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Two rotavirus vaccines, Rotarix™ and RotaTeq™, are currently licensed in Europe, in the US and in other countries. Both vaccines are considered equally safe and efficacious, but they differ in their antigen composition and immunisation schedule.
Rotarix™ is a monovalent live vaccine containing an attenuated G1P1A[8] human rotavirus. RotaTeq™ is a pentavalent vaccine that contains five live reassortant rotaviruses derived from human and bovine strains. Both vaccines are administered orally; Rotarix™ in a two-dose schedule to infants of approximately 2 and 4 months of age, whilst for RotaTeq™, the recommended schedule is three doses at 2, 4 and 6 months.
Our team is responsible for the testing of rotavirus vaccines before they are released onto the European market. We also test these vaccines for other countries as part of our collaboration with the World Health Organisation.
Rotarix™ is tested by in vitro methods in CCID50 assays, whereas RotaTeq™ is tested in molecular biological assays using quantitative RT-PCR.
We work closely together with our colleagues at the European Directorate for the Quality of Medicines and Healthcare (EDQM) and in the Official Medicines Control Laboratories (OMCL) network. Our group contributes to the development and the revision of international policies and guidelines that control the quality, safety and efficacy of rotavirus and other vaccines (European Pharmacopoeia, OCABR batch release guidelines).