SmartVax Discussion on the Rotavirus vaccine

Rotavirus infection causes a form of diarrhea.  In third world countries without adequate sanitation or health facilities, rotavirus can lead to death from dehydration.   However in the USA, rotavirus is a mild disease that is rarely fatal.

The rotavirus vaccine is given orally in three doses at 2, 4, and 6 months.  The original rotavirus vaccine, RotaShield, was pulled from the market after just two years of use in 2000 because of an increased risk of life-threatening intussusception (in which the one portion of the bowel slides into the next). The two current vaccines available, RotaTeq and Rotarix, were licensed in 2006 and 2008 respectively.  Both vaccines were shown in 2010 to contain unintended viral DNA sequences and in the case of Rotarix to contain live pig virus capable of replication.  Despite these safety concerns the vaccines remain on the recommended schedule (see Pig viruses in rotavirus vaccine).

Moreover, “GlaxoSmithKline’s rotavirus vaccine, called Rotarix, is associated with an increased risk of convulsions and pneumonia-related deaths in children taking it, according to a review by the U.S. Food and Drug Administration. …  The study, which enrolled about 63,000 children, found a statistically significant increase in convulsions and deaths related to pneumonia compared with a placebo, the review says.” http://www.bizjournals.com/triangle/stories/2008/02/11/daily36.html

From a public health perspective, this vaccine is useful in developing countries where inadequate health care and poor sanitation can cause diarrhea to become a life-threatening disease.  However, modern healthcare in the USA makes the risk of death from diarrhea very low (see Disease Risk – Rotavirus).  Given the low disease risk and the unknowns regarding the safety of the vaccine, parents in the USA might consider whether this vaccine’s benefits are worth its risks.