FDA Panel Approves Rotarix Safety 11-1

FDA Panel Approves Rotarix Safety 11-1
Consumer Member Vicky Debold Votes "NO" on Proof of Safety by GSK

by Barbara Loe Fisher

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.

"GlaxoSmithKline Plc's infant vaccine to prevent diarrhea caused by the rotavirus appears safe and effective, based on available data, U.S. advisers said on Wednesday.........In a briefing prepared for the meeting, FDA staff had noted a statistically significant increase in deaths related to pneumonia compared with placebo in Glaxo's largest trial. The panel was unanimous the vaccine appeared effective and voted 11-1 that it appeared safe.....Vicky Debold, patient safety director at the National Vaccine Information Center, was the sole panel member to vote that the data does not support the vaccine's safety. She noted the infants studied were all healthy and asked: "What happens when this vaccine is given to children in the real world?" - Kim Dixon, Reuters, (February 20, 2008)
http://www.guardian.co.uk/feedarticle?id=7324731

"Steven Rosenthal, an FDA medical officer who presented the agency's review of the vaccine, said there was a higher rate of pneumonia-related deaths and convulsions among vaccinated infants in one of the main studies. The overall death rate from any cause, however, was similar between infants given the vaccine and those in placebo groups. In total there were 118 deaths among all infants in the studies with 19 pneumonia related-deaths among those receiving the vaccine and 10 among those not receiving it. He said if Rotarix is approved in the U.S., Glaxo would conduct a post-marketing study of the vaccine to monitor for potential side effects such as pneumonia, convulsions and intussusceptions. In briefing documents prepared for Wednesday's meeting, an FDA staff review said it wasn't clear what role, if any, the vaccine played in the risk, while Glaxo officials said there didn't appear to be any link to the vaccine. Clare Kahn, Glaxo's North American vice president of regulatory affairs, said, "The risk-benefit ratio is favorable for the intended population." One panel member voted against the vaccine on safety grounds. Vicky Debold, a nurse and the panel's consumer representative, said she was concerned about not just the pneumonia-related deaths but the overall death rate." - Jennifer Corbbett Dooren, Wall Street Journal, (February 20, 2008)
http://online.wsj.com/article/SB120354110915280781.html?mod=googlenews_wsj