GlaxoSmithKline’s rotavirus vaccine, Rotarix, has been associated with increased pneumonia-related deaths and other adverse reactions.
This FDA is considering approval of the oral vaccine, which prevents the most common cause of severe diarrhea and dehydration among infants and young children.
FDA staff said that an analysis of 11 studies revealed a statistically significant increase in deaths related to pneumonia. The largest study, which examined about 63,000 children, also found an increase in convulsions in children given the drug. Another study found an increased rate of bronchitis.