sterility. The recall involves approximately 1 million doses of vaccine. The risk of vaccine contamination is reportedly theoretical; no vaccines have been found to be contaminated and there have been no reports of illness or injury. (Dec 07)
- The FDA has listed the specific lots that are being recalled at: www.fda.gov/cber/recalls/merckhib121107.htm
- CDC Q&A regarding the recall: http://www.cdc.gov/vaccines/recs/recalls/hib-recall-faqs-12-12-07.htm
- Merck's National Service Center that can answer questions about medical and other issues related to this recall: 1-800-672-6372
- Letter from Merck with more information: http://www.cdc.gov/vaccines/vac-gen/shortages/downloads/hib-recall-12-12-07.doc

This page was last updated on February 05, 2010