2009年12月14日月曜日

HPVワクチン発売

GSKよりHPVワクチンが発売される。
 GSK日本法人は、日本初の子宮頸がんの予防ワクチン「サーバリックス」
を発売すると発表した。発症原因となるHPVの感染を予防する効果があり、
すでに世界100カ国で承認されている。

ワクチンは、10才~15才でか、性交渉がない場合に効果があるようだ。
米国の一部では、移民に対して強制する地域もあるとのこと。
子宮頸がんが死亡原因の上位となる中での予防措置らしい。
GSKは、加で副作用発症率の高い新型インフルワクチンを製作し、原因を
解明していない。新型インフルと同工程でHPVワクチンを製造すれば、
同確率で、発症率の高いワクチンが製造され、接種することになる。
豪では、政府がHPVワクチンのキャンペーンを実行するようだ。
日本では、新型インフルのワクチン禍補償が決まったが、HPVワクチン禍の
補償は決まっていない。英国の少女のような死亡例を報道せず、葬るのだ
ろうか。より多くの人のための「気高い犠牲者」とするのだろうか。
問題は解決されていないのに、ワクチン接種を推進するのだろか。


Cervical cancer screening update KXAN.com


---【GSK】国内初の子宮頸癌予防ワクチン「サーバリックス」を22日発売‐年1製品投入でワクチン事業に本腰---
2009年12月11日 (金)
http://www.yakuji.co.jp/entry17512.html

 グラクソ・スミスクライン(GSK)は、22日から国内初の子宮頸癌ワクチン「サーバリックス」を発売し、日本でワクチン事業をスタートさせる。適正使用の観点から、予防ワクチンを十分に理解した医療機関のみに納入する予定で、産婦人科・内科・小児科向けのMR1200人を投入し、情報提供を進める方針だ。9日に都内で記者会見した代表取締役専務の平手晴彦氏は、「1年に1製品は新しいワクチンを投入したい」と表明。「サーバリックスの発売によって、遅れていた日本の予防医療の窓を開けたい」と意気込みを語った。
 サーバリックスは、子宮頸癌の約6割に関連するヒトパピローマウイルス(HPV)の16型・18型に似せた粒子を、抗原として含めた2価ワクチン。10歳以上の女性に対し、1回0・5mLを半年間に3回接種することで、子宮頸癌の予防効果が期待できる。
 既に世界101カ国で承認され、1100万回以上の接種実績があるが、国内では自由診療扱い。1本1万2000円、3回の接種で3万6000円の全額自己負担となるが、平手氏は「抗体価は約20年持続するため、年換算すると少ない負担で、子宮頸癌を予防できることを考えれば、十分に価値のあるワクチン」と意義を強調。「子宮頸癌がワクチンで予防できる時代に入ったことを喜びたい」と語った。
 GSKでは、サーバリックスが国内初の予防ワクチンとなることから、適正使用の徹底と正確な情報提供に取り組む方針だ。平手氏は「日本ではワクチンに対する理解が遅れているため、正しく使っていただくことが大事。メーカーとしても、正確な情報を提供していかなければならない」と述べ、産婦人科・内科・小児科の医師向けにMR1200人を投入し、適正使用を進めていく考えを示した。また、子宮頸癌、予防ワクチンの医療情報サイトやメールマガジンなど、医療従事者向けに情報提供を行うと共に、一般向けウェブサイトの開設、啓発冊子の発行などを通じて、市民への啓発活動を積極的に展開する。
 平手氏は、「日本の予防医療に忸怩たる思いを持ち続けてきたが、ようやく予防ワクチンを、日本で初めて発売できる時代になった」と心境を述べた上で、「サーバリックスの発売によって、遅れていた日本の予防医療の窓を開け、エポックメイキングとなった出来事と言われるようにしたい」と、予防医療の変革に向けた意気込みを語った。今後、GSKでは、1年に1製品のワクチン投入を目指し、ワクチン事業を本格的にスタートさせる考えだ。


---子宮頸がん予防ワクチンを22日に発売へ 英製薬大手GSK---
2009.12.10 21:01
http://sankei.jp.msn.com/life/body/091210/bdy0912102103003-n1.htm

