FDA Committee Votes Today on New Rotavirus Vaccine

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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 at:

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2008年2月27日，葛兰素史克公司（GSK）获得许可在欧洲上市销售轮状病毒疫苗Rotarix。Rotarix将是在欧洲获批的第一个可用于预防儿童轮状病毒引起的肠胃炎的轮状病毒疫苗。葛兰素史克计划尽快在全欧洲上市该产品。

    Rotarix能预防轮状病毒的G1P、G3P和G9P株。临床试验显示，Rotarix不会增加肠套叠的发生几率。肠套叠问题曾导致惠氏公司于1999年撤出其研发的轮状病毒疫苗RotaShield。

    GSK于1997年从Avant公司购得了Rotarix的全球销售权。Rotarix目前已在全球31个国家上市，峰值销售额估计可达到18亿美元。