The consumer member of the FDA Vaccine safety review committee gave a thumbs down on approval of the new rotavirus vaccine (Rotarix) for infants. The vaccine is for diarrhea caused by the rotavirus.

Vicky Debold as registered nurse and Ph. D was not convinced that the clinical trials of the new infant vaccine showed it was safe. The data showed more deaths among the healthy infants who received Rotarix compared to those who received a placebo.

Npr did the safety trails include premature, sick or otherwise compromised infants, a significant shortcoming in the study.

Despite these important safety concerns, Diebold was the lone dissenter on the panel which voted for approval 11-1.

According to Steven Rosenthal, an FDA medical officer who presented the agency’s review of the vaccine, there was a higher rate of pneumonia- related deaths and convulsions among vaccinated infants in one of the main studies. In all 11 studies involving 75,000 children were done for the new vaccine.

The new vaccine called Rotarix will directly compete with Merck’s Rotateq vaccine for market share. The Merck vaccine is has been associated with bowel blockage, which does not appear to be a problem for new vaccine.

Source
FDA