Impact of GARDASIL in women already infected with HPV types targeted by the vaccine
This study also assessed the efficacy of GARDASIL in a broader population, including those who had HPV 6-, 11-, 16- or 18-related infection or disease at study initiation. In this group, GARDASIL reduced the incidence of HPV 16- or 18- related VIN 2/3 or VaIN 2/3 by 71 percent; nine cases were observed in the vaccine group (n= 9,087); 31 cases were observed in the placebo group (n=9,087). In eight of the nine vaccine cases and two of the placebo cases, individuals were infected with HPV 16 or 18 prior to receiving the first dose. There were also five cases of VIN 2/3 or VaIN 2/3 in the placebo group that were associated with HPV type 6 and not associated with type 16 or 18. None were associated with HPV type 11.
In all three studies used in the analysis, the adverse events observed were similar to what has been previously reported. The most common treatment-related adverse event was injection-site pain.
Additional important information about GARDASIL
The health-care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.
Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to other HPV types.
In clinical studies for GARDASIL, vaccine-related adverse
experiences that were observed at a frequency of at least 1.0
percent among recipients of GARDASIL and also greater than those
observed among recipients of placebo, respectively, were pain (83.9
percent vs. 75.4 percent), swelling