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

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.
Competing Interests: L.J.B. has regular interaction with pharmaceutical and other industrial partners. He has not received personal fees or other personal benefits. UMCU has received major funding (>€100,000 per industrial partner) for investigator-initiated studies from AbbVie, MedImmune, AstraZeneca, Sanofi, Janssen, Pfizer, MSD and MeMed Diagnostics. UMCU has received major funding for the RSV GOLD study from the Bill and Melinda Gates Foundation. UMCU has received major funding as part of the public-private partnership IMI-funded RESCEU and PROMISE projects with partners GSK, Novavax, Janssen, AstraZeneca, Pfizer and Sanofi. UMCU has received major funding by Julius Clinical for participating in clinical studies sponsored by MedImmune and Pfizer. UMCU received minor funding (€1,000–25,000 per industrial partner) for consultation and invited lectures by AbbVie, MedImmune, Ablynx, Bavaria Nordic, MabXience, GSK, Novavax, Pfizer, Moderna, AstraZeneca, MSD, Sanofi, Janssen. L.J.B. is the founding chairman of the ReSViNET Foundation. Since April 1, 2021, Louis has been given a new position as medical scientific division manager of the Children’s Division of the Wilhelmina Children’s Hospital in Utrecht. The other authors have no conflicts of interest to disclose.
(Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)