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Exposure to MF59-adjuvanted influenza vaccines during pregnancy-A retrospective analysis

机译：妊娠期间接触MF59辅助流感疫苗的回顾性分析

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Pregnant women are at increased risk for complications and death associated with pandemic H1N1 influenza infection and they are prioritized for vaccination by public health authorities. Few data are available on the safety of adjuvants as components of pandemic vaccines that could be given systematically to pregnant women. Here we review nonclinical and clinical data on pregnancy outcomes associated with exposure to MF59 (R), an adjuvant used in licensed HI NI pandemic vaccines. Evaluation of the reproductive and developmental toxicity of MF59 alone and of a candidate MF59-adjuvanted H5N1 vaccine in animals demonstrated no evidence of teratogenicity OF impact On fetal or early perinatal development. The clinical trial database encompassing all Novartis vaccine studies from 1991 to 2009 was searched to compare pregnancy outcomes in subjects exposed to MF59-adjuvanted or unadjuvanted influenza vaccines. Analysis of the clinical trial database found that the distribution of pregnancy outcomes (normal, abnormal, or ending in induced abortion) was similar in subjects exposed to MF59-adjuvanted and unadjuvanted influenza vaccine at any time in pregnancy and also, specifically, in early pregnancy: the respective proportions reported as a normal pregnancy outcome were 70% and 75%, respectively, overall, and 61% and 68%, respectively, in early pregnancy. Although data from the clinical database are too few to draw definitive conclusions on risks associated with exposure to MF59-adjuvanted influenza vaccines during pregnancy, available observations, so far, indicate no signals of a risk. Further data will be forthcoming from planned post-licensure studies of adjuvanted H1N1 vaccines as they are distributed in the pandemic response.
机译：孕妇患大流行H1N1流感感染相关并发症和死亡的风险增加，因此，公共卫生当局将孕妇列为优先接种疫苗。关于佐剂作为大流行疫苗成分的安全性的数据很少，可将其系统地给予孕妇。在这里，我们回顾了与已许可的HI NI大流行疫苗中使用的佐剂MF59（R）相关的妊娠结局的非临床和临床数据。单独评估MF59和候选MF59佐剂的H5N1疫苗对动物的生殖和发育毒性，没有证据表明对胎儿或围产期早期发育有致畸作用。搜索了涵盖1991年至2009年所有诺华疫苗研究的临床试验数据库，以比较暴露于MF59佐剂或未佐剂的流感疫苗的受试者的妊娠结局。对临床试验数据库的分析发现，在怀孕期间的任何时候，特别是在早孕期，暴露于MF59佐剂和未佐剂的流感疫苗的受试者，妊娠结局（正常，异常或人工流产结束）的分布相似：报告为正常妊娠结局的总比例分别为总体的70％和75％，以及早期妊娠的分别为61％和68％。尽管来自临床数据库的数据太少，无法就怀孕期间与MF59佐剂型流感疫苗接触相关的风险得出明确的结论，但到目前为止，现有观察结果并未表明存在风险信号。计划中的H1N1佐剂疫苗的许可后研究将提供进一步的数据，因为它们在大流行反应中分布。

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