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FDA Approves Gardasil Vaccine for Cervical Cancer and Genital Warts Prevention

Strategic Insights

— 2 min read

Merck & Co., Inc. announced the U.S. Food and Drug Administration's (FDA) approval of Gardasil, a vaccine designed to prevent cervical cancer and genital warts caused by human papillomavirus (HPV) types 6, 11, 16, and 18. The approval marks a significant breakthrough in the prevention of cervical cancer, with approximately 10,000 women diagnosed with the disease annually in the United States. Gardasil is also approved for the prevention of low-grade and pre-cancerous lesions and genital warts caused by HPV types 6, 11, 16, and 18.

Key Takeaways:

  • Gardasil is the first vaccine to prevent cervical cancer and genital warts caused by HPV types 6, 11, 16, and 18.
  • The vaccine is approved for use in 9- to 26-year-old girls and women.
  • Gardasil is designed to prevent the majority of HPV-related clinical diseases, including 70% of cervical cancer cases caused by HPV types 16 and 18.
  • In clinical studies, Gardasil showed 100% efficacy in preventing HPV 16- and 18-related cervical cancer in women not previously exposed to the relevant HPV types.
  • The vaccine has been shown to be generally well-tolerated, with few subjects (0.1%) discontinuing due to adverse events.
  • Prior vaccination strategies have demonstrated that adolescents are an important group to vaccinate against HPV, with one in four people ages 15 to 24 infected with the virus.
  • Merck studied the anti-HPV 6, -11, -16, and -18 immune responses for Gardasil in 10- to 15-year-old girls compared to those in 16- to 23-year-old adolescent and young adult women and found similar outcomes.

Statistics:

  • In the United States, approximately 10,000 women are diagnosed with cervical cancer every year.
  • An average of 10 women die each day from cervical cancer in the United States.
  • HPV types 16 and 18 account for approximately 70% of cases of cervical cancer, AIS (non-invasive cervical cancer), CIN 3, VIN 2/3, and VaIN 2/3.
  • HPV 6 and 11 cause approximately 90% of genital wart cases.
  • Estimated 4.7 million abnormal Pap results require follow-up each year in the United States.
  • At least 3 million of these results are caused by some type of HPV.
  • Among the study participants who received Gardasil, the immune responses (geometric mean titers, GMTs) in 10- to 15-year-old girls were similar to those in 16- to 23-year-old women.
  • Gardasil reduced the risk for development of cervical pre-cancerous lesions and cervical cancer caused by HPV types 16 and 18 by approximately 40% in just 2 to 4 years.

Sources:

  • Merck & Co., Inc.
  • U.S. Food and Drug Administration (FDA)
  • Health & Medicine Week
  • NewsRx.com

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