Monday, July 18, 2011

"The loss of the vaccine would be devastating. But we need to clean it up as soon as possible."

A majority of an advisory committee for the US Food and Drug Administration (FDA) today voiced support for the continued use of a contaminated rotavirus vaccine now under FDA suspension, arguing that the vaccine's benefits far outweigh the theoretical risks of the contaminant.

However, members of the Vaccines and Related Biological Products Advisory Committee also recommended studies of possible long-term risks of the vaccine in question, GlaxoSmithKline's Rotarix.

"On the whole, the vaccine seems to have a spectacular record for safety and efficacy," said committee member John Coffin, PhD, professor of molecular biology and microbiology at Tufts University in Boston, Massachusetts. "The loss of the vaccine would be devastating. But we need to clean it up as soon as possible."

"The benefits are so big the risks would have to be enormous to outweigh them," added Harry Greenberg, MD, senior associate dean for research at Stanford University School of Medicine in California. "So far, we see only theoretical risks."
John Coffin says reasonable things. I think I have to apologize to him.

But I have to disagree with Harry Greenberg: Just because you see only theoretical risks, doesn't mean that aren't actual risks. Yes, the benefits far outweigh the risks, but that is no reason to puh-puh the risks.

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