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zoom RSS Hibワクチン(髄膜炎ワクチン)120万本が回収/米国

<<   作成日時 : 2007/12/14 20:35   >>

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画像米国で、メルク社の Hibワクチン(髄膜炎ワクチン)100万本が製造過程での細菌汚染により回収されるという。ワクチン後進国日本では定期接種には入っていない。
 メルク社は毎年米国で使われる1400万のHibワクチンの約半分を供給している。約4ヶ月の生産に相当し、約1年分は疑わしいため少なくとも次の10月まで供給を予定せず、つまり、約2年は生産ができないことを意味するという。
 Hib感染(インフルエンザ桿菌b型)による乳幼児の細菌性髄膜炎は、初期診断や治療が難しい。米国では、このワクチンによる定期予防接種の導入により、Hib罹患率が100分の1にまで減少したという。1998年、世界保健機関(WHO)がHibワクチンの乳児への定期接種を推奨する声明を出し、現在では世界100カ国以上で使用されるようになっている。
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インフルエンザ菌
出典: フリー百科事典『ウィキペディア(Wikipedia)』
 インフルエンザ菌(Haemophilus influenzae)とは、主に呼吸器や中耳に感染する細菌の1種である。インフルエンザという名称が付けられてはいるが、インフルエンザの病原体ではない。
歴史
 1800年代のインフルエンザの大流行の際に、原因菌として分離された細菌である。そのためインフルエンザ菌という名称が付いているが、その後否定されたため名称だけが残ることとなった(インフルエンザの真の病原体は、RNAウイルスのインフルエンザウイルスである)。ただし、インフルエンザに引き続いて二次的感染を起こすことがある。1995年にH. influenzae Rd.株の全ゲノム配列が解析され[1]、その後データが改定されることにより、本菌のゲノムは1,830,138塩基の環状染色体からなり、染色体上には1,657のタンパク質配列がコードされている事が明らかとなった。なお、インフルエンザ菌は、初めて全ゲノム配列が明らかとなった生物である。
性状
 ヘモフィルス属のグラム陰性桿菌である。フィラメント状や球菌状の形態も呈する多形性という性質がある。発育因子としてX因子(ヘミン)とV因子(NAD)の両方を必要とする。ヘミン(hemin)を要求することは属名(Haemophilus)の由来ともなっている。通常はブレインハートインフュージョン等の培地にヘミンとNAD、または羊脱線維血液を加えて培養する。
診断
感染病巣からの培養による菌の分離、同定が基本である。血清型b型は迅速診断法として共同凝集反応、酵素抗体法、PCR法などが用いられる。ラテックス凝集法はb型菌の迅速診断法として広く行われており、髄液(髄膜炎の場合)、尿(敗血症の場合)などを対象とする。
治療
 一般にはペニシリン系抗生物質のアンピシリンなどが有効である。ただし、後述のとおり耐性菌の出現が問題となっている。
ワクチン
 インフルエンザ菌b型の莢膜多糖体抗原を輸送蛋白に結合させたワクチンは、b型菌による重症感染症の予防に極めて有効である。世界100カ国以上でこのワクチンは導入されており、導入された国ではインフルエンザ菌b型による髄膜炎、喉頭蓋炎がほとんど消失している。
 2007年1月26日、Hib莢膜多糖体蛋白結合ワクチン(販売名アクトヒブ?)が厚生労働省により承認され、2003年時点で問題となっている乳幼児のインフルエンザ菌感染への予防の切り札となることが期待されている。ただし、発売当初は任意接種となり、公費負担はなく保険も適応とならないため全額自費負担となる。接種回数は3回(4-8週間間隔)となるため、家族の経済的負担は3万円程度と大きいとされている。同質問趣意書をめぐる応答を解釈するならば、予防接種法による接種になるまでは、いま少し時間がかかるものと考えるのが妥当と思われる。
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Vaccine Recall: What Parents Need to Know
http://www.time.com/time/health/article/0,8599,1694265,00.html
Merck announced that it is voluntarily recalling 1 million doses of two common childhood vaccines, routinely given to children under 5. Here's everything you need to know about the recall.

Which vaccines are affected?

Merck is pulling 11 lots of PedvaxHIB and two lots of COMVAX. PedvaxHIB is a vaccine that protects against infection with haemophilus influenzae type B (Hib), the bacteria that causes meningitis, pneumonia, and blood stream infections. The COMVAX vaccine protects against haemophilius b and hepatitis B, a virus that can cause liver disease.

Why are the vaccines being recalled?

During a routine inspection of their manufacturing process, Merck officials found that some equipment was contaminated with a bacteria called Bacillus cereus.

Is haemophilus influenzae the same bug responsible for the flu?

No. Haemophilus influenzae is a bacterium, while the microbes that cause the flu are viruses. The Hib vaccine recall does not affect flu vaccines.

How can I find out whether my child was vaccinated with one of the recalled shots?

Your doctor will know whether he or she received doses from the lots in question. The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) are contacting all health care providers and asking them to return unused vaccines from these lots.

If my child was vaccinated with a vaccine from one of the affected lots, will he get sick?

Probably not. Officials at the CDC and FDA stress that there is no serious health risk associated with this recall. The vaccines themselves have not been contaminated so far, but Merck decided to pull all the shots made on those machines as a precaution.

What if the vaccines are contaminated ― what signs or symptoms should I look for?

