GSK Gains Approval for Rotavirus Vaccine in Infants; FDA Review Extended for Merck's Shingles Vaccine

GlaxoSmithKline PLC (London, England, www.gsk.com) and Merck & Co. Inc. (Whitehouse Station, NJ, www.merck.com) reported developments in their vaccine programs this week. Among the developments are European approval for GlaxoSmithKline’s rotavirus vaccine and an extension by the US Food and Drug Administration (Rockville, MD, www.fda.gov) for reviewing Merck’s application for a shingles vaccine.

GlaxoSmithKline receives European approval for rotavirus vaccine

The European Commission granted approval in the European Union of GlaxoSmithKline’s “Rotarix” vaccine for rotavirus in infants from the age of six weeks. Rotarix will be the first vaccine available to children in Europe for the prevention of gastroenteritis caused by rotavirus, said GlaxoSmithKline in a company release. 

FDA approval of Merck’s shingles vaccine delayed

FDA is extending the review period for Merck’s biologics license application (BLA) for a shingles vaccine to May 25, 2006. Merck filed the BLA for “Zostavax” (zoster vaccine live) in April 2005. FDA informed Merck that it is extending the review period in order to review additional information that Merck submitted during the review process.