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FDA 和 EMA 对 RSV 母亲疫苗接种的意见分歧:可能对全球死亡率产生的影响。

Disagreement FDA and EMA on RSV Maternal Vaccination: Possible Consequence for Global Mortality.

机构信息

From the Centre for Translational Immunology, University Medical Centre Utrecht, Utrecht, the Netherlands.

Division of Infectious Diseases, Department of Pediatrics, University Medical Centre Utrecht, Utrecht, the Netherlands.

出版信息

Pediatr Infect Dis J. 2024 Jan 1;43(1):e1-e2. doi: 10.1097/INF.0000000000004173. Epub 2023 Oct 11.

Abstract

The European Medicines Agency and the US Food and Drug Administration have recently approved a maternal vaccine for respiratory syncytial virus. The US Food and Drug Administration limits vaccination to later in pregnancy. Mathematical modeling demonstrates that this vaccination window may reduce the global mortality impact of the vaccine by 12%. Policymakers should carefully consider vaccine risks and benefits to safeguard vulnerable infants effectively.

摘要

欧洲药品管理局和美国食品药品监督管理局最近批准了一种用于呼吸道合胞病毒的母体疫苗。美国食品药品监督管理局将接种疫苗的时间限制在妊娠后期。数学模型表明,这一接种窗口可能使疫苗的全球死亡率影响降低 12%。政策制定者应仔细考虑疫苗的风险和效益,以有效地保护脆弱的婴儿。

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