It is a LIVE vaccine so it can shed to others:
Shedding was evaluated among a subset of subjects in REST 4 to 6 days after each dose and among all subjects who submitted a stool antigen rotavirus positive sample at any time. RotaTeq was shed in the stools of 32 of 360 [8.9%, 95% CI (6.2%, 12.3%)] vaccine recipients tested after dose 1; 0 of 249 [0.0%,95% CI (0.0%, 1.5%)] vaccine recipients tested after dose 2; and in 1 of 385 [0.3%, 95% CI (<0.1%,1.4%)] vaccine recipients after dose 3. In phase 3 studies, shedding was observed as early as 1 day and as late as 15 days after a dose. Transmission was not evaluated. There is a theoretical risk that the live virus vaccine can be transmitted to non-vaccinated contacts. The potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural rotavirus.
RotaTeq contains five human-bovine (cow) reassortment rotaviruses out of many more for which there is no vaccine for.
There were no long term studies of RotaTeq in combination with 7 other vaccines, even though RotaTeq is given in addition to them.
The number of cases of intussusception in the clinical trials of the Rotateq was similiar to the old Rotashield which was recalled.
The Food and Drug Administration (FDA) approved a revised label for RotaTeq®, a rotavirus vaccine manufactured by Merck and Co., Inc., to include information on reports of Kawasaki syndrome occurring before and after the vaccine’s licensure in February 2006. FDA has not made any changes to its indications for use of RotaTeq nor has it issued new or revised warnings or precautions. Likewise, the Centers for Disease Control and Prevention (CDC) has not made any changes in its recommendations regarding the use of RotaTeq. Healthcare providers and parents should remain confident in using RotaTeq in infants.
The number of cases of intussusception in the clinical trials of the Rotateq was similiar to the old Rotashield vaccine which was recalled.
Rotarix: was approved in 2008.
Just 2 months before the approval:
FDA ties pneumonia deaths to infant vaccine.
GlaxoSmithKline Plc’s rotavirus vaccine is associated with increased pneumonia-related deaths and other adverse reactions, U.S. regulatory staff said in documents posted on Friday.
FDA staff said its analysis of 11 studies revealed that in the largest trial, there was a statistically significant increase in deaths related to pneumonia compared with placebo, documents posted on the FDA’s Web site said.
That study, which enrolled about 63,000 children, also found an increase in convulsions in children given the drug, named Rotarix. Another study found an increased rate of bronchitis, compared with placebo. (Reuters 2/15/2008)