Vaccine Suspension – A Decision with Potentially Deadly Consequences Worldwide
Mar 23, 2010
By Amy Pisani
After following up on the information provided by the CDC and FDA regarding the temporary suspension of the Rotarix vaccine due to contamination with a porcine type virus, it appears that there is no great concern that the virus will have any harmful effects on those who have been exposed to it.
FDA Commissioner Margaret Hamburg clarified that the FDA is not pulling Rotarix off the market, and that even asking doctors to suspend its use for the moment “was not an easy call.” After consulting with scientists at the National Institutes of Health and the Centers for Disease Control and Prevention, as well as officials at the Department of Health and Human Services, “We felt that the judicious thing to do was to make a pause and try to determine what this virus was doing in the vaccine and how it got there.”
The question now is whether the Merck vaccine product, Rotateq will be available in sufficient amounts during the temporary suspension of GlaxoSmithKline’s Rotarix vaccine.
As the U.S. suspends use of the vaccine, countries with higher burdens from this disease may decide to continue using the current vaccine. Why, because rotavirus causes nearly 500,000 deaths in children from developing nations each year! The decision to withhold vaccines in this case would most certainly result in deaths of children.
On the other side of the globe, before the vaccines were licensed here in the U.S. upwards of 50,000 children were hospitalized from rotavirus, resulting in nearly 100 deaths annually. A vaccine shortage in the U.S. is a definite possibility if the suspension extends for a lengthy period of time. We may once again be balancing a very dangerous seesaw: a shortage of vaccines resulting in exposure to deadly rotavirus on one side, countered by the possible contamination with what appears to be a benign virus on the other side. A tough decision for our country’s scientific experts indeed.
More information is available on the FDA site: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205539.htm
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