FDAnews Drug Daily Bulletin

CDC Purchasing 10 Million Doses of Gardasil

Jan. 15, 2008

The Centers for Disease Control and Prevention’s (CDC) latest round of acquisitions under its Vaccines for Children program includes the purchase of 10 million doses of Merck’s human papillomavirus (HPV) vaccine Gardasil, according to CDC solicitation documents.

The agency’s planned purchase is the same as its 2007 procurement.

Merck is the only FDA-approved manufacturer of quadrivalent HPV, which is called for in the procurement specifications. Gardasil (HPV quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) protects against four different strains of the virus, unlike GlaxoSmithKline’s (GSK) Cervarix (HPV, AS04 adjuvant-adsorbed).

Cervarix, approved in Europe, provides 100 percent protection against strains 16 and 18 only, according to the company. Although GSK has indicated that the product provides broader protection against cancer-causing HPV strains, the firm’s marketing authorization from the European Medicines Agency only references strains 16 and 18.

The FDA recently issued a complete response letter for Cervarix, requesting more information about the product. Results from a head-to-head trial comparing Cervarix with Gardasil could be available later this year.

The anticipated performance period of the contract starts April 1 and continues through March 31, 2009. Only measles, mumps and rubella and Hib vaccines are subject to statutory price ceilings. Bids close Jan. 28. The solicitation can be accessed at fs1.fbo.gov/EPSData/HHS/Synopses/2965/2008-N-19196/VFC2008Solicitation.doc.