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Abstract
Rotarix® was first licensed in 2004 and rapidly introduced into private and public markets worldwide. In a previous 2009 article, we reviewed the impact of rotavirus-associated disease, the rationale for different vaccines, prelicensure efficacy studies and cost–effectiveness studies for Rotarix. As of September 2011, Rotarix had been licensed in 123 countries in the Americas, Europe, Australia, Africa and Asia, of which 27 have incorporated the vaccine into national or regional immunization programs. The current review intends to provide the reader with further insight into this vaccine, focusing mainly on the new information obtained after a 6-year postlicensure period. This review will provide only a brief summary of prelicensure studies extensively discussed in the previous publication and refer, in more depth, to the worldwide experience with the vaccine, vaccine impact, and safety observed in effectiveness and observational studies, including a particular analysis on protection against rotavirus G2P[4].
Financial & competing interests disclosure
M O’Ryan was the principal investigator for the Multicenter Human Rotavirus Vaccine Trial sponsored by GlaxoSmithKline Biologicals, and was chairman of the TAG group supervising a second vaccine effectiveness study of RotaTeq™ in Nicaragua. M O’Ryan has received consulting and lecture fees from GlaxoSmithKline Biologicals. A Linhares was the principal investigator of studies with the Human Rotavirus Vaccine in Belém, Brazil, and has received research funding from GlaxoSmithKline Biologicals. The authors have accepted suggestion from GlaxoSmithKline Biologicals on product-specific content in order to provide a higher level of medical accuracy. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.