Rotavirus Vaccine Not Associated with Increased Risk of Intestinal Disorder in US Infants
“In this large, prospective postlicensure safety monitoring study of almost 800,000 doses of RV5 vaccine, with more than 300,000 first doses, we did not observe any increased risk of intussusception following RV5 vaccination. The introduction of rotavirus vaccines has had a substantial public health effect on severe rotavirus disease in U.S. infants. Although we cannot entirely exclude the possibility of a very low-level risk, the findings of our study strengthen the evidence base in favor of vaccination for effective control of severe childhood rotavirus disease,” the authors conclude.
###
(JAMA. 2012;307[6]:598-604. Available pre-embargo to the media at http://www.jamamedia.org)
Editor’s Note: This study was supported in part by the Vaccine Safety Datalink contract with AHIP, funded by the CDC. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.
Please Note: For this study, there will be multimedia content available, including the JAMA Report video, embedded and downloadable video, audio files, text, documents, and related links. This content will be available at 3 p.m. CT Tuesday, February 7 at this link.
Due to the recent information Intussusception was found to be a side effect of the first generation rotavirus vaccine (RotaShield®, Wyeth) that was available in the United States in 1998-1999. RotaShield was estimated to cause IS in 10-20 of every 100,000 doses given to infants, and was voluntarily withdrawn from the US market in October 1999. RotaShield was not used outside the US, however, as the historical incidence of IS is 2.5 to 3 times higher in infants in Australia than in the US, this would have translated to 25-60 cases of IS for every 100,000 doses of RotaShield if the vaccine had been used here.
Subsequently two new rotavirus vaccines, Rotarix and RotaTeq were developed, and both were tested in large studies designed to explore whether there was a risk of IS. In each of these placebo-controlled pre-registration studies, approximately 35,000 infants were given rotavirus vaccine, with no increased risk of IS observed. However, as large pre-registration safety studies may not always detect rare events, post-marketing studies have been undertaken in a number of countries.
This document has been prepared with the assistance of the Australian Technical Advisory Group on Immunisation (ATAGI) and the National Centre for Immunisation Research & Surveillance (NCIRS), based on a report prepared for the TGA by Professor John Carlin and Dr Katherine Lee of the Murdoch Childrens Research Institute.
###
Source: American Medical Association (AMA)