[Pflienews] PharmFacts E-News Update: CDC purchasing 10 MM doses of questionable vaccine

[PFLI PharmAid Center]

*PharmFacts E-News Update -- 16 Jan 2008 AD

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http://www.fdanews.com/newsletter/article?articleId=103084&issueId=11210 
<http://www.fdanews.com/newsletter/article?articleId=103084&issueId=11210>
 


  DAnews Drug Daily Bulletin

*Jan. 15, 2008*  *| Vol. 5 No. 9*
 

*CDC Purchasing 10 Million Doses of Gardasil*

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 
<http://fs1.fbo.gov/EPSData/HHS/Synopses/2965/2008-N-19196/VFC2008Solicitation.doc>.


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