News Feature | February 13, 2014

CDC Report Says Accidental Injection Of Oral Rotavirus Vaccine More Frequent In GSK Than Merck Products

Source: Pharmaceutical Online

By Estel Grace Masangkay

The Centers for Disease Control and Prevention have released a recent report about mistakes in administrating oral rotavirus vaccine in the U.S. Injecting oral rotavirus vaccine renders it ineffective. The CDC examined reports of accidental injection submitted to the Vaccine Adverse Event Reporting System (VAERS), run by both the CDC and the FDA. The report showed 39 errors by injection instead of oral administration of the vaccine.

According to the report, oral rotavirus vaccine administration errors were more frequent with GlaxoSmithKline’s Rotarix (33 out of 39 reports) than with Merck’s RotaTeq (6 out of 39 reports). RotaTeq and Rotarix are the only two major oral live vaccines for rotavirus in the U.S.

No other oral vaccines aside from rotavirus vaccines are routinely administrated to children in the U.S. since the use of live oral poliovirus was ruled out in 2000. The resulting lack of experience in administration of oral vaccines by healthcare providers was cited as one of the reasons for the errors.

Merck product RotaTeq comes in liquid form in a squeeze applicator. GSK’s Rotarix, on the other hand, is manufactured in a dried out form, requiring mixture of the vaccine into a liquid before administrating it to children.

Rotarix is available in a prefilled oral applicator syringe containing the diluent. After the healthcare provider mixes the vaccine, it is required to be drawn back into the oral applicator to be given orally. Errors occur when the healthcare provider mistakenly assumes the product is meant for injection or confuses the Rotarix oral applicator for an injection syringe.

GSK’s Rotarix is available in a ready to use liquid form, similar to Merck’s RotaTeq in Canada and outside the U.S. Until liquid Rotarix products are rolled out in the U.S., healthcare providers may consider using Merck’s product RotaTeq instead to avoid confusion since the CDC recommended either of the two products can be given.