FDA Committee Recommends Approval of HPV Vaccine

The FDA's Vaccines and Related Biological Products Advisory Committe voted unanimously on Thursday that Merck's Gardasil vaccine to protect against certain types of HPV infection (and, by extension, cervical cancer) is safe and effective for women ages 9-26. The targeted HPV strains are thought to be responsible for about 70% of cervical cancers worldwide. The disease kills 290,000 women worldwide each year (3,500 in the U.S.), and it is estimated that approximately $1.7 billion is spent in the U.S. each year on cervical cancer treatment. The advisory document is not yet up on the FDA website - see the resources below for additional information. A final FDA approval decision is expected by June 8. One hurdle to vaccination is the anticipated cost of the vaccine, which may be in the $300-$500 range.

Sources:

• National Cancer Institute:
  
  • Snapshot of Cervical Cancer (PDF)
    
  • Human Papillomaviruses and Cancer: Questions and Answers
    
  • Cervical Cancer Prevention
    
  • General Information About Cervical Cancer
    
  • Cervical Cancer Trial Results
  
  
• News Sources:
  
  • Panel recommends FDA approval of cervical cancer vaccine - CNN
    
  • Panel backs vaccine for cervical cancer - New York Times
    
  • FDA Advisory Panel Unanimously Determines HPV Vaccine Gardasil To Be Safe, Effective, Recommends Approval - Kaiser Network Daily Policy Reports (includes links to additional media coverage and addresses issues related to the vaccine)
  
  
• Previous Posts:
  
  • Women's Health News: HPV Vaccine Moves Closer to Approval
    
  • Women's Health News: Status of HPV Vaccine and Cervical Cancer Prevention
  
  

Technorati Tags: cervical cancer; FDA; Gardasil; HPV; Merck; vaccine
MeSH Tags: Papillomavirus, Human; United States Food and Drug Administration; Uterine Cervical Neoplasms/prevention and control; Vaccines