 英製薬大手のグラクソ・スミスクライン(GSK)の日本法人は10日、日本初の子宮頸(けい)がんの予防ワクチン「サーバリックス」を22日に発売すると発表した。発症原因となるヒト・パピローマウイルス(HPV)の感染を予防する効果があり、すでに世界100カ国で承認されている。同社は日本でも普及を図り、予防に貢献したい考えだ。
 同ワクチンはHPVの粒子に似せて作った粒子を半年間に計3回接種し、体内の免疫機能を高めてHPVを排除する。メーカー希望納入価格は1回量で1万2000円(税抜き)。自由診療扱いのため、費用は全額自己負担となる。
 GSKのマーク・デュノワイエ社長は「ワクチン接種と定期的な検診で子宮頸がんは100%予防が可能といわれている。多くの女性が接種できるよう努力していく」と意気込みをみせる。
 同社が日本でワクチンを販売するのは初めて。子宮頸がん以外でも、幼児の胃腸炎を起こすロタウイルスの感染予防ワクチンや、新型インフルエンザ用ワクチンの承認を申請済みで、日本でのワクチン事業の強化を目指している。

 日本は過去の予防接種の副作用被害などから、ワクチンへの警戒感が強く、欧米に比べ普及が遅れてきた。GSKによると、世界のワクチン市場が年率10%以上伸びて平成19年には1兆8000億円に達したのに対し、日本は700億円規模にとどまった。
 だが、新型インフル対策などでワクチンの有効性が見直され、今後の需要拡大が期待できるため、国内外の製薬大手が日本のワクチン市場を開拓する動きを加速している。
 製薬最大手の米ファイザー日本法人は今月、日本のワクチン市場に22年にも参入すると表明。国内勢も、塩野義製薬がぼうこうがんのワクチンの臨床試験(治験)を始めたほか、第一三共はワクチン事業の専門部署を新設した。
 各社が開発競争でしのぎを削れば、市場の活性化に加え、予防医療の向上にもつながりそうだ。


---Cervical cancer is preventable---
Published: December 12, 2009 01:41 am
By Judy Rupp, Commentary
http://www.enidnews.com/features/local_story_343191205.html?keyword=topstory

The history of cervical cancer treatment is a 66-year success story marked by two major advances. The first came in 1943 when Dr. George Papanicolaou introduced what has become known as the Pap test, now used worldwide as a screening test to detect cervical changes indicative of cancer. Before that time carcinoma of the cervix was one of the leading causes of death among American women.

The other major advance came in 1975 when German scientist Harald zur Hausen isolated two strains of a virus, human papillomavirus (HPV), found in most cervical cancer biopsies worldwide. This discovery earned Dr. zur Hausen the Nobel Prize for Medicine and set the stage for the successful development of an HPV vaccine.

Currently recommended for females age 11 to 12, the vaccine can be given to girls as young as age 9 and women up to age 26. Such a recommendation is controversial among some groups, but the goal is to immunize females against HPV before they begin sexual activity. If the recommendation is embraced as the Pap test was several decades ago, it could go a long way toward eradicating a cancer that kills 37,000 American women and 274,000 women worldwide every year.

Worries among some that the vaccine might promote sexual activity are ill-founded since the vaccine does not protect against pregnancy nor any other sexually transmitted disease. HPV is an extremely common STD that plays no favorites and is not a result of poor hygiene nor any particular behavior or lifestyle. About 80 percent of persons who ever have sex will be infected with HPV at some time in life, usually without knowing it.

HPV can be transmitted (although rarely) even with use of condoms and even with genital or anal contact that does not include vaginal penetration. Some types cause genital warts, but those most likely to result in cervical cancer typically have no symptoms.

The connection between sex and cervical cancer has long been apparent.

At highest risk of cervical cancer are women who start having sex early in life, have numerous sex partners and have sex with persons who have had numerous sex partners.

Even though young sexually active females are highly likely to become infected with HPV, the vast majority of these infections are short-lived and resolve on their own. A lingering infection with one of the high-risk types of HPV, however, can cause changes in the lining of the cervix that can lead to cancer. This typically occurs over a 10- to 15-year period, however, and that is why the Pap test has become such an important preventive screening tool.

Screening with the Pap test is recommended starting three years after the initiation of sexual activity or age 21, whichever comes first. Up to age 30, a yearly pelvic examination and Pap test can reveal any abnormalities that require attention.

After age 30, women who have had three or more consecutive normal results may have Pap tests every two or three years rather than annually.

The Pap test remains an important preventive tool, and 80 to 90 percent of cervical cancers are diagnosed in women age 35 and over.

At highest risk are women age 35 and over with a lingering infection with one of the high-risk types of human papillomavirus.

