Increased risk of intussusception link to rotavirus vaccines
The risk of intussusception (IS) was found to increase by as much as tenfold for RotaTeq (Merck/CSL) and sevenfold for Rotarix (GSK).
This prompted the TGA to add the new information on the risks to the post-marketing adverse event sections of the product information for both vaccines.
The final study extended an interim study to include data from six jurisdictions for a three-year period from July 2007 to June 2010.
Cases of IS in children 1–12 months of age were identified from hospital admissions data and vaccination status for each case was obtained from the Australian Childhood Immunisation Register (ACIR).
Of 306 cases of IS, 260 were recorded to have received rotavirus vaccination. After the first dose of Rotarix, the relative incidence of IS was 6.8 and 3.5 for periods of 1–7 and 8–21 days respectively, and 9.9 and 6.3 with RotaTeq.
There was also nearly three times the risk of IS 1–7 days