FDA panel agrees HPV vaccine safe, effective in boys, men

The FDA’s Vaccines and Related Biological Products Advisory Committee agreed today that Merck’s human papillomavirus vaccine, Gardasil, is effective in staving off genital warts in males.

Merck officials have presented data showing the vaccine prevented 90.4% of external genital lesions related to HPV types 6, 11, 16 and 18 in males and showing the vaccine reduced persistent infection with vaccine HPV types 6, 11, 16 and 18 by 85.6% in males. There was a low rate of adverse events in this study population, according to data presented today.

Committee members unanimously agreed the vaccine was effective in preventing genital warts, but agreed that more data are needed, specifically long-term immunogenicity data and data in certain high-risk populations, including men who have sex with men.

“We need studies that examine the long-term immunogenicity which will in turn provide guidance on whether or not future boosters will be needed,” said Pablo Sanchez, MD, who is a panel member and a professor of pediatrics at the University of Texas Southwestern Medical Center at Dallas.

Committee member Vicky Debold, PhD, RN,said that she felt the committee should hold off on recommending the vaccine until additional safety data are available in girls. She cited a study in last month’s Journal of American Medical Association that suggested a slight increased risk of certain adverse events, including fainting and developing blood clots, that she felt needed more examination before a broad-based recommendation was made for males aged 9 to 26 years.

The committee’s recommendations are forwarded to the FDA, who will then vote on whether or not to recommend the vaccine in this population. – by Colleen Zacharyczuk