FDA approves 9-valent HPV vaccine The Food and Drug Administration (FDA) has approved a new vaccine that can prevent diseases caused by nine types of human papillomavirus (HPV). Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) covers five more HPV types than predecessor Gardasil, both manufactured by Merck Sharp & Dohme Corp., subsidiary of Merck & Co. Gardasil 9 — approved for females ages 9 through 26 and males ages 9 through 15 — can prevent cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 or 11. It adds protection against five additional HPV types — 31, 33, 45, 52 and 58 — which cause about 20% of cervical cancers and are not covered by previously FDA-approved HPV vaccines. The bivalent HPV vaccine Cervarix (GlaxoSmithKline) protects against HPV types 16 and 18. Gardasil 9 is administered as three separate injections. After the initial injection, the second and third dose follow two and six months later. The safety of Gardasil 9 was evaluated in 13,000 males and females, with the most common adverse reactions being injection site pain, swelling, redness and headache, according to the FDA. A randomized, controlled clinical study was conducted in the United States and internationally in about 14,000 females ages 16 through 26 who tested negative for vaccine HPV types at the start of the study. Participants received either Gardasil or Gardasil 9. Gardasil 9 was found to be 97% effective in preventing cervical, vulvar and vaginal cancers caused by the five additional HPV types (31, 33, 45, 52 and 58). In addition, Gardasil 9 was found to be as effective as Gardasil for the prevention of diseases caused by the four shared HPV types (6, 11, 16 and 18) based on similar antibody responses in participants in clinical studies. Recommendations for use of the vaccine will be considered at the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices meeting Feb. 25-26. AAP policy consideration generally follows. Meanwhile, the quadrivalent and bivalent vaccines will remain on the market and should continue to be used, according to the AAP Committee on Infectious Diseases. Both vaccines protect against types 16 and 18, which cause 70% of cervical and oropharyngeal cancers. For practice tools and resources, visit cdc.gov/vaccines/youarethekey.
Posted on: Mon, 15 Dec 2014 16:34:00 +0000
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