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Rotarix° oral vaccine: wrong-route errors

The Rotarix° oral vaccine applicator has a deceptive syringe-like appearance, which has resulted in intramuscular injections being given in error.

Rotarix° and Rotateq° are vaccines marketed for the prevention of rotavirus gastroenteritis in infants. Whereas most infant vaccines are injectable, these two vaccines are intended to be administered orally.

Despite changes in the patient leaflet since 2007, with diagrams clearly showing oral use only, the Rotarix° vaccine is still presented in a syringe form, and it is possible to force a needle into the tip; this leads to confusion.

The Pharmacovigilance Centre in Tours, France, reported 4 cases of intramuscular administration of Rotarix° vaccine in France between November 2014 and April 2017. In two cases, infants experienced serious adverse reactions with diarrhoea and the presence of blood in the stools.

There have been no reported cases of injection by mistake with Rotateq° vaccine, which is a ready-to-use oral solution in a small, single-dose tube with a mouthpiece clearly designed for oral administration. It is therefore possible to opt for a better-designed device.

An oral formulation of Rotarix° in a flexible tube is already marketed in Spain, Portugal and Sweden, but not in France.

Because of the risk of serious intestinal adverse effects, vaccination against rotavirus is not recommended in France, and the risk of wrong-route error with sometimes severe consequences makes its harm-benefit balance even more uncertain. However, when vaccination is required, it is better to choose Rotateq° over Rotarix°, because of its more appropriate packaging and lower risk of administration error.

©Prescrire 1 March 2020

"Rotarix° oral vaccine: still being mistakenly administered by intramuscular injection" Prescrire Int 2020; 29 (213): 69-70. (Pdf, subscribers only).

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