ST LOUIS (MD Consult) - As of February 4, 2009, Novartis Vaccines and Diagnostics Limited has recalled several lots of Fluvirin (influenza virus vaccine) Luer-Lok prefilled syringes.
The lot numbers are 878771P, 878772P, 878773P, 878775P, and 878776P. They all expire in May 2009.
Novartis has asked customers to immediately discontinue using and return any remaining doses from these 5 lots of Fluvirin Luer-Lok prefilled syringes.
Routine stability testing of Fluvirin in prefilled Luer-Lok syringes revealed a minor deviation in the potency of the A/Brisbane (H1N1) component of the vaccine. The vaccine met all required specifications at the time of release and has been monitored in monthly time intervals during its shelf life. It has consistently met specifications until the most recent test point in early January 2009 that identified a minimal decrease in H1N1 antigen content.
The US Food and Drug Administration, the Centers for Disease Control and Prevention, and Novartis Vaccines have agreed that no public health impact is expected because 1) all of the affected vaccine was shipped when the vaccine met potency requirements, 2) most influenza vaccine in the United States is administered during October and November, months when the vaccine met potency requirements, and 3) the decrease in antigen content is small and would have a negligible if any effect on immune response to vaccination. Revaccination of patients who were vaccinated with the affected lots is not necessary.
圣路易斯 (MD Consult)——截至2009年2月4日，诺华疫苗与诊断试剂有限责任公司已经发布了数个批次的Fluvirin（流感病毒疫苗）Luer-Lok预充式注射器的召回令。
批次号分别为878771P、878772P、878773P、878775P和878776P，有效期均截止到2009年5月。
诺华公司要求消费者立刻停止使用这些药物，并将上述5个批次剩余的Fluvirin Luer-Lok预充式注射器返还给公司。
对用预充式Luer-Lok注射器装载的Fluvirin的常规稳定性检测发现，疫苗的A/布里斯班（H1N1）组分的效力发生了微小变化。该疫苗在出厂时符合所有检测要求，上架期间以每月一次的频度接受监测也一直符合要求，直至最近的一次检测（2009年1月初）发现，H1N1抗原含量有轻微下降。
美国FDA、美国疾病控制与预防中心（CDC）和诺华疫苗一致认为，上述疫苗不会对公众健康造成影响，原因如下：1)上述批次疫苗都是在其效力符合要求的时候出厂的；2)美国的大多数流感疫苗都是在去年10月和11月期间接种的，当时的疫苗还是符合效力要求的；3)抗原含量的降低幅度很小，即便对疫苗所致免疫应答产生影响也可忽略不计。已接种上述批次疫苗的患者没有必要再次接种疫苗。
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