Initial U.S. Approval: 2006
RotaTeq is a vaccine indicated for the prevention of rotavirus gastroenteritis…
Following administration of a previously licensed live rhesus rotavirus reassortant vaccine, an increased risk of intussusception was observed.
In a post-marketing observational study in the US cases of intussusception were observed in temporal association within 21 days following the first dose of RotaTeq, with a clustering of cases in the first 7 days.
In worldwide passive post-marketing surveillance, cases of intussusception have been reported in temporal association with RotaTeq.
Shedding of vaccine virus was evaluated… RotaTeq was shed in the stools of… 8.9%… [of] vaccine recipients tested after dose 1. …shedding was observed as early as 1 day and as late as 15 days after a dose.
Transmission of vaccine virus strains from vaccinees to non-vaccinated contacts has been observed post-marketing.
Serious adverse events occurred in 2.4% of recipients of RotaTeq…
Across the clinical studies, 52 deaths were reported. There were 25 deaths in the RotaTeq recipients…
The most commonly reported cause of death was sudden infant death syndrome…
The most common serious adverse experience was bronchiolitis, which occurred in 1.4% of vaccine… recipients.
Post-Marketing Experience
Anaphylactic reaction
Intussusception (including death)
Hematochezia
Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID)
Urticaria
Angioedema
Kawasaki disease
Transmission of vaccine virus strains from vaccine recipient to non-vaccinated contacts.
RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The rotavirus parent strains of the reassortants were isolated from human and bovine hosts.
The reassortants are propagated in Vero cells [monkey kidney cells]…
Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum.
The exact immunologic mechanism by which RotaTeq protects against rotavirus gastroenteritis is unknown…
RotaTeq is a live viral vaccine that replicates in the small intestine…
RotaTeq has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.