FDA expands indication for GSK's Hib vaccine, Hiberix

In 2009, GlaxoSmithKline ($GSK) worked with U.S. health authorities to bring its Haemophilus influenzae Type b (Hib) vaccine, Hiberix, to market. It was initially intended as a booster dose to fill a supply gap created by Merck's ($MRK) recall of two Hib conjugate vaccines. Now, the FDA has expanded the indication of GSK's Hiberix from a booster to a full-series, four-dose vaccine to immunize children aged 6 weeks to four years.

"While we were pleased that Hiberix was first approved as a booster dose to address a supply challenge in the U.S., now with the full series approved, we complete that chapter," said Patrick Desbiens, GSK senior vice president and head of U.S. Vaccines, in a statement.

The approval follows an evaluation of Hiberix's efficacy using endpoints that predict protection from invasive disease caused by Hib, GSK said in the statement.

According to the FDA, before Hib vaccines were available, Hib disease was the leading cause of bacterial meningitis among children younger than 5.

Hiberix was originally licensed outside the U.S. in 1996 and has since been approved in 78 countries. It was approved via the FDA's accelerated approval pathway in 2009, two years after Merck recalled 1.2 million doses of PedvaxHIB and Comvax and fell behind on its timeline to restore supplies of these two vaccines. Sanofi Pasteur increased production of its ActHIB, but was unable to meet demand.

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