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zoom RSS 子宮頚がんワクチン接種後14才女子が死亡/英国 HPVワクチン

<<   作成日時 : 2009/09/30 20:58   >>

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画像 英国の学校で子宮頚癌ワクチンCervarix接種後に14才の女子が死亡した。当局は至急原因を徹底調査するとしている。
 英国では140万人が接種を受け、4,657の副反応報告があった。薬品健康規制局MHRAによれば、2008/04/14-2009/09/23 の間に 2,137 の報告があった。命に関わるような重症な反応のリスクは100万回に1回と概算されている。
画像 ナタリー・モートンの死亡は潜在的な健康問題があったか、関係なく偶然起きたものかの可能性がある。
 GlaxoSmithKline製のCervarixワクチンを使って、12-13歳の女子に予防接種するプログラムは英国全土で2008年9月に始まった。さらに年長の女子向けのキャッチアップ・キャンペーンが進行中である。約100万人がすでに接種をうけたという。
 英国では毎年約3,000人が子宮癌と診断され、約1,000人が死亡している。CervarixはHPVの2つの株による子宮頸癌の70%以上の原因を予防する。予防接種は強制的でなく、16才以下では、同意は必要とされている。
 Crvarixは2007年9月に欧州での使用の認可がおりた。
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 ナタリーは全国的な予防接種プログラムの一部として学校で予防接種を受けた。ヒト乳頭腫ウイルス(HPV)(ほとんどの子宮頸癌と関連する性感染症)に対して予防効果がある。キャロングレンジャー博士(NHSコベントリとコベントリ市議会の公衆衛生の合同ディレクター)は、遺体調査の暫定的結果によれば、「死に至る可能性のある重大な潜在的病態が明らかになった」と言う。さらに詳しい検査が必要だが、HPV予防接種が死因である可能性は極めて少ないという。
 ワクチンの保存隔離が行われ、コベントリの予防接種クリニックは一時閉鎖され、ワクチンが製造者であるGlaxoSmithKlineによって調査される。
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子宮けいがんワクチン 承認へ
http://www.nhk.or.jp/news/k10015778751000.html
9月29日 21時4分
 女性のがんで乳がんに次いで多い「子宮けいがん」を予防するワクチンが、29日開かれた厚生労働省の検討会で国内で初めて承認され、年内にもワクチンの販売が始まる見通しになりました。
 子宮けいがんは、子宮の入り口付近にできるがんで、国内では毎年、およそ8000人が診断され、死亡する人は年間およそ2500人に上るとみられています。ウイルスへの感染が主な原因とされ、海外では感染予防のためのワクチンが、すでにおよそ100か国で承認されています。国内では2年前に製薬会社から申請が出され、厚生労働省の薬事分科会が検討を進めてきました。その結果、29日の分科会で「効果や安全性に問題はなく承認して差し支えない」という結論がまとまりました。これを受けて厚生労働省は、10月中にも正式に承認する方針で、年内にはワクチンの販売が始まる見通しになりました。
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子宮頸がん予防ワクチン承認決定、国内初
http://www.yomiuri.co.jp/science/news/20090929-OYT1T00980.htm
 厚生労働省の薬事・食品衛生審議会の薬事分科会は29日、子宮頸(けい)がんを予防するワクチン「サーバリックス」の製造販売を承認することを決めた。
 国内で子宮頸がんワクチンが承認されるのは初めて。
 グラクソ・スミスクライン社が製造販売する。
 子宮頸がんの主な原因であるヒトパピローマウイルス(HPV)のうち、7割を占める2種類のウイルス感染を防ぐことができると期待されている。
 10歳以上の女性が接種対象で、3回の接種が必要。同社は年内にも販売を開始する計画だ。
(2009年9月29日19時27分 読売新聞)
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Page last updated at 08:36 GMT, Tuesday, 29 September 2009 09:36 UK
Cancer jab alert after girl dies
http://news.bbc.co.uk/2/hi/health/8279855.stm

画像Blue Coat CofE School
Other girls at the school reported mild symptoms like dizziness and nausea

Health chiefs have launched a "full and urgent" investigation into the death of a 14-year-old girl after she was given a cervical cancer vaccine at school.

