Rotavirus vaccine not associated with intussusception in Indian study
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The use of a three-dose, monovalent oral rotavirus vaccine — Rotavac (Bharat Biotech International) — was not associated with an increased risk for intussusception during a 3-year trial in India.
Samarasimha N. Reddy, MD, from the Wellcome Trust Research Laboratory, and colleagues enrolled 970 infants aged between 28 to 365 days with intussusception in an active surveillance study at 27 hospitals in India. They included 589 of the infants in a self-controlled case-series analysis and checked vaccination records to determine who had received the rotavirus vaccine.
According to the study, intussusception was more common among male infants than female infants (2:1). Ileocolic intussusception was the most common type of intussusception, affecting 85% of infants (n = 498). Ileoileal intussusception was observed in 33 children (6%).
Among all of the infants, 289 (49%) received all three doses of the vaccine, 55 (9%) received two doses and 33 (6%) received one dose. There were 212 (36%) infants who did not receive any of the doses.
Of the 377 infants who received the first dose, 330 (88%) received the oral polio vaccine on the same day. Among the 344 and 289 infants who received the second and third doses of the rotavirus vaccine, 300 (87%) and 240 (83%), had also received the second and third doses of the oral polio vaccine.
After the first dose of the vaccine, two cases of intussusception occurred in the 1-to-7-day risk window — a relative incidence of 0.83 (95% CI, 0-3). Two cases occurred in the 8-to-21-day risk window — a relative incidence of 0.35 (95% CI, 0-1.09).
Following the second dose, four cases of intussusception occurred in the 1-to-7-day risk window — a relative incidence of 0.86 (95% CI, 0.20-2.15), and an additional 15 cases occurred in the 8-to-21-day risk window, for a relative incidence of 1.23 (95% CI, 0.60-2.10).
After the third dose, 15 cases of intussusception occurred in the 1-to-7-day risk window — a relative incidence of 1.65 (95% CI, 0.82-2.64), and an additional 22 cases occurred in the 8-to-21-day risk window for a relative incidence of 1.08 (95% CI, 0.69-1.73).
Perspective
Back to TopPaul A. Offit, MD
It is a different vaccine than the two vaccines being used in the United States. RotaShield was introduced in the late 1990s and was found to be a rare cause of intussusception in roughly one per 30,000 patients. When RotaTeq (Merck) and then Rotarix (GlaxoSmithKline) were introduced in 2006 and 2008, respectively, eventually both were also shown to be even rarer causes of intussusception in the vicinity of anywhere from 1.5 to 5 per 100,000 patients.
So, you basically have three different vaccines, all of which have different strategies that all caused rare cases of intussusception. Now here, in India, their vaccine did not show intussusception. The question is, why? Is it because it is biologically even different from the other three? Is that why it did not seem to cause it? Or is it that you need to conduct larger studies to find what is a very rare side effect?
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