(HealthDay)—Bell's palsy is the only prespecified adverse event associated with the MenACWY-CRM quadrivalent meningococcal conjugate vaccine, according to a study published online Dec. 26 in Pediatrics.
Hung-Fu Tseng, Ph.D., from the Southern California Permanente Medical Group in Pasadena, and colleagues evaluated data from 48,899 individuals, aged 11 to 21 years, receiving MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, between Sept. 30, 2011, and June 30, 2013. Electronic health records were used to identify 26 prespecified events of interest (EOIs) for up to one year after vaccination.
The researchers found that no cases were observed in the risk window for 14 of 26 EOIs. The relative incidence (RI) for Bell's palsy was statistically significant at 2.9 (95 percent confidence interval, 1.1 to 7.5). An increased risk for Bell's palsy in subjects receiving concomitant vaccines (RI, 5.0; 95 percent confidence interval, 1.4 to 17.8) was seen in stratified analyses, but no increased risk was seen for those without concomitant vaccine (RI, 1.1; 95 percent confidence interval, 0.2 to 5.5).
"The association needs further investigation as it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy," the authors write.
Several authors disclosed financial ties to Novartis Vaccines and Diagnostics (now part of GlaxoSmithKline Vaccines), which funded the study.
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