GlaxoSmithKline Plc's rotavirus vaccine is associated
with increased pneumonia-related deaths and other adverse
reactions, U.S. regulatory staff said in recently posted
The review comes ahead of a Food and Drug Administration
advisory meeting 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.
That study, which enrolled about 63,000 children, also
found an increase in convulsions in children given the
drug, named Rotarix. Another study found an increased
rate of bronchitis, compared with placebo.
In a conclusion section, the FDA documents noted the
pneumonia-related deaths and convulsions, but did not
appear to make a recommendation to the advisory panel.
That expert panel will weigh the staff review, but makes
its own recommendation, which is typically followed by
Bernstein Research analyst Tim Anderson said safety issues
could mar his current forecasts for the drug of reaching
sales of $1.3 billion by 2012.