医師の一分

アクセスカウンタ

zoom RSS 男子にもHPVワクチンを/FDA

<<   作成日時 : 2009/09/14 21:38   >>

ブログ気持玉 0 / トラックバック 0 / コメント 0

画像 FDA諮問機関は子宮頸癌予防ワクチンのGardasilを、男性性器疣贅予防に対して9-26才男性への使用を推薦することを可決した。メルクがFDAに承認申請していたものである。子宮頸癌予防には9才以上の女性への使用がすでに認可されている。
 また、HPVワクチンとしては2番目のグラクソのCervarixが、10-25才女性での使用も可決された。FDAはこのワクチンについてのより多くの研究が必要だとして2007年に導入延期されていたものである。
 HPVワクチンGardasilの副作用については、先月研究が発表された。10万接種に対して失神 8.2、血栓症 0.2であった。
------------------
子宮頚癌予防のHPVワクチンの安全性/米国医療事情 Gardasil
http://kurie.at.webry.info/200908/article_38.html
メルクが男性用にHPVワクチンをFDAに承認申請/米国医療事情
http://kurie.at.webry.info/200901/article_10.html
ZARD坂井泉水死去/子宮頚癌とHPVウイルス(21) 男子にもHPVワクチン
http://kurie.at.webry.info/200802/article_43.html
口腔ガンが急増/米国 口腔・咽頭がん
http://kurie.at.webry.info/200810/article_37.html
HPVによる男性の上咽頭癌の増加
http://kurie.at.webry.info/200802/article_9.html
---------------------------------------------------
FDA Panel Backs Giving HPV Vaccine Gardasil to Young Males
The advisors also recommend approval of second HPV vaccine, Cervarix, to prevent cervical cancer.
By Amanda Gardner HealthDay Reporter Sept. 10
http://abcnews.go.com/Health/Healthday/fda-panel-backs-giving-hpv-vaccine-gardasil-boys/story?id=8531585

WEDNESDAY, Sept. 9 (HealthDay News) -- U.S. drug advisors recommended Wednesday that use of the vaccine Gardasil, already administered to help prevent cervical cancer in women, be expanded to help prevent genital warts in young males.

A U.S. Food and Drug Administration advisory panel voted to recommend the expanded use of the vaccine for males 9 to 26. The FDA is not required to follow its advisory panels' recommendations, but it typically does.

The vaccine targets the human papilloma virus, which can cause genital warts in both males and females, cervical cancer in women and also penile and anal cancer in men -- although these remain much rarer than cervical malignancies.

The vaccine is manufactured by drug maker Merck & Co.

Merck had asked the FDA to approve Gardasil for males ages 9 to 26. It is already approved in females 9 and older to help prevent cervical cancer.

Before the Gardasil vote, the committee on Wednesday also voted that a second HPV vaccine, GlaxoSmithKline's Cervarix, seems safe for girls and women ages 10 to 25 for the prevention of cervical cancer. Studies have shown that the vaccine prevents infection with HPV 93 percent of the time. The introduction of Cervarix was delayed in 2007 when the FDA said it needed more research on the vaccine.

The FDA advisors -- comprising the Vaccines and Related Biological Products Advisory Committee -- said Wednesday that newer studies suggest the Cervarix vaccine is safe, but they recommended follow-up studies to look for miscarriages and muscular problems reported by a small number of patients, the Associated Press reported.

The vote to expand the use of Gardasil to males was not unexpected among health experts.

"It is really hard to get a read on these things, but I don't think anybody is going to be shocked if eventually this is extended to boys, especially since the science is pretty solid here," Fred Wyand, a spokesman for the American Social Health Association, in Research Triangle Park, N.C., said before the vote.

"I would not be surprised at all if FDA approved the new indication," agreed Dr. Jonathan L. Temte, a professor of family medicine at the University of Wisconsin School of Medicine and Public Health in Madison.

Temte is also a voting member of the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) and explained that if the FDA approves the new use for males, the CDC committee can expect to see the item on its agenda in October.

Health experts believe it makes sense to vaccinate boys against the HPV virus.

"We're supportive in general of giving vaccines to boys for a number of reasons," Wyand said. "Clinical trials have shown it's pretty effective -- 90 percent effective in preventing genital lesions [in boys]. Trials in a subset of gay men also found the vaccine to be effective in preventing external lesions, so the signs are pretty clear that it works in guys."

Vaccinating boys would help shield girls, too, the experts added.

"It's a sexually transmitted disease, and it takes two people to transmit the virus," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La. "If the vaccine can reduce the risk of infection in men as well as women, then I believe it should be given to both men and women."

But Gardasil has generated controversy, especially with some conservatives and parents' rights groups who contend the vaccine could promote premarital sex.

Gardasil, which was approved for girls in 2006, covers four types of HPV, two of which cause about 70 percent of cervical cancers worldwide.

Since its approval, Gardasil has proven to be safe and nearly 100 percent effective in preventing precancerous cervical lesions from the four HPV strains targeted by the vaccine, according to studies. However, there have been side effects reported that include fainting and blood clotting. Research published last month found that for every 100,000 doses of HPV vaccine distributed, there were 8.2 episodes of fainting and 0.2 episodes involving blood clotting.

Studies have also found that Gardasil is much more effective when given to girls or young women before they become sexually active.

"The reason you give this is to prevent disease, and that's why we start at 11 or 12, before girls are sexually active," said Dr. Lolita McDavid, medical director of Child Advocacy and Protection at University Hospitals Case Medical Center in Cleveland. "About 10,000 American women will get cervical cancer in a year; about 3,700 are going to die from it."

"About 250,000 new case of genital warts appear in males every year," she added. "There certainly seems to be a benefit for males."

Experts hope that making the vaccine available for boys will have additional, non-medical benefits.

"Countless studies show that a lot of shame and stigma almost universally comes with any HPV diagnosis," Wyand said. "That's another factor that weighs into it. Hopefully, approving the vaccine for males would reduce any stigma."

More information

There's more on HPV at the U.S. Centers for Disease Control and Prevention.

SOURCES: Fred Wyand, spokesman, American Social Health Association, Research Triangle Park, N.C.; Jay Brooks, M.D., chairman, hematology/oncology, Ochsner Health System, Baton Rouge, La.; Lolita McDavid, M.D., medical director, Child Advocacy & Protection, University Hospitals Case Medical Center, Cleveland; Jonathan L. Temte, M.D., Ph.D., professor, family medicine, University of Wisconsin School of Medicine and Public Health, and voting member, Advisory Committee on Immunization Practices, CDC; briefing materials, U.S. Food and Drug Administration; Associated Press

Copyright 2009 HealthDayNews, Inc. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

テーマ

関連テーマ 一覧


月別リンク

ブログ気持玉

クリックして気持ちを伝えよう!
ログインしてクリックすれば、自分のブログへのリンクが付きます。
→ログインへ

トラックバック(0件)

タイトル (本文) ブログ名/日時

トラックバック用URL help


自分のブログにトラックバック記事作成(会員用) help

タイトル
本 文

コメント(0件)

内 容 ニックネーム/日時

コメントする help

ニックネーム
本 文
男子にもHPVワクチンを/FDA 医師の一分/BIGLOBEウェブリブログ
文字サイズ:       閉じる