more deaths among the healthy infants who received Rotarix compared to those who received a placebo.

NVIC's Director of Patient Safety, Vicky Debold, Ph.D, RN, who is the consumer voting member on the FDA Vaccines and Related Biological Products Advisory Committee, cast the sole dissenting "NO" vote when the Committee was asked whether GlaxoSmithKline's pre-licensure clinical trials had proved that rotavirus vaccine (Rotarix) is safe to give to infants. The FDA Panel voted unanimously that GSK had proven effectiveness but voted 11-1 on the safety question.

Debold noted that there were more deaths among the healthy infants who received Rotarix compared to those who received a placebo. She pointed out that the clinical trials did not inlude premature, sick and otherwise biologically compromised infants and asked "What is going to happen when this vaccine is given to children in the real world?" An FDA staff report analyzing GSK data revealed a statistically significant increase in deaths related to pneumonia among infants who got Rotarix versus the placebo.

Rotarix vaccine will directly compete with Merck's Rotateq vaccine for market share. Rotateq, a genetically engineered hybrid live virus vaccine containing human and bovine strains, has been associated with bowel blockage (intussusception). Bowel blockage does not appear to be a problem for live virus Rotarix, which contains genetically engineered human rotavirus strains, although serious adverse events associated with the new vaccine have included not only pneumonia and death but also bronchitis and convulsions.