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Rotavirus Vaccination in Europe: The Time Has Finally Arrived

In 1998, the first rotavirus vaccine (RotaShield, Wyeth-Lederle Vaccines, New York, NY) was licensed in the United States and was recommended for routine immunization of all US infants (1). A pivotal efficacy trial of RotaShield had been conducted in Finland (2), and in anticipation of the availability of RotaShield, authorities in many European countries were reviewing the health and economic burden of rotavirus disease to guide decisions on vaccine use. However, <1 year after its introduction, RotaShield was abruptly withdrawn from the US market after postlicensure surveillance identified that it was associated with intussusception (3). Shortly thereafter, the manufacturer stopped production of RotaShield and discussions about its use in Europe were halted. The European community now has a second chance to realize the potential health benefits of rotavirus vaccines. In early 2006, promising results were reported for large clinical trials of 2 new rotavirus vaccines (RotaTeq, Sanofi Pasteur MSD, Lyon, France; and Rotarix, GlaxoSmithKline Biologicals, Rixensart, Belgium) (4,5). Later in the year, both of these vaccines were licensed by the European Medicines Agency. RotaTeq, now licensed in more than 61 countries, was recommended for routine immunization of US infants in February 2006 and, up until June 2007, more than 6 million doses were distributed in the United States (6,7). Rotarix is not yet