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

Joukje E Willemsen; José A M Borghans; Louis J Bont; Julia Drylewicz

doi:10.1097/INF.0000000000004173

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

Joukje E Willemsen, José A M Borghans, Louis J Bont, Julia Drylewicz^*

^*Corresponding author for this work

Research output: Contribution to journal › Comment/Letter to the editor › Academic › peer-review

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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.

Original language	English
Pages (from-to)	e1-e2
Journal	The Pediatric infectious disease journal
Volume	43
Issue number	1
DOIs	https://doi.org/10.1097/INF.0000000000004173
Publication status	Published - 1 Jan 2024

Keywords

Abrysvo vaccine
EMA guidelines
FDA guidelines
LMICs
RSV
infant mortality
maternal vaccination
vaccine administration timing
vaccine impact
vaccine licensure
vaccine recommendations

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disagreement_fda_and_ema_on_rsv_maternal.4Final published version, 300 KBLicence: CC BY

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title = "Disagreement FDA and EMA on RSV Maternal Vaccination: Possible Consequence for Global Mortality",

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.",

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AU - Bont, Louis J

AU - Drylewicz, Julia

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AB - 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.

KW - Abrysvo vaccine

KW - EMA guidelines

KW - FDA guidelines

KW - LMICs

KW - RSV

KW - infant mortality

KW - maternal vaccination

KW - vaccine administration timing

KW - vaccine impact

KW - vaccine licensure

KW - vaccine recommendations

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M3 - Comment/Letter to the editor

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

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Keywords

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