Benefits of rotavirus vaccines outweigh intussusception risk

IDSA 49th Annual Meeting

BOSTON — The estimated benefit–risk ratio for rotavirus vaccination and hospitalizations due to vaccination-associated intussusception was more than 800 to 1, according to findings presented at the IDSA 49th Annual Meeting.

Rishi Desai, MD, MPH, an epidemic intelligence service officer in the division of viral diseases at the CDC, presented data from the 14 Latin American countries currently employing rotavirus immunization. “The benefits of rotavirus vaccine far outweigh the intussusceptions risk, and continued vaccination will save thousands of lives and hospitalizations every year in Latin America,” he told Infectious Diseases in Children. “Physicians have to be aware of the benefits and risks of vaccination so that they can offer these life-saving interventions to their patients.”

Health officials have recently been obliged to weigh the risks and benefits of rotavirus immunization in light of recent postlicensure identification of an increased risk for intussusception associated with it. The current trial compared two estimates in the 14 countries: the excess intussusception risk associated with the vaccine and the number of hospitalizations and deaths expected to be averted through vaccination.

Postlicensure findings from Mexico and Brazil were used to create intussusception RR ratio estimates. Compared with baseline, the RR for intussusception in those cohorts 1 week after the first dose was 5.3 (95% CI, 3-9.3). A week after the second dose, the RR was 2.6 (95% CI, 1.3-5.2).

Assuming an aggregate birth cohort of 9.5 million infants from the 14 countries studied, for each year of the first 5 years of life, the rotavirus vaccine would be expected to prevent 137,498 hospitalizations and 2,523 deaths due to rotavirus. However, there would be 162 additional hospitalizations and 10 additional deaths due to intussusception. The resulting benefit-to-risk ratio is 846 to 1 for hospitalizations and 255 to 1 for death.

“Reassuringly, the level of intussusception risk with the new vaccines (Rotarix, GlaxoSmithKline; and RotaTeq, Merck) is far lower than that with the previous vaccine, Rotashield (Wyeth),” Desai said.

The disease burden and vaccine efficacy data were combined with global natural intussusception and country-specific diptheria, tetanus toxoids and pertussis vaccination coverage rates to estimate the extent of rotavirus vaccine coverage.

Disclosure: Dr. Desai reports no relevant financial disclosures.

For more information:

Desai R. #330. Presented at: IDSA 49th Annual Meeting; Oct. 20-23, 2011; Boston.

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