In addition to age, risks include smoking, a weakened immune system (particularly as a result of HIV) and hormonal changes related to giving birth at an early age, having many births and using hormonal contraceptives.

In developing countries and in some areas of the United States, cervical cancer deaths remain high because women do not have regular Pap tests - often because they cannot afford it or do not have access to health care.

Effective prevention of cervical cancer in all parts of the world, requires:

Young women know the risk factors for this potentially fatal cancer and become immunized against HPV before they begin sexual activity.

All women know the value of Pap tests and have regular screening tests.

Early studies showed the Gardasil vaccine to be nearly 100 percent effective in preventing infection over a four-year period. Studies are continuing to determine how long this protection can be expected to last.

According to one analysis, if the vaccine were administered to all adolescent females before they start sexual activity, it would within four or five decades, reduce the incidence of cervical cancer by more than 51 percent.

Coupled with the effect of the Pap test, this could be a significant step toward eliminating a potentially fatal cancer.


---GSK says still no answer on whether H1N1 vaccine batch triggers more reaction
By Helen Branswell Medical Reporter (CP) - Nov 24, 2009
http://www.google.com/hostednews/canadianpress/article/ALeqM5hyRQAwdPH-BPk6vy5naAkGl6ZUgw
TORONTO - The investigation into whether a batch of H1N1 vaccine may have triggered a higher-than-normal rate of allergic reactions hasn't yet come up with answers, vaccine manufacturer GlaxoSmithKline said Tuesday.

And health officials in Quebec said they are still trying to determine if the death of an elderly man who died of anaphylaxis after receiving a pandemic flu shot was triggered or hastened by the vaccination.

"Investigations being undertaken by GSK, Health Canada and the Public Health Agency of Canada (PHAC) have not yet been completed," GSK spokesperson Megan Spoore said in an email about the pulled batch of vaccine.

The lot, No. A80CA007A, comprised 172,000 doses of vaccine that were shipped last month to British Columbia, Alberta, Saskatchewan, Manitoba, Ontario and Prince Edward Island.

Quebec did not receive vaccine from the batch under investigation.

After discussions with Health Canada, which regulates vaccines, GSK told provinces last week not to use any more doses from this lot after it came to light that six cases of anaphylaxis had been reported in people who had H1N1 shots from the batch.

The event is raising a lot of questions. Here are some answers:

Q: What is anaphylaxis?

A: Anaphylaxis is a severe allergic reaction that in extreme cases can lead to death. Marked by sudden onset, the reaction can produce hives, cardiovascular problems and swelling of the tissues in the mouth and airways that can compromise breathing.

True anaphylaxis has to meet an internationally accepted diagnostic criterion called the Brighton collaboration case definition. It must involve at least two organ symptoms - in other words, some combination of reactions involving the skin, heart and respiratory systems.

Q: What causes anaphylaxis?

A: Anaphylaxis is an allergic response to exposure to an allergen, a non-pathogenic (i.e. not a germ or a fungus) substance that's capable of triggering a response from the immune system. For some people, pollen is an allergen. For others, peanut protein is.

Why some people are allergic to some things and others are not isn't clear. But when a person with an allergy encounters the specific allergen, his or her immune system generates a type of antibodies that trigger the release of histamines into their system, says Dr. Scott Halperin, a vaccine expert at Dalhousie University. Histamines induce the response.

Q: How is anaphylaxis treated?

A: True anaphylaxis is treated with epinephrine (adrenaline). That's the stuff in EpiPens carried by people with life-threatening allergies.

Q: Are there any doses of this suspect batch of vaccine left?

A: By the time GSK issued the halt-use order last week, all but about 20,000 doses of the batch had been used, a spokesperson for the Public Health Agency of Canada says.

Q: So that's about six cases of anaphylaxis out of about 152,000 shots given. Is that unduly high?

A: GSK said in a statement Tuesday that the expected rate of anaphylactic reactions to flu shots is in about one in 100,000.

Q: Is anaphylaxis a reaction seen with other vaccines or just flu shots.

A: "Any time you immunize somebody with something, there's always a chance of an allergic reaction," says Dr. John Treanor, an influenza vaccine expert at the University of Rochester in New York.

And if you vaccinate millions? "Some people are going to have anaphylaxis, absolutely," Treanor says.

Halperin says the rate of anaphylactic reactions will vary depending on the type of vaccine used and the age of the people the vaccine is being given to.