If your child does get sick from the vaccine, the symptoms of a bacterial infection ― redness at the injection site, swelling, fever ― will likely appear within the first few days after receiving the shot. "Any problems should appear in the first several days, and by the end of a week if there are no symptoms he should definitely be out of the woods," says Dr. Anne Schuchat, director of CDC's National Center for Immunization and Respiratory Diseases.

Will my child have to be re-vaccinated?

No. The manufacturing problem does not affect the strength or effectiveness of the vaccine. "It's important to understand that the recall has nothing to do with the potency of the vaccine," says CDC director Dr. Julie Gerberding. "Children who received the vaccine are protected against haemophilus. There is no need to re-immunize."

What if my child has not been vaccinated yet? Will there be a shortage of the vaccine because of the recall?

Yes. Officials at Merck and sanofi Pasteur ― the companies that produce the 14 million doses of Hib vaccine administered each year ― are working with CDC officials to ensure that the shortage is addressed as quickly as possible, but some doctors who received their entire supply of vaccine from Merck may not have vaccines for a few weeks. CDC is making available some doses from its national stockpile, an emergency supply created for just such situations, and sanofi Pasteur is increasing production to make up for some of the shortfall.

If children can't get immunized, is there a danger that we will see more meningitis outbreaks?

Probably not. Immunization rates are so high in the U.S. ― 94% of toddlers are up to date on their Hib vaccinations ― that it would take some time for a widespread infection to take hold. "We have a nice cushion because of our high immunization rates," says Schuchat. "That cushion of protection can buy us some time while we are dealing with the supply problem. We are at much lower risk than we would have been before the [childhood] vaccination system was so strong."

For more information, go to the Centers for Disease Control website.

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Vaccine recall sparks fears over kids’ safety
Doctors rush to stock up on Hib after manufacturers suspend production
http://www.msnbc.msn.com/id/22249901
updated 5:51 p.m. ET Dec. 13, 2007

TRENTON, N.J. - Pediatricians rushed to stock up on a crucial baby shot Thursday, a day after one of the nation’s top vaccine manufacturers announced it was recalling 1.2 million doses and suspending production indefinitely.

Meanwhile, worried parents were calling doctors’ offices to ask whether their children are safe if they recently got the Hib vaccine, which protects against meningitis, pneumonia and other life-threatening and disabling bacterial diseases. Parents were told there’s virtually no chance of anything but swelling and redness around the injection, which would have happened within a week; there have been no such reports.

But health officials are still scrambling over how to address the shortage, caused by a sterility problem at a Merck & Co. vaccine factory in West Point, Pa.
Story continues below ↓advertisement

“This one’s a huge challenge,” said Dr. Lance Rodewald, head of immunization services at the Centers for Disease Control and Prevention.

Rodewald said the CDC and other medical groups are weighing options to stretch the supply of Hib vaccine from the only other manufacturer, Sanofi Pasteur, and waiting to hear whether it can boost production or shift some doses here that normally would be sold overseas. He hopes to have recommendations next week.

The American Academy of Pediatrics is advising its 60,000 members to try to order now from Sanofi Pasteur, and if they run short, to delay the booster shot usually given at 12-15 months.

Merck, based in Whitehouse Station, N.J., supplies about half the 14 million doses of Hib vaccine used in the U.S. each year. It said that in addition to the doses recalled ― roughly four months of production ― it has quarantined nearly a year’s worth of other, possibly suspect doses and doesn’t expect to supply any more until at least next October. That means roughly two years of its normal production is unavailable.

“The math doesn’t look good,” said Dr. Kathy Moore, a solo practitioner in Tyler, Texas. “There’s going to be a problem real fast.”

Dr. Herschel Lessin, a partner in the seven-office Children’s Medical Group in the Poughkeepsie, N.Y., area, said all but a handful of the Hib doses in their stock were included in the recall.

“This pretty much wipes us out,” he said.

Lessin and other doctors said Sanofi Pasteur is saying at best they can get up to 50 doses per office ― for now.

“It may not be adequate,” said Dr. Michael Segarra of North Brunswick Pediatrics in New Jersey, which lost a third of its stock to the recall.

Dr. Kenneth Polin of Town and Country Pediatrics in the Chicago area, said he expects rationing and told his staff “to order massive quantities right now.” But it was already too late, and they could only place a small order.

Polin and some other doctors who have long bought their Hib vaccine from Sanofi Pasteur were hoping to get priority over Merck’s customers.

Sanofi Pasteur spokeswoman Donna Cary said the company, a unit of Paris-based drugmaker Sanofi-Aventis SA, is trying to provide for doctors’ immediate needs but is limiting them to a “reasonable” 30-day supply. She said call volume was up 45 percent Thursday.

Merck has said it initiated the recall as a precaution because a routine test in October found bacterial contamination on production equipment; none has been found in vaccine so far.

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The company quarantined all doses of Hib vaccine produced since the last “clean” sterility test, in November 2006. Further investigation showed the most likely cause of the problem was a manufacturing change made in July 2006, so it recalled all doses made between July 2006 and November 2006. Those recalled doses were distributed beginning in April.

“There absolutely is going to be a severe shortage,” said Dr. Jill Stoller of Chestnut Ridge Pediatrics in Woodcliff Lake, N.J. “Vaccines should be made by the government and distributed by the government,” not the free market.

The CDC’s Rodewald said before the vaccine was introduced in the mid-1980s, there were about 20,000 U.S. cases a year of invasive Hib ― short for Haemophilus influenza type B ― which can cause brain damage, deafness and death.
© 2007 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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