On Apr. 29, 2016, GlaxoSmithKline Biologicals in Research Triangle Park, North Carolina, received U.S. Food and Drug Administration (FDA) approval 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 U.S. 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 Jul. 2009.