FDA update: Rotavirus vaccine is not for infants with severe combined immunodeficiency disease

September 1, 2011

The US Food and Drug Administration has ordered a safety labeling change for RotaTeq oral solution.

The US Food and Drug Administration (FDA) has ordered a safety labeling change for RotaTeq (live pentavalent rotavirus vaccine) oral solution.

Adverse gastrointestinal reactions including gastroenteritis with severe diarrhea and prolonged shedding of vaccine virus have been reported in infants who received the vaccine and later were identified as having severe combined immunodeficiency disease (SCID).

RotaTeq oral vaccine is indicated for the prevention of gastroenteritis in infants and children caused by rotavirus serotypes G1, G2, G3, G4, and P1. It is administered in a 3-dose series to infants between 6 and 32 weeks of age.