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Rotavirus vaccines carry increased short-term intussusception risk
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Both currently available rotavirus vaccines appear to carry increased risk of intussusception, mainly during the first 7 days after administration of the first dose, according to recent findings.
The risk was also found increase after administration of the second dose of the vaccines, but to a lesser degree, the researchers wrote.
In the meta-analysis, researchers evaluated data from postlicensure studies addressing the risk of intussusception following vaccination with the RV1 (Rotarix, GlaxoSmithKline) and the RV5 (RotaTeq, Merck) vaccine. Eligible studies were required to estimate risk for the 7-day period after rotavirus vaccination, assess the risk of dose 1 and dose 2 separately, include data obtained through active and/or passive surveillance for confirmed intussusception cases, and be published in a peer-reviewed journal or have a publicly available study report.
The researchers identified studies through systematic literature review and/or from presentations by the CDC to the Advisory Committee on Immunization Practices (ACIP) from 2006 to June 2013. The literature search included queries of Medline, Embase and Central databases.
The researchers identified five studies with data that met the criteria for inclusion in the study; additionally, an observed vs. expected study including non-confirmed cases was identified for a sensitivity analysis.
Log-transformed estimates of RR and corresponding 95% CIs were calculated from each eligible study; separate analyses were conducted for RV1 and RV5.
The researchers found that the overall estimate of intussusception RR during the 7 days after dose 1 for RV1 was 5.4 (95% CI, 3.9-7.4; three studies); this overall estimate for post-dose 1 of RV5 was 5.5 (95% CI, 3.3-9.3; three studies). A persistent but attenuated RR increase was observed in the 7 days post-dose 2 of both vaccines; for RV1 the RR was 1.8 (95% CI, 1.3-2.5; four studies) and for RV5, the RR estimate was 1.7 (95% CI, 1.1-2.6; three studies).
According to the researchers, these findings suggest that increased intussusception risk may be a class effect of the two currently available rotavirus vaccines.
“It remains to be fully determined whether the short-term increased risk of intussusception immediately following vaccination translates into an overall population-level increase in intussusception incidence during the first year of life and beyond, or whether there is a compensatory effect in the more distant post-vaccination period,” the researchers wrote. – by Jennifer Byrne
Disclosures: Rosillon reports being employed by and owning stock in GlaxoSmithKline. Please see the full study for a list of all other authors’ relevant financial disclosures.
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