FDA Approves Hiberix as Children’s Booster Hib Vaccine

19 August 2009 (Last Updated August 19th, 2009 18:30)

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's Hiberix as a Haemophilus influenzae type b (Hib) vaccine, used to prevent bacterial meningitis, as a booster for children. A shortage of the Hib vaccine across the US began in December 2007 and led to the deferral o

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's Hiberix as a Haemophilus influenzae type b (Hib) vaccine, used to prevent bacterial meningitis, as a booster for children.

A shortage of the Hib vaccine across the US began in December 2007 and led to the deferral of the booster dose for children who were not at high risk of infection by the US Centers for Disease Control and Prevention until June 2009.

The FDA has approved Hiberix, for children 15 months through to four years old, under the agency's accelerated approval pathway.

Until the widespread availability of Hib vaccines, the disease was the leading cause of bacterial meningitis among children under five years old in the US.