FDA approves 9-valent HPV vaccine to prevent certain cancers
the ONA take:
Merck & Co., Inc. has announced that the U.S. Food and Drug Administration has approved Gardasil 9, a 9-valent human papillomavirus (HPV) recombinant vaccine for the prevention of anal, cervical, vaginal, and vulvar cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. It is also approved for the prevention of gential warts caused by HPV types 6 and 11.
The FDA approved Gardasil 9 for use in females aged 9 to 26 years and males aged 9 to 15 years. The original Gardasil vaccine only protects against types 6, 11, 16, and 18, while the new vaccine helps to protect against five additional strains.
The approval is based on a controlled trial involving about 14,000 females aged 16 to 26 years who were negative for any HPV subtypes covered by Gardasil or Gardasil 9. Patients were randomly assigned to receive Gardasil or Gardasil 9.
Results showed that Gardasil 9 was 97% more effective than Gardasil at preventing cervical, vaginal, and vulvar cancer caused by HPV types 31, 33, 45, 52, and 58, and was as effective as Gardasil at preventing diseases caused by HPV types 6, 11, 16, and 18.
Like Gardasil, Gardasil 9 is administered to patients as three separate injections, with the second administered 2 months after the first, and the third administered 4 months after that.
The FDA has approved Gardasil 9 for the prevention of anal, cervical, vaginal, and vulvar cancers.
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