FDA批准新型四价流感疫苗

圣路易斯(MD Consult)——2013年6月10日，赛诺菲巴斯德公司宣布，美国食品药品管理局(FDA)已经批准了Fluzone Quadrivalent(一种灭毒流感疫苗)用于年龄≥6个月者预防流感。该疫苗针对2个甲型流感毒株和2个乙型流感毒株发挥防御作用。

据赛诺菲公司称，美国季节性流感疫苗曾经仅包含2个病毒株(1个甲型流感病毒株和1个乙型流感病毒株)，这种状况到1978年方有改观，当时相关部门决定在流感疫苗中再加入1种甲型流感病毒株，以提高对同时流行的2种甲型流感的预防作用。在过去35年中，流感疫苗一直为三价疫苗，针对3种流感病毒发挥防御作用。然而，自从2001~2002流感季节以来，2种不同的乙型流感(维多利亚株和山形株)一直合并流行，只是流行状况有所不同，这使得人们很难预测下一个流感季节的主要乙型流感病毒株。在过去12个流感季节中的6个季节中，主要流行的乙型病毒株未被包含在疫苗中。即使在选择了正确的乙型流感病毒株制作疫苗的年份里，仍会发生由疫苗中漏掉的乙型病毒株引起的流感，这很可能降低了疫苗对流感病毒的整体有效性。

接种Fluzone Quadrivalent疫苗最常见的局部和全身不良反应包括接种部位疼痛、红斑和肿胀；肌痛、不适及发烧(年幼儿童易怒、哭喊和昏睡)。这种疫苗不宜用于对任何疫苗组分(包括鸡蛋蛋白)或对既往任何一剂流感疫苗有严重过敏反应史者。

用于2013~2014流感季节的Fluzone Quadrivalent疫苗将在美国上市，盛放于预充注射器及单剂安瓿中，经肌内注射接种。Fluzone Quadrivalent疫苗不含防腐剂，并且产品中无天然橡胶乳胶成分。

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ST LOUIS (MD Consult) - On June 10, 2013, Sanofi Pasteur announced that the US Food and Drug Administration (FDA) has approved Fluzone Quadrivalent, a virus-inactivated vaccine indicated for the prevention of influenza in persons aged 6 months and older. The vaccine offers protection against two A and two B strains of influenza.

According to Sanofi, seasonal influenza vaccines in the United States contained only 2 strains (1 strain of type A influenza and 1 strain of type B influenza) until 1978, when the decision was made to incorporate a second type A influenza strain to help provide protection against both A strains that were co-circulating. For the past 35 years, influenza vaccines have been trivalent to help protect against 3 strains of influenza virus. However, since the 2001-2002 season, 2 distinct influenza B types (the Victoria and Yamagata lineages) have co-circulated with varying prevalence, making it difficult to predict the next season's dominant B lineage strain. In 6 of the past 12 seasons, the dominant circulating B strain was from the B lineage not selected for the vaccine. Even in years where the correct B-lineage strain was selected for the vaccine, some influenza disease was caused by the B lineage omitted from the vaccine, likely reducing the overall vaccine effectiveness against circulating influenza viruses.

The most common local and systemic adverse reactions to Fluzone Quadrivalent vaccine include pain, erythema, and swelling at the vaccination site; myalgia, malaise, headache, and fever (irritability, crying and drowsiness in young children). The vaccine should not be administered to persons who have experienced severe allergic reactions to any vaccine component, including egg protein, or to a previous dose of any influenza vaccine.

Fluzone Quadrivalent vaccine will be available in the United States for the 2013-2014 influenza season in prefilled syringes and single-dose vials for intramuscular administration. These presentations of Fluzone Quadrivalent vaccine do not contain preservatives and are not made with natural rubber latex.