By Barbara Loe Fisher
Today, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will vote on whether or not GlaxoSmithKline has proved that its new rotavirus vaccine (Rotarix) is safe and effective. An FDA staff analysis of the clinical trial data submitted by GSK, which was released on Feb. 15, revealed that Rotarix was associated with an increase in pneumonia-related deaths and convulsions. In addition, there were 27 cases of Kawasaki disease, which involves fever and blood vessel inflammation, a serious disease that has also been associated with Merck's rotavirus vaccine (RotaTeq).
Vicky Debold, PhD, RN, who is Director of Patient Safety for the National Vaccine Information Center (NVIC), has been appointed as the consumer voting member on VRBPAC and will be participating in the FDA Committee's discussion of the quality and quantity of the science presented by GSK in its efforts to secure a license for Rotarix. VRBPAC briefing documents on Rotarix may be viewed HERE.
Barbara Loe Fisher is with The National Vaccine Information Center.