GlaxoSmithKline Biologicals' (GSK Bio) vaccine against rotavirus infection, Rotarix, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee which evaluates the quality, safety and efficacy of medicinal products in the European Union. According to the new legislation, a European marketing authorisation from the European Commission could be expected from late February 2006 onwards which will make Rotarix the first rotavirus vaccine available to children in Europe.
GlaxoSmithKline submitted a registration file for Rotarix to the European Medicines Agency (EMEA) in December 2004. GlaxoSmithKline intends to introduce this vaccine throughout Europe immediately after the marketing authorisation has been granted, claims the company release.
The rotavirus market potential by 2010 is estimated between £1.0 - 1.3 billion. Europe accounts for 20% of the total market.
Rotarix has been developed by GSK Biologicals since 1997 when it was in-licensed from Avant Immunotherapeutics. Dr Richard Ward originally developed the vaccine at the Children's Hospital of Cincinnati.
Rotarix is the first human rotavirus vaccine available in the market. The vaccine, which is given orally, confers significant protection against rotavirus diarrhoea. Clinical trials have shown high efficacy against the most prevalent rotavirus strains. The vaccine can be co-administered with all major infant vaccines including oral polio vaccine. It is given in a two dose schedule as of six weeks of age, allowing for an early protection.
Approximately 4.5 million cases of rotavirus gastroenteritis occur yearly among children under 5 years in the EU, which makes rotavirus the most frequent vaccine preventable illness among young children in the EU.