It can even vary by location. Australia saw higher than expected rates of anaphylaxis when it rolled out its HPV vaccine campaign - about 2.6 cases per 100,000 shots, according to one study. But those elevated rates weren't seen in North America.

Q: Why do some people have allergic reactions to vaccines?

A: "For most times people have anaphylaxis, you don't know exactly what it is. And vaccine is a complex mixture," Halperin says.

Most flu vaccine - and all the flu vaccine used in Canada - is produced in eggs. If there was residual egg protein in the vaccine it could trigger an allergic response in people with egg allergies, he says.

With the combined measles, mumps and rubella vaccine, reactions have occurred that are believed to be due to an antibiotic that is used in the production process, Halperin says.

Q: Why would one batch of vaccine produce more reactions than others?

A: Treanor says that's a difficult question to answer.

"It's hard for me to think of what the mechanism would be for a lot-specific increase in anaphylactic reactions," he says.

"The only thing that would make sense if it was really true that you were seeing with a specific batch that there were more anaphylactic reactions that there's something in that batch that's not in the other batches . . . that people tend to be allergic to."


---Will New Pap Test Guidelines Result in Delayed Administration of Gardasil?
November 20, 2009 04:30 PM
by James Sullivan
http://www.findingdulcinea.com/news/health/2009/november/Will-New-Pap-Test-Guidelines-Result-in-Delayed-Administration-of-Gardasil-.html

New screening guidelines for cervical cancer say girls can wait until age 21 to begin Pap tests, though it is unclear how these recommendations will impact current HPV vaccination guidelines.
Pap Test Guidelines and Gardasil
The guidelines released by the American College of Obstetricians and Gynecologists (ACOG) encourage a shift toward less cervical cancer screening among women. In addition to delaying a woman’s first Pap test to the age of 21, the new guidelines recommend less frequent testing thereafter-once every two years until age 30.

The changes were made due to the rarity of contracting cervical cancer before the age of 21, and to avoid over-treatment and complications from the test. According to the ACOG, “Moving the baseline cervical screening to age 21 is a conservative approach to avoid unnecessary treatment of adolescents which can have economic, emotional, and future childbearing implications. … Although the rate of HPV infection is high among sexually active adolescents, invasive cervical cancer is very rare in women under age 21.”

The Pap test guidelines call into question the existing Centers for Disease Control and Prevention (CDC) rules for the administration of Gardasil, an HPV vaccine created by pharmaceutical giant Merck. The CDC added Gardasil to its routine vaccination schedule in 2007, recommending it for 11- or 12-year-old girls. Some physicians have previously opined that, because the effectiveness of Gardasil after five years has not been established, vaccinations should start at a later age. The ACOG’s new age guidelines would seem to strengthen the argument against early administration of Gardasil.

According to the National Cancer Institute, the previous cervical cancer screening guidelines recommended “that women have a Pap test at least once every 3 years, beginning about 3 years after they begin to have sexual intercourse, but no later than age 21. Experts recommend waiting about 3 years after the start of sexual activity to avoid overtreatment for common, temporary abnormal changes. It is safe to wait 3 years, because cervical cancer usually develops slowly. Cervical cancer is extremely rare in women under age 25.”

Related Topic: Mammogram screening guidelines
The relaxed ACOG screening guidelines come just days after the United States Preventative Services Task Force stirred up controversy by recommending that women begin regular breast cancer screening at age 50 instead of age 40, and continue at two-year intervals afterward. The mammogram guidelines also discouraged doctors from teaching self-screening techniques.

NPR reports that the timing of today’s announcement by the ACOG is “pure coincidence,” and is the result of years of research and evolving scientific evidence.
Background: To Gardasil or not to Gardasil?
In the wake of an August study published in the Journal of the American Medical Association (JAMA) that vouches for the relative safety of Gardasil, a human papillomavirus vaccine, health experts continued to debate the benefits of a generalized application of the vaccine, Denise Mann writes for CNN.

Merck, the manufacturer, proclaims that “only a doctor or health care professional can decide if GARDASIL is right for you or your daughter,” but the lead researcher for the study urges parents to become active participants in the decision.

The JAMA study notes that through the end of 2008, adverse side effects were reported in 12,424 cases, or 53.9 cases per 100,000 doses distributed. This is comparable to other vaccines. The study also notes that 772 of the adverse effects reported are considered serious, including 32 deaths. Cases of fainting and blood clots, in particular, are unusually high for a vaccine. Adverse event reporting is inherently imperfect, because on the one hand, an adverse event after a vaccination does not prove that the vaccine caused the outcome, and on the other hand, many adverse events never get reported.

