May 14, 2010
FDA recommends resumption of rotavirus vaccine useThe FDA has revised its recommendations on the suspension of rotavirus vaccine use and has determined that it is appropriate for healthcare providers to resume the use of Rotarix (live, attenuated human G1P rotavirus vaccine, from GlaxoSmithKline) and RotaTeq (pentavalent, live rotavirus vaccine, from Merck). The use of rotavirus vaccines had been temporarily suspended in March 2010 while the FDA investigated the components of extraneous viruses, porcine circovirus 1 and 2 (PCV1 and PCV 2) in the vaccines. These viruses are not known to cause any infection or illness in people. All available evidence supports the safety and effectiveness of Rotarix and RotaTeq, which have been extensively studied, both before and after approval.
Rotarix is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children. RotaTeq is indicated for rotavirus gastroenteritis vaccination in infants 6–32 weeks of age.
For more information visit www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205547.htm.