Post-mortem tests into the exact cause are expected to be held on Tuesday.
The girl, named as Natalie Morton, died in hospital on Monday after receiving the Cervarix jab at the Blue Coat CofE School in Coventry.
There have been 4,657 suspected reactions to Cervarix from more than 1.4m doses, according to experts.
The Medicines and Healthcare Regulatory Agency added it had received 2,137 reports between 14 April 2008 and 23 September this year.
However, the risk of severe, potentially life-threatening reactions is estimated at no more than one per million doses of vaccine.
And it is possible that Natalie's death was due to an underlying health problem, or was a coincidence, and nothing directly to do with the vaccine.

Dizziness and nausea
Coventry PCT's Mike Attwood: 'We are pausing the immunisation programme'
The batch of the vaccine used has been placed into quarantine as a "precautionary measure".
The local NHS also confirmed the vaccination programme would continue, but after a "short pause".
Dr Caron Grainger, joint director of public health for NHS Coventry and Coventry City Council, said their sympathies were with the girl's family and friends.

Once in a while you will expect someone to have a severe allergic reaction to a vaccine, just as with food or any medication
Dr David Elliman
Great Ormond Street Hospital

Q&A: The cervical cancer vaccine

She said: "The incident happened shortly after the girl had received her HPV vaccine in the school. No link can be made between the death and the vaccine until all the facts are known and a post-mortem takes place.
"We are conducting an urgent and full investigation into the events surrounding this tragedy."
The teenager died at the city's University Hospital on Monday lunchtime.
A small number of girls at the school had also reported mild symptoms such as dizziness and nausea but were not admitted to hospital.

In a statement posted on the school's website, headteacher Dr Julie Roberts said during the immunisation, "one of the girls suffered a rare, but extreme reaction to the vaccine".
"A number of other girls also reported being unwell and some were sent home," she said.
"If your daughter has received a vaccine today we ask that you are extra vigilant regarding any signs or symptoms."
Julie Roberts
Dr Julie Roberts has urged parents to be extra vigilant for signs of symptoms

She listed possible reactions as mild to moderate short-lasting pain at the injection site, headache, muscle pain, fatigue and a low-grade fever.
The injection - part of a national immunisation programme - protects against the human papilloma virus (HPV), a sexually transmitted disease linked to most cervical cancers.
A routine programme of vaccinating 12 and 13-year-old girls started in September 2008 across the UK using the Cervarix vaccine made by GlaxoSmithKline. A catch-up campaign is now under way for older girls.
It is thought about a million girls have already safely received the jab.
Dr David Elliman, a consultant in community paediatrics at Great Ormond Street Hospital, told the BBC it was important to investigate "very quickly" to allay people's fears about the safety of the jab.
He said: "Once in a while you will expect someone to have a severe allergic reaction to a vaccine, just as with food or any medication.

It is important we have the results of further investigations as soon as possible to establish the cause of this sad event
Department of Health

"At this stage we don't know what was the tragic cause of this child's death, so whether or not it's linked we cannot say, but these are the sort of things one would look for - a severe allergic reaction or more likely a coincidence."
When the national immunisation project was announced, there was some controversy about the selection of Cervarix over Gardasil, which is used by the majority of vaccination programmes worldwide.
Dr Pim Kon, medical director at GlaxoSmithKline UK, which makes Cervarix, said: "Our deepest sympathies are with the family and friends of the young girl.
"We are working with the Department of Health and MHRA (Medicines and Healthcare products Regulatory Agency) to better understand this case, as at this stage the exact cause of this tragic death is unknown."
The global pharmaceutical company added that the vast majority of suspected adverse reactions have related either to the symptoms of recognised side-effects or were due to the injection process and not the vaccine itself.

