HPV vaccine studied for first time in men

Source: www.sciencedaily.com Author: staff A vaccine designed to protect against the most common causes of genital warts and cervical and penile cancer is now being evaluated in young men. The Medical College of Georgia is a site for the first international study of a vaccine that protects against four strains of human papillomavirus in men age 16 to 23. “It’s a great opportunity for men to protect themselves from developing genital warts and penile cancer,” says Dr. Daron G. Ferris, a principal investigator on the study who directs the MCG Gynecologic Cancer Prevention Center. “It’s also a great way for men to protect their sexual partners from developing warts as well as cervical cancer, lower genital tract cancers and precancerous changes of the cervix.” MCG also is studying the vaccine in boys and girls age 10 to 15 and is still enrolling women age 15 to 45 in several other studies. “We are interested in looking at the efficacy of this vaccine in populations that will become target populations, should the Food and Drug Administration approve the vaccine,” Dr. Ferris says. MCG was the largest site in North America for the study in women age 15 to 25 of a vaccine for HPV types 16 and 18, the two most common causes of cervical and penile cancer. That vaccine was reported 100 percent effective at preventing the persistent HPV infections that cause cervical cancer in the Nov. 13 issue of the British journal, The Lancet. This newest study in men [...]

FDA Advisory Committee recommends approval for use of GARDASIL® in boys and men

Source: www.merck.com Author: press release Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL¨ [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11. "Merck has been committed to pursuing the use of GARDASIL in both males and females since the vaccine was discovered over a decade ago," said Peter S. Kim, Ph.D., executive vice president, and president of Merck Research Laboratories.  "We are pleased that the Advisory Committee agrees that the data support the use of GARDASIL in boys and men.” The committee’s recommendation will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) that Merck submitted for GARDASIL in December 2008.  The FDA is not bound by the committee’s guidance, but takes its advice into consideration when reviewing vaccines.  Merck expects a decision from the FDA in the fourth quarter of 2009 after the agency has completed its review of Merck's application. “Today's discussion with the Advisory Committee brings the public health community closer to being able to provide GARDASIL to both men and women," said Anna R. Giuliano, Ph.D., Moffitt Cancer Center. GARDASIL has been approved for use in the U.S. since June 2006 and is [...]

2009-09-09T21:02:25-07:00September, 2009|Oral Cancer News|
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