Safety of Rotarix and Rotateq rotavirus vaccines
At its meetings in December 2004 and December 2005, the Global Advisory Committee on Vaccine Safety reviewed efficacy and safety data for Rotarix™ (GSK Biologicals) and Rotateq™ (Merck Research Laboratories) rotavirus vaccines. These data were provided to the Committee in confidence by the two companies. The results from these trials have now been published and confirm the high efficacy of both vaccines against severe rotavirus diarrhoea and the absence of evidence of an increased risk of intussusception associated with either vaccine.
Based on those data, the Committee concluded that the pre-licensing safety profiles of the current vaccines were reassuring. The Committee also considered that the possibility remained of a risk of intussusception or of other adverse effects during routine use of the vaccines and that post-marketing surveillance will be key to addressing safety issues at a population level.
At its meeting in June 2006, the Committee noted that WHO is developing a generic protocol for post-marketing surveillance of rotavirus vaccine safety that can be adapted at country level for implementation. The Committee strongly recommended that introduction of rotavirus vaccines should be associated with careful consideration of post-marketing surveillance at country level and securing its funding as an essential part of immunization programmes.
References
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Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006; 354:23-33. -
Full text article
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Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006; 354:11-22.
Last updated: 25 July 2006