Executive Board of the Fondazione Allineare Sanità e Salute, Fondazione Allineare Sanità e Salute , Milan , Italy.
Hum Vaccin Immunother. 2019;15(9):2168-2170. doi: 10.1080/21645515.2019.1605818. Epub 2019 May 24.
Valid evidence does not support universal influenza vaccination for pregnant women, the LTE objections are unfounded. The observational evidence is less valid than that from RCTs: important safety signals in all the RCTs require high consideration. In RCTs, influenza vaccinated women have mostly local adverse effects, while their offspring shows a nonsignificant excess of deaths, and a significant excess of serious presumed/neonatal infections in the larger RCT. Several Authors have financial relationships with vaccine producers, several conclusions omit the safety signals. A cited systematic review has methodological problems and excluded important published RCTs. Waiting for new independent RCTs, the precautionary principle suggests avoiding to promote pregnant women vaccination. Health services could offer it highlighting existing uncertainties, with balanced informations allowing informed choices.
目前尚无有力证据支持对孕妇进行常规流感疫苗接种,反对这种做法的观点是没有根据的。观察性证据的可靠性不及随机对照试验(RCT):所有 RCT 中均出现了重要的安全性信号,必须高度关注。在 RCT 中,流感疫苗接种的孕妇大多仅有局部不良反应,而其后代的死亡风险无显著增加,但在较大规模的 RCT 中,严重疑似/新生儿感染的风险显著增加。一些作者与疫苗生产商存在财务关系,部分结论忽略了安全性信号。被引用的系统评价存在方法学问题,且排除了一些重要的已发表 RCT。鉴于目前尚无新的独立 RCT,我们应遵循预防原则,避免推广孕妇接种流感疫苗。医疗服务机构可以提供该疫苗,但应强调现有不确定性,提供平衡的信息,以方便做出知情选择。