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GSK's Rotarix protects against commonest rotaviruses

New data show that GSK's oral rotavirus candidate vaccine, Rotarix, provides protection against five rotavirus types

New data published in the 23 November edition of The Lancet show that UK-based pharmaceutical company GlaxoSmithKline's (GSK) oral rotavirus candidate vaccine, Rotarix, provides protection against five rotavirus types.

The vaccine contains a live, weakened form of natural human rotavirus derived from the most common human rotavirus strain with the goal of offering protection against the most commonly circulating and emerging rotavirus serotypes by mimicking the protective effects of natural human rotavirus infection.

The multi-centre, randomised, double-blind, placebo-controlled phase III clinical trial involved almost 4,000 European infants and the results demonstrated that two doses of Rotarix provided highly effective and sustained protection through two consecutive rotavirus seasons.

The data showed that the vaccine was highly effective against rotavirus hospitalisations (96 per cent), severe rotavirus gastroenteritis (90 per cent) and against rotavirus gastroenteritis of any severity (79 per cent). Significant protection was demonstrated against severe rotavirus gastroenteritis caused by types G1 (96 per cent), G2 (86 per cent), G3 (94 per cent), G4 (95 per cent), and G9 (85 per cent), the most commonly circulating rotavirus types around the world and in the US.

In an additional analysis, protection against severe rotavirus gastroenteritis in the period between dose one and dose two was observed to be 90 per cent.

GSK's Biologics License Application (BLA) for the candidate rotavirus vaccine is currently under review by the FDA in the US. The company has already obtained EU marketing approval.

However, Merck & Co's RotaTeq was approved in the US in February 2007, and an advisory committee of the US Centers for Disease Control and Prevention (CDC) recently voted to recommend that all infants, starting at six to 12 weeks of age, be vaccinated with RotaTeq. The product should reach the US market within the next two years, giving it an advantage over Rotarix.

Rotarix is expected to generate sales of up to GBP 500m (USD 1bn) in the EU and international markets. On top of this, a further GBP 500m in US sales is anticipated once approved.

30th September 2008

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