Ahead of the Bell: Glaxo Vaccine

February 20, 2008

I posted this story the other day, but it's interesting that this article

says that Glaxo moved the goalposts during the study.

Updated 6:53 a.m. ET Feb. 20, 2008

WASHINGTON - Government advisers will consider Wednesday whether a

GlaxoKline vaccine should be approved even though the company's study

of the anti-diarrhea drug did not follow U.S. Regulations.

The British drug maker has asked the Food and Drug Administration to approve

Rotarix to prevent rotavirus, the leading cause of diarrhea in infants. The

FDA's outside panel of vaccine experts is scheduled to make a recommendation

on the product at a meeting Wednesday. The FDA is not required to follow the

experts' recommendations, though it usually does.

FDA reviewers found that Rotarix was effective at preventing rotavirus in

children as young as 24 weeks old, according to government documents posted

online last week. It also reported that a study of Rotarix did not show

life-threatening intestinal problems seen with older vaccines for the same

virus.

However, the FDA noted that Glaxo adjusted the study's safety goal in the

middle of the trial _ a change not allowed under U.S. Regulations. The

company conducted the 63,000-patient study in 11 foreign countries, most in

Latin America.

" Changing the primary objective while the trial is ongoing could potentially

compromise the integrity of the study, " the FDA said.

Other side effects reported in studies of the drug included pneumonia and

convulsions.

About 55,000 U.S. Children are hospitalized each year due to the rotavirus,

according to the Centers for Disease Control.

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