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Tolerance of rotavirus vaccine Volume 15, issue 4, Octobre-Novembre-Décembre 2012

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Authors
CHU Dupuytren, laboratoire de bactériologie-virologie-hygiène, UMR Inserm 1092, 2, avenue Martin-Luther-King, 87042 Limoges cedex, France

Two new rotavirus vaccines, Rotarix ® (GSK) and RotaTeq ® (Sanofi-Pasteur MSD), have been found to be safe and effective in large clinical trials. Because a previously licensed rotavirus vaccine (Rotashield ®) was associated with an increased risk of intussusception in the period immediately after vaccination, this adverse event has been carefully monitored for the current vaccines. Post-marketing surveillance of both rotavirus vaccines has detected a small increased risk of intussusception (in about 1-2/100,000 vaccinated infants) in some settings shortly after the first dose. To limit this risk, it is imperative that the first dose of either vaccine is administered between 6 and 12 weeks of age. The relationship between rotavirus vaccines and Kawasaki's disease, diabetes or autoimmune diseases has not been established. The detection of porcine circovirus (PCV-1 and/or PCV-2) sequences in rotavirus vaccines is not associated with any known risk, but future rotavirus vaccines should be free of PCV. The risk-benefit ratio is favourable for these vaccines, however, regulatory agencies and immunisation committees continue to recommend the use of rotavirus vaccine with strict post-marketing surveillance for rotavirus vaccine safety.