Lead researcher Dr. Barbara Slade, a medical officer at the CDC, says that the risks posed by Gardasil should “open the dialogue that people need to have with their physician about whether they need to get the vaccine.”

In the same issue of JAMA, Dr. Charlotte Haug of Norway publishes an editorial titled “The Risks and Benefits of HPV Vaccination.” She writes that, in her opinion, “almost all HPV infections are cleared by the immune system … some women may develop precancerous cervical lesions and eventually cervical cancer. It is currently impossible to predict in which women this will occur and why. Likewise, it is impossible to predict exactly what effect vaccination of young girls and women will have on the incidence of cervical cancer 20 to 40 years from now.”

The CDC regularly reviews adverse event reports and updates its guidance on vaccines. Based on its review of adverse events related to Gardasil through Sept. 1, 2009, the CDC saw no medical patterns that suggest that Gardasil caused the adverse events reported, and it continues to recommend the vaccine.


---CDC will no longer require HPV vaccine for immigrant girls and women---
By Anabelle Garay, AP
November 16th, 2009
http://blog.taragana.com/health/2009/11/16/cdc-will-no-longer-require-hpv-vaccine-for-immigrant-girls-and-women-15712/

Green card seekers won’t have to get HPV vaccine

DALLAS - Immigrant girls and women will no longer have to be vaccinated against a sexually transmitted virus to get their green cards.

Starting Dec. 14, the HPV, or human papillomavirus vaccine will no longer be on the list of immunizations female immigrants ages 11 to 26 must receive before becoming legal permanent residents.

The U.S. Centers for Disease Control and Prevention made the change on Friday. The CDC said it will require immunizations for which there is a public health need either at the time the person immigrates or changes their status to green card holder.

“More than half of the immigrants who come to the U.S. seeking opportunity are women,” Silvia Henriquez, executive director of the National Latina Institute for Reproductive Health, said in a statement. “We thank the CDC for restoring their dignity and reproductive justice.”

Girls and women seeking to become legal permanent U.S. residents were required to get at least the first dose of the HPV vaccine, which protects against some strains of the virus blamed for cervical cancer. It was added to the list of required vaccinations for immigrants in July 2008.

Soon after, a coalition of more than 100 immigrant, health and women’s advocacy groups challenged the requirement, saying it was unfair to require the HPV vaccine for immigrants but not for most U.S. citizens.

Attempts to require the vaccine for American girls has brought emotional debate and complaints that such mandates intrude on family decisions about sex education. In Texas, lawmakers fought off a 2007 order by Gov. Rick Perry requiring the shots for sixth-grade girls amid questions about vaccine’s safety, efficacy and cost.

At a price of $400 to $1,000 for the three-shot series, the vaccine also was an added burden on green card applicants already paying more than a thousand dollars in application fees and hundreds of dollars for mandatory medical exams. Insurance companies do not cover health services required for immigration purposes, advocates pointed out.

“It also put the financial burden on the individual woman and her family,” Gabriela Valle, senior director of community outreach and mobilization for California Latinas for Reproductive Justice, said Monday. “Not only are you taking my rights to make an informed decision over my body, over myself, over my daughter, but you’re having me pay for it as well.”

The U.S. Food and Drug Administration approved Merck & Co.’s Gardasil in 2006 to protect against the human papillomavirus. The CDC immunization advisory committee quickly followed up by recommending it for girls and young women.

For U.S. citizens, the committee’s recommendations serve only to provide guidance on vaccines. But a 1996 change to the nation’s immigration laws required anyone seeking permanent residency to get all the vaccinations recommended by the committee.

The CDC’s newly adopted criteria to determine which vaccines will be required for immigrants says the vaccine must be age appropriate. It also must protect against a disease that has the potential to cause an outbreak, has been eliminated in the U.S. or is in the process of being eliminated from the country.

Aside from removing the HPV vaccine mandate, the change also means the Zoster vaccine to protect against shingles won’t be required of immigrants 60 or older.

“They are not easily transmissible,” Dr. Katrin Kohl, deputy director in the CDC’s division of global migration and quarantine, said of the two. “They don’t fit into the whole public health spirit of outbreak prevention.”

However, the agency continues to recommend both vaccines, Kohl said.

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