Boys soon will be able to get Gardasil, the vaccine given to girls and young women to prevent infection by four types of human papillomavirus.
A Food and Drug Administration advisory committee took a decision Wednesday to recommend that the vaccine be made available to boys and young men aged 9 to 26 for protection against genital warts caused by HPV.
The vaccine protects against four types of HPV, and two of those are believed to be responsible for 70 percent of cervical and anal cancers, and HPV-associated penile and throat-and-neck cancers. The other two cause 90 percent of genital warts cases, researchers say.
At Wednesday's advisory committee meeting, pharmaceutical giant Merck & Co., maker of Gardasil, presented data from three clinical trials that the company claims supports broadening the distribution of the vaccine to include males. The trials included more than 5,400 boys and men from six continents and 23 countries.
According to Anna Giuliano, an independent scientist at Moffit Cancer Center in Tampa, Florida, and the trials' principal investigator, "The data clearly demonstrates that there was a benefit to men in receiving Gardasil. Overall, we saw a 90 percent reduction in disease -- genital warts and pre-cancerous lesions -- caused by HPV in men and an 89 percent reduction in genital warts incidence, CNN reports.
It was also reported, specifically, the panel of outside medical experts voted 7 to 0 in favor of a question that asked if the data submitted by Merck showed whether Gardasil was effective at preventing genital warts in males 9 to 26 years of age. One person abstained from voting. On safety, the panel voted 7 to 1 in favor of question that asked if the data showed whether the vaccine was safe.
While the votes amount to a recommendation that the agency approve the vaccine, many panel members said they were concerned about the lack of long-term data that would show how long the vaccine offers protection against HPV infection, CNN reports.
In the meantime, the FDA’s panel of vaccine experts voted overwhelmingly Wednesday that Cervarix appears safe and effective for girls and women age 10 to 25. If the FDA follows the group’s advice as it usually does, Glaxo would begin competing against Merck’s Gardasil, which has controlled the U.S. market since 2006.
But Merck won its own small victory at the meeting, as the same panel recommended Gardasil be expanded to prevent genital warts in boys, a new use for a vaccine that already posts sales of more than $1 billion.
Last year nearly 4,000 women died of cervical cancer in the U.S., less than 1 percent of all cancer related deaths, Youngstown Vindicator reports.
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