作者：Yael Waknine 齣處：WebMD醫學新聞 　　August 20 2009 — 美國食品藥物管理局(FDA)宣布加速核準b型流感嗜血桿菌(Haemophilus influenza FDA加速核準新的Hib疫苗用於全國加強接種 - 趣味新聞網

發表日期 2009-09-04T06:41:08+08:00

     本帖最後由 goodcat1111 於 2009-9-4 12:46 編輯

作者：Yael Waknine
齣處：WebMD醫學新聞

August 20, 2009 — 美國食品藥物管理局(FDA)宣布加速核準b型流感嗜血桿菌(Haemophilus influenza type b，Hib)疫苗(商品名Hiberix，葛蘭素史剋藥廠製造)，用於15個月到4歲孩童之追加劑量。

此項核準是為瞭彌補2007年12月之後的全國疫苗短缺問題，當時廠商自主迴收PedvaxHIB以及Comvax(默剋製藥公司)，後續即産生短缺，美國四種核準用於一綫和加強免疫疫苗中的其中兩種疫苗，用於預防Hib-相關的侵犯性疾病，如腦膜炎。

當時，美國疾病控製預防中心(CDC)建議，暫時延後健康孩童的Hib追加劑量不會增加發病風險。

今年夏初，因為供應增加，CDC恢復常規的Hib追加劑量。不過，目前的供應還不足以因應那些延後追加劑量之所有孩童的疫苗需求。

FDA生物製劑評估與研究中心主任Karen Midthun醫師錶示，FDA基於該局的加速核準規定核準Hiberix。此核準將提供另一個安全且有效的疫苗，用於幫助確保有追加疫苗之需要時有適當的Hib疫苗供應。

Hiberix目前在全國約100個國傢中使用，FDA的核準是根據歐洲、拉丁美洲、加拿大的七個臨床研究，超過1,000名孩童的迴顧資料。施打此疫苗的孩童最常見的副作用包括注射部位疼痛與紅腫、發燒、煩躁、食慾降低、坐立不安。

核準之後，藥廠將進行上市後研究，和美國已經上市的Hib疫苗比較其安全性與免疫性，以確認該産品的臨床效益。

Accelerated FDA Approval of New Hib Vaccine Boosts Nationwide Supply

By Yael Waknine
Medscape Medical News

August 20, 2009 — The US Food and Drug Administration (FDA) has granted accelerated approval for a Haemophilus influenza type b (Hib) vaccine (Hiberix, GlaxoSmithKline) as a booster dose for children aged 15 months through 4 years.

The approval is intended to combat a nationwide shortage of the vaccine that began in December 2007 after a voluntary recall and subsequent product suspension of PedvaxHIB and Comvax (Merck and Company, Inc) — 2 of the 4 vaccines licensed in the United States for primary and booster immunization against Hib-related invasive diseases such as meningitis.

At that time, the US Centers for Disease Control and Prevention (CDC) recommended temporary deferral of the Hib booster dose for healthy children not at increased risk for disease.

Earlier this summer, the CDC reinstated the routine Hib booster dose because of an increase in supply. However, the current supply is not yet ample enough to support mass vaccination of all children whose boosters were deferred.

"The FDA approved Hiberix under the agency's accelerated approval pathway," said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research. "This approval will provide an additional safe and effective vaccine to help ensure that there is an adequate Hib vaccine supply during necessary catch-up vaccinations."

Hiberix is currently used in almost 100 countries worldwide, and its approval by the FDA was based on a review of data from 7 clinical studies of more than 1000 children in Europe, Latin America, and Canada. Adverse events most commonly reported in vaccinated children included pain and redness at the injection site, fever, fussiness, loss of appetite, and restlessness.

As a condition of the approval, the manufacturer will conduct a postmarketing study to confirm the product's clinical benefit by comparing its safety and immunogenicity to that of an Hib vaccine already licensed in the United States.

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