Yesterday, the U.S. Food and Drug Administration (FDA) approved GlaxoSmithKline’s (GSK) Hiberix, a Haemophilus influenzae Type b (Hib) vaccine. The vaccine has been approved as a booster dose for children in the age group of 15 months to 4 years. FDA approval was based on safety and efficacy data obtained from 7 clinical studies conducted in Europe, Latin America and Canada involving more than 1,000 children.

Hiberix was approved under the FDA’s accelerated approval pathway, mainly due to a nationwide shortage of Hib vaccines since December 2007. Merck & Co., Inc. (MRK) voluntary recalled and subsequently suspended production of 2 Hib vaccines, PedvaxHIB and COMVAX, licensed in the United States.

Following the shortage in Hib vaccines, the U.S. Centers for Disease Control and Prevention temporarily postponed the Hib vaccine booster dose for children not at a high risk for infection. This deferral was effective from Dec. 18, 2007 through Jun 25, 2009.

The launch of Hiberix should allow Glaxo to take advantage of the shortage in supply of Hib vaccines. The availability of Hiberix will ensure that children are able to complete their vaccination schedule on time. Before the introduction of Hib vaccines, Hib disease was a leading cause of bacterial meningitis in children under 5 years of age in the U.S.

Hiberix is used in nearly 100 countries and should be available in the U.S. shortly. The approval of Hiberix is a boost for Glaxo’s vaccine product portfolio. We are encouraged by the growth in the company’s vaccine business, which posted sales of £2,539 million in 2008. The vaccine portfolio consists of products like Rotarix, Synflorix, and Relenza.

The most significant product in Glaxo’s vaccine portfolio is Cervarix, a vaccine for human papillomavirus (HPV), which was approved in the E.U. in September 2007 and is currently under regulatory review in the U.S. Cervarix should contribute significantly to Glaxo’s top-line over the next several years. Once launched in the U.S., Cervarix will compete directly with Merck’s Gardasil.

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