从9价值人乳头瘤病毒疫苗怀孕注册 (2014-2021) 的最终数据的总结
Cathy Hardalo1, Ann Marko2, Brittany Sciba2
1Merck & Co., Inc., Rahway, NJ, USA.
Human vaccines & immunotherapeutics
|October 15, 2025
概括
在怀孕早期无意中注射的9价值人类乳头瘤病毒 (9vHPV) 疫苗没有显示出重大出生缺陷或流产的风险增加. 这一安全性发现支持其在生育年龄的妇女中使用.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 产科和妇科 产科和妇科
- 公共卫生 公共卫生
背景情况:
- 这种9价值人类乳头瘤病毒 (9vHPV) 疫苗针对的是HPV类型6/11/16/18/31/33/45/52/58.
- 虽然不建议孕妇使用,但由于疫苗的目标年龄范围,可能会发生意外暴露.
- 建立了一个怀孕登记册,以监测怀孕期间暴露于9vHPV疫苗后的结果.
研究的目的:
- 评估怀孕不良结果的风险,包括先天性异常和流产,在怀孕早期意外接种9vHPV疫苗后.
- 分析从营销后怀孕登记册中获得的9vHPV疫苗暴露自发报告的数据.
主要方法:
- 在美国报告9vHPV疫苗暴露的孕妇的潜在招生情况 (2014年12月 - 2021年3月).
- 随访怀孕完成以记录主要结果:先天性异常,活产,胎儿死亡,选择性终止和流产.
- 基于已知的怀孕结果计算事件率.
主要成果:
- 在180个潜在的怀孕中,70个怀孕的结果已知.
- 记录了66例活产 (67例婴儿) 和3例流产 (4.3%的比率).
- 观察到3种主要的出生缺陷 (4.5%的率);没有特定的异常模式被确定.
结论:
- 来自美国9vHPV疫苗怀孕登记处的研究结果并不表明出现重大出生缺陷或流产的风险增加.
- 没有明显的先天性异常模式,表明9vHPV疫苗在怀孕期间暴露的不良影响.
- 结果与先前的HPV疫苗临床试验和许可后数据一致.
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