Initial U.S. Approval: 2008
ROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis…
Rotavirus shedding in stool occurs after vaccination with peak excretion occurring around Day 7 after Dose 1.
[V]accinees transmit vaccine virus to healthy seronegative contacts…
Following administration of a previously licensed oral live rhesus rotavirus-based vaccine, an increased risk of intussusception was observed.
The risk of intussusception with ROTARIX was evaluated in a pre-licensure randomized, placebo-controlled safety study (including 63,225 infants) conducted in Latin America and Finland. No increased risk of intussusception was observed in this clinical trial following administration of ROTARIX when compared with placebo*.
In a postmarketing, observational study conducted in Mexico, cases of intussusception were observed in temporal association within 31 days following the first dose of ROTARIX, with a clustering of cases in the first 7 days.
Other postmarketing observational studies conducted in Brazil and Australia also suggest an increased risk of intussusception within the first 7 days following the second dose of ROTARIX.
In worldwide passive postmarketing surveillance, cases of intussusception have been reported in temporal association with ROTARIX.
Serious adverse reactions occurred in 1.7% of recipients of ROTARIX…
During the entire course of 8 clinical studies… there were 68… deaths following administration of ROTARIX… The most commonly reported cause of death following vaccination was pneumonia, which was observed in 19… recipients of ROTARIX…
Kawasaki disease has been reported in 18… recipients of ROTARIX… the time of onset after study dose ranged 3 days to 19 months.
[T]here was 1 fatal SAE [Serious Adverse Event] (with diagnosis of sudden infant death syndrome) following administration of ROTARIX liquid formulation…
Postmarketing Experience
– Intussusception (including death), recurrent intussusception (including death), hematochezia, gastroenteritis with vaccine viral shedding in infants with SCID.
– Idiopathic thrombocytopenic purpura.
– Kawasaki disease.
[P]re-term infants were followed for SAEs up to 30 to 90 days after Dose 2. SAEs [Serious Adverse Events] were observed in 5.2% of recipients of ROTARIX…
The rotavirus vaccine strain is propagated on Vero cells [monkey kidney cells].
In the manufacturing process, porcine-derived materials are used. Porcine circovirus type 1 (PCV-1) is present in this ROTARIX formulation. PCV-1 is not known to cause disease in humans.
The liquid diluent contains… xanthan**.
The exact immunologic mechanism by which ROTARIX protects against rotavirus gastroenteritis is unknown…
ROTARIX contains a live, attenuated human rotavirus that replicates in the small intestine and induces immunity.
ROTARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.