TY  - JOUR
T1  - ROtavirus vaccine
AU  - Kuehn BM
Y1  - 2010/12/22
N1  - 10.1001/jama.2010.1816
JO  - JAMA
SP  - 2687
EP  - 2687
VL  - 304
IS  - 24
N2  - 
In September, the US Food and Drug Administration announced a change in the label for Rotarix to indicate an increased risk of intussusception among infants during the month after the first dose (http://tinyurl.com/25589oc). The information was based on preliminary data from a postmarketing trial of the vaccine in Mexico, which found an 1.8-fold increased risk of intussusception. On October 28, the CDC's Advisory Committee on Immunization Practices (ACIP) evaluated data from this trial and other postmarketing studies in Latin America and Australia that have suggested an increased risk of intussusception shortly after vaccination with Rotarix or RotaTeq. So far, a study of more than 800 000 doses of RotaTeq in the United States through the Vaccine Safety Datalink (a collaborative effort between the CDC and 8 managed care organizations) has not found an increased risk. The ACIP noted in a statement that if an increased risk of intussusception exists in the United States similar to that seen in the Mexican study, about 1 case of intussusception would occur per 100 000 US infants receiving the vaccine.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2010.1816
UR  - http://dx.doi.org/10.1001/jama.2010.1816
ER  -