FDA批准无鸡蛋成分的重组Flublok流感疫苗

圣路易斯(MD Consult)——2013年1月16日，Protein Sciences宣布美国食品药品管理局(FDA)已批准Flublok用于预防18~49岁成人流感。Flublok是一种新型蛋白疫苗，通过100%非鸡蛋系统制备。

该产品可快速制备，不存在传统疫苗生产过程中伴随的感染风险。Flublok可通过每年调整所含的流感毒株血凝素抗原，针对最新流感毒株提供预防作用。因为Flublok采用重组技术生产(例如，不使用真正的流感病毒)，不存在因病毒暴露所致的流感风险。该产品为高度纯化疫苗，所含活性成分量是传统流感疫苗的3倍。Flublok不含防腐剂(如硫柳汞)、抗生素或佐剂。

在临床试验中，最常见的注射部位反应是疼痛，最常见的全身不良反应是头痛、乏力和肌痛。受试者主动报告的最常见不良事件为鼻咽炎、上呼吸道感染、头痛、咳嗽、鼻塞、咽喉疼痛和鼻溢。

Flublok为无菌溶液，以单剂量0.5 ml瓶装上市。该产品采用单次肌注给药，注射部位以三角肌为佳。Flublok将在2013~2014流感季节广泛上市，本次流感季节仅有限供应。

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ST LOUIS (MD Consult) - On January 16, 2013, Protein Sciences announced that the US Food and Drug Administration (FDA) has approved Flublok, a vaccine indicated for the prevention of influenza in adults aged 18 to 49 years. Flublok is a novel protein vaccine and is made in a 100% egg-free system.

The product can be made quickly and without the infectious risk traditionally associated with vaccine manufacture. Flublok is tailored annually to provide protection against the latest strains of influenza by containing the corresponding hemagglutinin antigens for those strains. Because Flublok is made using recombinant technology (ie, without the use of actual influenza virus), the risk of acquiring influenza from viral exposure is nonexistent. The product is highly purified and boasts 3 times the amount of active ingredient in traditional influenza vaccines. Flublok contains no preservatives (eg, thimerosal), antibiotics, or adjuvants.

In clinical trials, the most common injection-site reaction was pain, and the most common solicited systemic adverse reactions were headache, fatigue, and myalgia. The most frequent unsolicited adverse events in study patients were nasopharyngitis, upper respiratory infection, headache, cough, nasal congestion, pharyngolaryngeal pain, and rhinorrhea.

Flublok is a sterile solution supplied in single-dose 0.5 mL vials. The product is administered as a single intramuscular injection, preferably in the deltoid muscle. Flublok will be widely available for the 2013-2014 influenza season and is available in limited supply for the current season.