NEW YORK -- October 16, 2009 -- The US Food and Drug Administration (FDA) has approved the human papillomavirus (HPV) quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant (Gardasil) for use in boys and men aged 9 to 26 years for the prevention of genital warts caused by HPV types 6 and 11.
It is estimated that HPV types 16 and 18 account for 70% of cervical and vaginal cancer cases and up to 50% of vulvar cancer cases. Types 6 and 11 cause approximately 90% of all genital warts cases.
In phase 3 studies over a period of 3 years of more than 4,000 males aged 16 to 26 years, the HPV vaccine was efficacious in reducing the incidence of genital warts related to HPV types 6 and 11 in males who were naïve to the relevant HPV type(s) 6, 11, 16, and 18.
The HPV vaccine was 90.4% efficacious against HPV 6, 11, 16, and 18-related external genital lesions (EGL) There were 3 cases in the vaccine group (n = 1,397) vs 31 cases in the placebo group (n = 1,408). Of the 34 cases of EGL, 31 were genital warts.
The vaccine was 89% efficacious against HPV 6- and 11-related genital warts. There were 3 cases in the vaccine group and 28 cases in the placebo group). There were 3 cases of HPV 6, 11, 16, or 18-related penile/perianal/perineal intraepithelial neoplasia (PIN) and all were in the placebo group. Vaccine efficacy against HPV 6, 11, 16, and 18-related PIN 1 or worse was not demonstrated, as the number of cases was too limited to reach statistical significance.
The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of the vaccine at a frequency of at least 1.0% and greater than placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising.
SOURCE: Merck & Co., Inc.
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