Safety record
Public Health Minister Gillian Merron said: "Our deepest sympathies are with the family. It is important we have the results of further investigations as soon as possible to establish the cause of this sad event."
Parents from the school react to the news of Natalie Morton's death
In the UK, about 3,000 women are diagnosed with cervical cancer every year and about 1,000 die from it.
The department said Cervarix had a strong safety record.
Shadow health secretary Andrew Lansley said the tragedy needed to be investigated "as a matter of urgency".
There are more than 100 types of HPV but only 13 of them are known to cause cancer.
Cervarix protects against two strains of HPV that cause more than 70% of cases of cervical cancer in women.
Vaccination is not compulsory and consent is required before it is administered to the under-16s.
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Page last updated at 16:58 GMT, Wednesday, 30 September 2009 17:58 UK
Keep faith with cancer jab plea

Natalie Morton
Natalie Morton died in hospital following a cervical cancer jab at school

Parents are being urged to carry on getting their daughters vaccinated against cervical cancer.

Senior government health officials have sought to allay fears following the death of a 14-year-old from Coventry.

Natalie Morton fell ill shortly after being given the Cervarix jab, but it has now emerged she had a serious underlying health condition.

Chief nursing officer Christine Beasley urged parents not to lose confidence, saying the jab could save lives.

She said: "My message to parents and to the young girls themselves is this a vaccination which will prevent you getting cervical cancer, which is a horrible disease, even if it is treated."

Protection

Public health minister Gillian Merron added: "We hope that girls continue to protect themselves against cervical cancer by having this vaccine."

Natalie was given the vaccination at school as part of the national vaccination programme. It protects against the human papilloma virus (HPV), a sexually transmitted disease linked to most cervical cancers.

Dr Caron Grainger, joint director of public health for NHS Coventry and Coventry City Council, said the results of a preliminary post-mortem examination had "revealed a serious underlying medical condition which was likely to have caused death".

Head teacher Dr Julie Roberts and the Bishop of Coventry on the death of Natalie Morton

"We are awaiting further test results which will take some time," she said. "However, indications are that it was most unlikely that the HPV vaccination was the cause of death."

Coventry postponed its immunisation clinics immediately after the death while the batch of vaccines was quarantined - this batch is now going to be tested by manufacturer GlaxoSmithKline.

In the meantime, Coventry is expecting to restart its clinics soon.

Natalie's death has left schoolmates and staff shocked and saddened, headteacher Dr Julie Roberts said.

She described Natalie as a "happy, easy-going child who worked hard".

A routine programme of vaccinating 12- and 13-year-old girls started in September 2008 using the Cervarix vaccine. A catch-up campaign is now under way for older girls.

It is thought about a million girls have already safely received the jab.


Adverse reactions to Cervarix
Pie chart showing adverse reactions to vaccine
Total number of reactions reported between April 2008 and 23 September 2009

Q and A: Cervical cancer

More than 1.4 million doses have been given out, of which there have been 4,657 suspected reactions reported, according to the Medicines and Healthcare products Regulatory Agency.

There are more than 100 types of HPV but only 13 of them are known to cause cancer.

Cervarix, licensed for use in Europe since September 2007, protects against two strains of HPV that cause more than 70% of cervical cancer cases.

In the UK, about 3,000 women are diagnosed with cervical cancer every year and about 1,000 die from it.

Vaccination is not compulsory and consent is required before it is administered to the under-16s.

Parents or young people concerned about the safety of any vaccine are being advised to speak to their GP, visit www.nhs.uk or call NHS Direct on 0845 46 47.

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女性の癌の死亡者で多いのは、乳癌、肺癌、大腸癌で、女性人口10万人当たり、それぞれ30人程度が毎年亡くなります。
それに対して、子宮頸がんは発症が毎年1万人、死亡が3500人程度で、女性人口10万人当たりの死亡者数は5.34人です。子の様なマイナーな癌に果たしてワクチン接種が必要かどうか不明です。さらにワクチンの有効期限が不明であり、メーカーは10−20年と言っているようですが、ワクチンの開発自体が最近のものなので、この数字は信憑性に欠けます。4−6年が確認されている年数の様です。免疫が無効になった後にパピローナウィルスに感染する可能性はかなり高いものと思われます。
WHOはワクチン接種プログラムを推進する様ですが、副作用の危険を冒してまで接種するワクチンでは無いと思われます。ましてはノースキャロライナ州の様に強制接種や、国が税金で補助をして打つようなワクチンではありません。
Bf
2009/11/17 15:55

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子宮頚がんワクチン接種後14才女子が死亡/英国 HPVワクチン 医師の一分/BIGLOBEウェブリブログ
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