FDA Panel Says Yes to Gardasil for Boys
A Food & Drug Administration (FDA) advisory panel has recommended that Gardasil be approved for boys and young men aged 9 to 26 for protection against genital warts caused by HPV.
According to CNN, at yesterday’s advisory panel meeting, Merck presented data from three clinical trials that the company claims supports broadening the distribution of the vaccine to include males. According to Merck, the trials saw a 90 percent reduction in genital warts and pre-cancerous lesions caused by HPV in men, and an 89 percent reduction in genital warts incidence. Merck also claimed that no serious adverse events related to the vaccine were reported , and that side effects – such as fever and pain at the injection site – were mild.
According to the Associated Press, the advisory panel voted unanimously with one abstention that the vaccine is effective for preventing HPV, in males ages 9 to 26. The panel voted 7-1 that the vaccine is safe for those patients.
The FDA is not required to follow the recommendations of its advisory panels, but it usually does so.