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zoom RSS 新型の肺炎球菌ワクチン FDAが認可/米国

<<   作成日時 : 2010/02/26 20:26   >>

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 FDAは水曜日、髄膜炎や肺炎などの細菌感染を予防する新たなワクチン Prevnar 13 を認可した。
 発展途上国では肺炎球菌で年間100万人の子どもが死亡している。米国では年に数十人が死亡し、100万人が耳の感染症を起こすという。
 ファイザーが発売するPrevnar 13は、肺炎球菌疾患の80%をカバーする従来のPrevnar 7に加え6タイプの細菌を予防し90%をカバーするという。Prevnar 7 はファイザーのベストセラー製品の一つで年間30億ドル近く販売されているが、Prevnar 13が2014年までに50億ドル以上の売上高になるだろうという。ファイザーは、コレステロール降下薬Lipitorが来年特許切れになった後の最大の稼ぎ頭になるだろうと期待している。
 最近数ヶ月で38ヶ国で認可された。
 小児にのみ認可されたが、成人でも2つの臨床試験が行われているという。年末までに承認申請をする予定。
 生後2ヶ月、4ヶ月、6ヶ月、12〜15ヶ月に筋注する。CDCは5才以下の全ての子どもに推奨している。新製品のため、1回108ドルで、旧製品の83ドルより30%高い。
 肺炎球菌19A型が細菌感染の10%を占めて5年前に抗生物質耐性となり脅威になりつつあったため新たなワクチンに追加した。
 GlaxoSmithKline、Synflorixによる競合ワクチンは欧州などで認可されているが19A型は含んでいない。

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Vaccine Approved for Child Infections
http://www.nytimes.com/2010/02/25/business/25vaccine.html
By DUFF WILSON
Published: February 24, 2010

The Food and Drug Administration on Wednesday approved Prevnar 13, an expanded version of a vaccine to protect children against more forms of bacterial infections that can cause meningitis, pneumonia and other diseases.

画像The new vaccine protects against a virulent subtype called strain 19A, a growing threat.

Health officials say such infections cause a million deaths a year in developing countries and dozens of deaths in the United States, along with ear infections in millions of infants.

Prevnar 13, from the drug giant Pfizer, adds protection against six types of bacteria to a current product, Prevnar 7, increasing its coverage to more than 90 percent of pneumococcal disease rather than the current product’s 80 percent coverage.

Prevnar 7 had worldwide sales approaching $3 billion, making it one of the Pfizer’s best-selling drugs, and Credit Suisse analysts predict Prevnar 13 will exceed $5 billion in sales by 2014. Pfizer is counting on it to become the company’s top revenue generator after its flagship drug, the cholesterol fighter Lipitor, loses patent protection next year. In recent months Prevnar 13 has been approved in 38 other countries.

While Prevnar 13, like Prevnar 7, is approved only for use in children, Pfizer is testing it on adults in two clinical trials that could lead to its use to vaccinate older people against bacterial infections, the company said. Pfizer may ask the F.D.A. to approve adult usage of Prevnar 13 by the end of the year, Geno Germano, president of Pfizer’s specialty care unit, said in an interview.

As with the older vaccine, Prevnar 13 is given by intramuscular injections at 2 months, 4 months, 6 months and between 12 and 15 months of age.

Pfizer said Prevnar 13 would be available within weeks to replace the older product. An immunization advisory committee for the Centers for Disease Control and Prevention, meeting in Atlanta on Wednesday, recommended that all children younger than 5 who received the Prevnar 7 vaccine get a supplemental dose of Prevnar 13 the next time they visited a doctor.

Pfizer told the committee it would charge $108 a dose for the new product, 30 percent higher than the $83 a dose it charged for Prevnar 7.

Vaccine products were the major attraction for Pfizer in its $68 billion purchase last year of Wyeth Pharmaceuticals, which developed the Prevnar vaccines. Pfizer, the world’s largest drug maker, is scrambling to diversify as patents of older products expire.

Testing of Prevnar 13 in adults includes an 85,000-person trial in the Netherlands to protect against pneumonia acquired outside of hospital settings, one of the most common infectious illnesses, particularly among older people, Dr. Emilio Emini, Pfizer’s chief vaccine officer, said in an interview.

Approval for adult use, said Mr. Germano of the specialty care unit, “would open up essentially hundreds of millions of additional patients who could benefit from the vaccine.” Pfizer has estimated it could add $1.5 billion in sales.

The new Prevnar vaccine protects against a virulent subtype of the Streptococcus pneumoniae bacteria called strain 19A, a growing threat to health that accounts for about 10 percent of the bacterial diseases. It became resistant to antibiotics about five years ago, Dr. Emini said, and is the major new strain attacked in the new product.

A competing vaccine from GlaxoSmithKline, Synflorix, is approved in Europe and some other markets but not in the United States and does not include the strain 19A. Prevnar is the only such vaccine approved for infants in the United States. Merck and Lederle Laboratories make pneumococcal vaccines approved for some adults and children ages 2 and older but not for the younger group, which has the highest rates of the disease.

The F.D.A. twice extended its review time for Prevnar 13, which Pfizer said was the most complex biological product ever submitted for regulatory review. An F.D.A. panel voted 10 to 1 in November to approve it, with one member expressing concern about safety, especially about adverse reactions like redness at the injection site and occasional fever.

The illnesses caused by the Streptococcus pneumoniae bacteria include meningitis, an inflammation of the brain covering; sepsis or bloodstream infection; pneumonia and ear infections. The bacteria have evolved, frustrating efforts to wipe them out.

Pfizer plans to expand the childhood vaccine usage in other markets, including developing countries, through the Global Alliance for Vaccines and Immunisation, at a much lower price, Mr. Germano said.

The World Health Organization says at least a million children worldwide die each year of pneumococcal disease, most of them very young children in developing countries, making it the leading cause of vaccine-preventable death.

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