Intussusception risk with 116E rotavirus vaccine in Vellore, South India.

We congratulate John and colleagues for their surveillance of ntussusception during the 116E rotavirus vaccine trial [1]. They oint out that it is critical to be vigilant to the risk of intussusception to determine if there are safety signals of a larger magnitude than urrently expected that may preclude licensure”. Rotasheild was licensed after a trial involving 14,687 patients. n this trial there was an excess of 3 cases of intussusception per 0,000 children vaccinated. All the intussusceptions were among nfants who received the second or third dose of the vaccine [2]. ost-licensure, after 9 cases of intussusceptions were reported, nalysis revealed an excess risk of 1–2 intussusceptions per 10,000 accinated. Rotasheild was then withdrawn from the market [3]. After Rotasheild was withdrawn, the US FDA approved another otavirus vaccine – RotaTeq based on results of a much larger trial mong 72,324 infants. No excess in intussusception was noted in he RCT but post-marketing surveillance revealed a small increase n risk of intussusception of 0.15/10,000 [4]. In the study reported by John [1] the vaccine was tested in nly 6719 infants (4532 received vaccine; 2187 were controls). ltrasound evidence of intussusception was found in 17 who had eceived the 116E vaccine (3.75/1000 or 37.5/10,000) and in 6 abies receiving placebo (2.636/1000 or 26.36/10,000). There was n excess of 11 cases of intussusception per 10,000 vaccinated. his is 5–10 times higher than the risk of intussusception with otasheild vaccine (which was withdrawn from the market) and early 70 times higher than the risk of intussusception with the urrent, internationally licensed vaccine, RotaTeq. Intussusception rates varied in the different regions studied by