ST LOUIS (MD Consult) - On August 19, 2009, GlaxoSmithKline and the US Food and Drug Administration (FDA) announced the accelerated approval of Hiberix, a vaccine for the prevention of infection caused by the bacteria Haemophilus influenzae type b (Hib). Infection with Hib can cause meningitis, a disease that can be severe and sometimes fatal. The vaccine is intended to be used as a booster dose for children aged 15 months through 4 years.

The FDA's decision to grant accelerated approval to Hiberix was prompted by a nationwide shortage of Hib vaccine that began in December 2007. The shortage occurred as the result of a voluntary recall by the manufacturer and subsequent production suspension of PedvaxHIB and Comvax, 2 of 4 vaccines licensed in the United States for primary and booster immunization against invasive disease caused by Hib. This shortage resulted in a recommendation by the US Centers for Disease Control and Prevention (CDC) to temporarily defer the Hib vaccine booster dose for children who were not at high risk for infection, until the vaccine supply could be restored. This deferral was in effect from December 18, 2007, through June 25, 2009.

Hiberix is used in nearly 100 countries. The FDA's approval of the vaccine was granted on the analysis of data from 7 clinical studies conducted in Europe, Latin America, and Canada that involved more than 1,000 children. As part of the approval, GlaxoSmithKline has agreed to conduct a post-marketing study in the United States to evaluate the safety and immunogenicity of primary and booster vaccination with Hiberix compared with a Hib vaccine already licensed in the United States. The study is intended to confirm the clinical benefit of booster immunization with Hiberix in accordance with the FDA's accelerated approval regulations, and to provide additional data on Hiberix for young infants.

In clinical studies, adverse events in children receiving Hiberix included pain and redness at the injection site, fever, fussiness, loss of appetite, and restlessness. A severe allergic reaction (eg, anaphylaxis) after a previous dose of any Hib or tetanus toxoid–containing vaccine or any component of Hiberix is a contraindication.

The CDC recommends that children receive the complete Hib vaccination series. The series includes a booster dose in the second year of life, in addition to a complete primary series of immunization during infancy.

圣路易斯（MD Consult）——2009年8月19日，葛兰素史克公司和美国食品药品管理局（FDA）宣布，一种用于预防B型流感嗜血杆菌（Hib）感染的疫苗Hiberix，，已提前获得批准。Hib感染可引起脑膜炎，后者病情可呈重度，有时甚至可致死。该疫苗适合作为15月龄儿童的强化免疫，作用可持续4年。

在美国Hib疫苗（起于2007年12月）短缺的情况下，FDA做出了提前批准Hiberix的决定。短缺原因为生产厂家自愿召回以及随后的Pedvax HIB和Comvax生产中止。在美国有4种针对Hib所致的侵袭性疾病的初级免疫疫苗和强化免疫疫苗获准，Pedvax HIB和Comvax是其中的两种。此短缺促使美国疾病预防控制中心（CDC）建议将用于非感染高危儿童的Hib强化疫苗临时推迟至疫苗供应量恢复之后。推迟的有效期为2007年12月18日至2009年6月25日。

Hiberix在近100个国家使用。FDA批准该疫苗是基于7项临床研究的数据分析结果，这些研究在欧洲、拉丁美洲以及加拿大逾1,000个儿童中开展。作为审批内容的一部分，葛兰素史克公司已同意在美国进行售后研究，将Hiberix的初级和强化免疫与已在美国获准上市的Hib疫苗进行比较，以评价前者的安全性和免疫原性。这项研究旨在证实Hiberix强化免疫的临床获益符合FDA的加速批准法规，并提供婴幼儿使用Hiberix的其他资料。

在临床研究中，接受Hiberx疫苗的儿童可发生注射部位疼痛和发红、发热、易激惹、食欲不振以及烦躁不安等不良反应。其禁忌证为先前注射一剂含有Hiberix疫苗或Hiberix任何成分的任何Hib或破伤风类毒素后发生严重过敏反应（即过敏反应）。

CDC建议对儿童实施完整的Hib疫苗接种方案，其中除了包括在婴儿期完整的初级免疫接种之外，还包括于出生次年进行强化免疫接种。

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