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Notes from the Field: Administration Error Involving a Meningococcal Conjugate Vaccine--United States, March 1, 2010-September 22, 2015. | LitMetric

AI Article Synopsis

  • Menveo is a conjugate vaccine developed by GlaxoSmithKline for preventing invasive meningococcal disease caused by specific serogroups of Neisseria meningitidis, recommended for adolescents and certain immunocompromised individuals.
  • The vaccine requires a two-component preparation: a lyophilized MenA component and a liquid MenCYW-135 component, which need to be combined correctly before intramuscular administration to ensure efficacy.
  • A recent incident raised safety concerns when a provider only administered the lyophilized component; the CDC and FDA then investigated reports of improper administration using the Vaccine Adverse Event Reporting System to assess potential adverse events.

Article Abstract

Menveo (GlaxoSmithKline, previously Novartis AG) is a conjugate vaccine that was recommended in October 2010 for routine use in adolescents (preferably aged 11 or 12 years, with a booster at 16 years), and among persons aged 2 through 54 years with certain immunosuppressive conditions, to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (1). These recommendations have since been updated (2). Menveo is supplied in two vials that must be combined before administration. The MenA lyophilized (freeze-dried) component must be reconstituted with the MenCYW-135 liquid component (Figure). To administer the vaccine, the liquid component is drawn into a syringe, and used to reconstitute the lyophilized component. The resulting solution is administered by intramuscular injection. Failure to prepare Menveo as directed by the manufacturer's instructions can lead to lack of protection against the intended pathogens (N. meningitidis serogroups A, C, Y, and/or W-135) (3). Recently, an immunization provider administered only the lyophilized component of Menveo, subsequently administered a properly prepared dose of Menveo to the same patient, and asked CDC if this practice was safe. This question prompted CDC to search the Vaccine Adverse Event Reporting System (VAERS) database for reports during March 1, 2010-September 22, 2015, of only one component of Menveo being administered. Additionally, to more broadly identify disproportional reporting of adverse events in general following Menveo immunization compared with other vaccines in VAERS (including errors in vaccine preparation and administration), the Food and Drug Administration performed data mining with empiric Bayesian methods (4).

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Source
http://dx.doi.org/10.15585/mmwr.mm6506a4DOI Listing

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