RotaTeq® is a three-dose, pentavalent, human-bovine reassortment vaccine, indicated for the prevention of rotavirus gastroenteritis (RVGE) in infants aged 6–32 weeks in the EU. The vaccine solution is given orally and can be administered with a number of common childhood vaccines. In the pivotal REST study, RotaTeq® showed high protective efficacy with respect to reductions in the RVGE incidence and associated hospitalizations or emergency department visits. The effectiveness and impact of the vaccine against RVGE-related healthcare use were demonstrated in several real-world studies. RotaTeq® was generally well tolerated, with no or minimal risk of intussusception.
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The manuscript was reviewed by: G. Gabutti, Department of Medical Sciences, University of Ferrara, Ferrara, Italy; A. Orrico-Sánchez, Vaccine Research, Fundación para el Fomento de la Investigación Sanitaria y, Biomédica de la Comunitat Valenciana, FISABIO-Public Health, Valencia, Spain; S. Saluja, Saran Ashram Hospital, Dayalbagh, Agra, India; T. Vesikari, Vaccine Research Centre, University of Tampere Medical School, Tampere, Finland. MSD Vaccins, the marketing-authorization holder of RotaTeq®, was also offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.
The preparation of this review was not supported by any external funding.
Conflict of interest
Y.Y. Syed and K.A. Lyseng-Williamson are employees of Adis/Springer, are responsible for the article content and declare no conflicts of interest.
Additional information about this Adis Drug Review can be found here: http://www.medengine.com/Redeem/10B99D706236BB95.
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Syed, Y.Y., Lyseng-Williamson, K.A. Pentavalent rotavirus vaccine (RotaTeq®) in the prevention of rotavirus gastroenteritis: a profile of its use in the EU. Drugs Ther Perspect 34, 143–149 (2018). https://doi.org/10.1007/s40267-018-0497-z