Paper
FDA approves Gardasil 9 for more types of HPV
Published Apr 15, 2015 · C. Printz
Cancer
41
Citations
1
Influential Citations
Abstract
In December 2014, the FDA approved Gardasil 9 (human papillomavirus [HPV] 9-valent vaccine recombinant) (Merck and Company, Kenilworth, NJ) for the prevention of certain diseases caused by 9 types of HPV. The new vaccine covers 5 more HPV types than the previously approved formulation of Gardasil. The new vaccine is approved for use in females aged 9 to 26 years and males aged 9 to 15 years. It has the potential to prevent approximately 90% of cervical, vulvar, vaginal, and anal cancers. Specifically, it is approved to prevent those cancers that are caused by HPV types 16, 18, 31, 33, 45, 52, and 58 and for the prevention of genital warts caused by HPV types 6 or 11. The 5 additional HPV types covered by Gardasil 9 (types 31, 33, 45, 52, and 58) account for approximately 20% of cervical cancers. A randomized controlled clinical study performed both in the United States and worldwide examined 14,000 females between the ages of 16 and 26 years who tested negative for various HPV types at the start of the study. The participants received either Gardasil or Gardasil 9, and the latter was determined to be 97% effective in the 5 additional HPV types. Furthermore, Gardasil 9 was found to be as effective as Gardasil for the prevention of the 4 shared HPV types covered by both vaccines. The effectiveness of Gardasil 9 in the younger age group (those aged 9-15 years) was determined in studies that measured antibody responses to the vaccine. The responses were similar to those observed in females aged 16 to 26 years. Based on these results, the vaccine is expected to have similar effectiveness in this group of individuals. Similar to Gardasil, Gardasil 9 is administered as 3 separate injections. The benefit is obtained by individuals who have been vaccinated prior to becoming infected with any of the covered HPV strains. The safety of Gardasil 9 was determined in approximately 13,000 males and females, and the most commonly reported side effects were injection site pain, redness, swelling, and headaches.
Gardasil 9 is a new vaccine that effectively prevents 90% of cervical, vulvar, vaginal, and anal cancers, covering 5 more HPV types than Gardasil.
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