Glaxo's new rotavirus vaccine has been linked to more pneumonia-related deaths and other reactions including bronchitis, according to a review by FDA staffers. The review was made in advance of an FDA advisory committee meeting to be hold this coming Wednesday to consider approval of the oral vaccine, which Glaxo wants to market to prevent rotavirus gastroenteritis, the most common cause of severe diarrhea among children.
In a review of 11 studies, the FDA staffers found at least one study in which there was a statistically significant increase in deaths related to pneumonia, compared with placebo, according to documents posted on the FDA's web site. Here is the agency briefing material and this is the Glaxo briefing document.
Hat tip to Reuters