Kristie McNealy, MD

US officials released a report on Friday which examined the findings of 11 trials of a new oral rotavirus vaccine from GlaxoSmithKline. The report stated that the vaccine was effective at preventing rotavirus infection. Unfortunately, it was also linked to a significant increase in pneumonia deaths in children, as well as an increase in convulsions and bronchitis.

Rotavirus is one of the most common causes of severe diarrhea in children, resulting in 55,000 hospitalizations for dehydration in the US each year. This isn’t the first time there has been a problem with a vaccine against rotavirus. In 1999, a rotavirus vaccine made by Wyeth was pulled off the market because it was associated with intussusception, a condition where one portion of the intestine telescopes into a nearby portion, causing an intestinal blockage. Analysis of the studies on Rotarix showed no association between the new vaccine and this serious intestinal complication.

If you’re worried that your baby may have received this vaccine, don’t panic. There is a different oral rotavirus vaccine on the market in the US called RotaTeq, which is made by Merck, and has been FDA approved since February 3, 2006. Ironically, that happens to be the same week my own daughter was discharged from the NICU, where her stay was extended by serious complications from a rotavirus infection.  Originally, I was angry that we missed out getting the vaccine by such a narrow window, but then cases of intussusception began cropping up in infants who received the vaccine after the trial.

The Food and Drug Administration advisory meeting is scheduled to discuss the possible approval of GlaxoSmithKline Plc’s new rotavirus vaccine, Rotarix, on Wednesday, February 20th. Hopefully they will decide that in the case of Rotarix, the benefits do not outweigh the risks, at least in places where rehydration in a hospital setting is usually feasible.

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