WASHINGTON - GlaxoSmithKline Plc's rotavirus vaccine is associated with increased pneumonia-related deaths and other adverse reactions, U.S. regulatory staff said in documents posted on Friday.
The review comes ahead of a Food and Drug Administration advisory meeting next Wednesday to consider approval of the oral vaccine to prevent the most common cause of severe diarrhea and dehydration among infants and young children in the world.
FDA staff said its analysis of 11 studies revealed that in the largest trial, there was a statistically significant increase in deaths related to pneumonia compared with placebo, documents posted on the FDA's Web site said.
