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FDA Approves Merck's Updated HPV Vaccine

FDA Approves Merck's Updated HPV Vaccine

December 11, 2014 — FDA on Wednesday approved an updated version of Merck's human papillomavirus vaccine, which protects against five additional strains of the virus that are strongly linked to cancer, the Wall Street Journal reports.

According to the Journal, the new vaccine, Gardasil 9, protects against HPV strains that together account for about 90% of cervical cancer cases. The original vaccine, Gardasil, protects against four HPV strains, including two types linked to roughly 70% of all cervical cancer cases.

Approval Details

FDA approved Gardasil 9 for boys age nine through 15 and for girls and women age nine through 26 to protect against the anal, cervical, vaginal and vulvar cancers caused by seven HPV strains (Loftus, Wall Street Journal, 12/10). The vaccine is also approved to protect against genital warts caused by two strains of the virus (AP/U-T San Diego, 12/10).

The updated vaccine will be administered in a series of three shots over six months, which is the same schedule as the original vaccine, the Journal reports (Wall Street Journal, 12/10).

According to HealthDay/U.S. News & World Report, FDA based its approval on a clinical trial involving about 14,000 women and girls ages 16 to 26 who did not have HPV at the onset of the study and who were vaccinated with either Gardasil or Gardasil 9. Specifically, FDA said the study demonstrated that Gardasil 9 was found "to be 97 percent effective in preventing cervical, vulvar and vaginal cancers caused by the five additional HPV" strains and as effective as Gardasil in preventing diseases caused by the four HPV strains covered by both vaccines (Mundell, HealthDay/U.S. News & World Report, 12/10).

Merck anticipates that providers will shift from Gardasil to Gardasil 9 if CDC's vaccine advisory committee recommends doing so. According to the Journal, the updated vaccine will cost roughly $162 for a single dose in the U.S. when purchased in a pack of 10 doses, compared with the original vaccine's cost of about $146 per dose (Wall Street Journal, 12/10).