CDC reports injections of oral rotavirus vaccine

March 11, 2014

Incidences involving oral vaccine for protecting children against rotavirus gastroenteritis mistakenly being injected are increasing, according to the Institute for Safe Medication Practices (ISMP).

 

Incidences involving oral vaccine for protecting children against rotavirus gastroenteritis mistakenly being injected are increasing, according to the Institute for Safe Medication Practices (ISMP).

The Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System notes 39 reports of accidental injection of the oral vaccine, which makes the vaccine ineffective. Thirty-three cases occurred with the Rotarix vaccine (GlaxoSmithKline; Brentford, Middlesex, UK), while 6 cases were associated with RotaTeq (Merck; Whitehouse Station, New Jersey).

The Rotarix vaccine comes with a prefilled oral applicator syringe that holds the diluents for reconstitution of the lyophilized vaccine vial. Then, the reconstituted liquid vaccine is supposed to be drawn back into the oral applicator via the transfer device and given orally, according to ISMP.

“Errors have happened when the Rotarix vaccine vial is thought to be a vial of injectable medicine, the Rotarix oral applicator syringe is thought to be a parenteral syringe, there is inadequate training of staff, or the package insert is difficult to read or isn’t reviewed,” ISMP wrote in the February 2014 issue of ISMP Medication Safety Alert! Community/ Ambulatory Care Edition.

Unfortunately, the United States is the only country where Rotarix is not available as a ready-to-use liquid. To avoid this error-until it is available as a ready-to-use vaccine-ISMP suggests using the RotaTeq vaccine instead.

Of course, pharmacies that supply physician offices, clinics, and other ambulatory practices should make sure their staffs are aware of this potential problem with using Rotarix. In addition, both the CDC and ISMP have brought the errors to the attention of the vaccine manufacturers and the US Food and Drug Administration. The CDC continues to recommend that all US infants receive either of the 2 rotavirus vaccines licensed for use in the United States.

 

To get weekly clinical advice for today's pediatrician, subscribe to the Contemporary Pediatrics eConsult.