FDA Approves Gardasil 9 Vaccine

The Food and Drug Administration (FDA) has approved Gardasil 9 (9-valent human papillomavirus types, recombinant; Merck) vaccine for the prevention of cervical, vulvar, vaginal, anal cancers, and for the prevention of genital warts caused by nine types of human papillomavirus (HPV). It is indicated for use in females 9–26 years old and males 9–15 years old.

Gardasil 9 covers five more types of HPV than the currently approved Gardasil (quadrivalent human papillomavirus types, recombinant) vaccine: HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58.

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A clinical study evaluated 14,000 females ages 16–26 who were negative for vaccine HPV types at study initiation. Patients were randomized to Gardasil or Gardasil 9. Results showed Gardasil 9 was 97% effective in the prevention of cervical, vulvar, and vaginal cancers caused by the five additional HPV types (31, 33, 43, 52, and 58). Also, similar antibody responses in both groups were seen in the prevention of diseases caused by the four HPV types (6, 11, 16, 18) shared in common.

The efficacy of Gardasil 9 in females and males aged 9–15 years was established in studies that measured antibody responses to the vaccine (approximately 4,000 participants). Their antibody responses were similar to those in females ages 16–26. From these results, Gardasil 9 is predicted to have similar efficacy when administered in the younger age group.

For more information call (800) 672-6372 or visit Merck.com.