Food and Drug Administration Approval for Use of Hiberix as a 3-Dose Primary Haemophilus Influenzae Type b (Hib) Vaccination Series

Elizabeth C. Briere, MD


Morbidity and Mortality Weekly Report. 2016;65(16):418-419. 

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On January 14, 2016, GlaxoSmithKline Biologicals (Research Triangle Park, North Carolina) received approval from the Food and Drug Administration (FDA) to expand use of Hiberix (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]) for a 3-dose infant primary vaccination series at ages 2, 4, and 6 months. Hiberix was first licensed in the United States in August 2009 for use as a booster dose in children aged 15 months through 4 years under the Accelerated Approval Regulations, in response to a Haemophilus influenzae type b (Hib) vaccine shortage that lasted from December 2007 to July 2009.[1] Expanding the age indication to include infants provides another vaccine option in addition to other currently licensed monovalent or combination Hib vaccines recommended for the primary vaccination series.* Hiberix contains 10 μg purified capsular polyribosyl ribitolphosphate (PRP) conjugated to 25 μg tetanus toxoid (PRP-T) and is supplied as a single-dose vial of lyophilized vaccine to be reconstituted with saline diluent. For the 3-dose primary series, a single (0.5 mL) dose should be given by intramuscular injection at ages 2, 4, and 6 months; the first dose may be given as early as age 6 weeks. The recommended catch-up schedule for PRP-T vaccines ( should be followed. As previously recommended, a single booster dose should be administered to children aged 15 months through 18 months; to facilitate timely booster vaccination, Hiberix can be administered as early as age 12 months, in accordance with Hib vaccination schedules for routine and catch-up immunization.[1–3]

*PedvaxHib (Haemophilus b Conjugate Vaccine [Meningococcal Protein Conjugate] manufactured by Merck & Co., Kenilworth, NJ) (; ActHIB (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate], manufactured by Sanofi Pasteur, Swiftwater, PA) (; Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate [Tetanus Toxoid Conjugate] Vaccine, manufactured by Sanofi Pasteur) (; and MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine, manufactured by GlaxoSmithKline Biologicals, Research Triangle Park, NC) (