Positive results for Gardasil trial in males
News came from Merck last week that results from its clinical trial of Gardasil in males showed the vaccine's efficacy in preventing HPV-related genital warts and other lesions. No serious safety concerns were found. Here's coverage from the Associated Press and the Merck press release detailing the (as yet unpublished) results which were presented at this European conference last week.
The trial included nearly 4,000 males between the ages of 16 and 26. The vaccine was 90% effective at preventing external genital lesions, the most common of which are genital warts.
Dr. Bernadine Healy, in the news earlier this year for comments seen as supporting a possible link between vaccines and autism, was pleased by these research results about Gardasil, writing about the many benefits of vaccinating males against HPV.
These findings will be part of Merck's eventual application to the FDA to license the vaccine for use in males in addition to females, a decision that has been widely expected for some time.
More interesting, however, will be the decision faced by the Advisory Committee on Immunization Practices regarding its recommendation for Gardasil in males. In particular, it remains to be seen if the direct protection provided against genital warts in males will be sufficient to recommend broad use of the vaccine, and/or what role the indirect benefits of male vaccination (i.e., aiding in the prevention of HPV-related disease in women) will play in the ACIP's recommendation.
No timetable has been set for these actions, but they are sure to be in the news in 2009.
The trial included nearly 4,000 males between the ages of 16 and 26. The vaccine was 90% effective at preventing external genital lesions, the most common of which are genital warts.
Dr. Bernadine Healy, in the news earlier this year for comments seen as supporting a possible link between vaccines and autism, was pleased by these research results about Gardasil, writing about the many benefits of vaccinating males against HPV.
These findings will be part of Merck's eventual application to the FDA to license the vaccine for use in males in addition to females, a decision that has been widely expected for some time.
More interesting, however, will be the decision faced by the Advisory Committee on Immunization Practices regarding its recommendation for Gardasil in males. In particular, it remains to be seen if the direct protection provided against genital warts in males will be sufficient to recommend broad use of the vaccine, and/or what role the indirect benefits of male vaccination (i.e., aiding in the prevention of HPV-related disease in women) will play in the ACIP's recommendation.
No timetable has been set for these actions, but they are sure to be in the news in 2009.
posted by J. Schwartz at 6:07 PM
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