PMID- 36456431 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230803 IS - 2529-993X (Electronic) IS - 2529-993X (Linking) VI - 41 IP - 7 DP - 2023 Aug-Sep TI - Adverse events in pregnant women with the tetravalent influenza vaccine obtained from cell cultures. PG - 420-422 LID - S2529-993X(22)00254-4 [pii] LID - 10.1016/j.eimce.2022.11.005 [doi] AB - Influenza vaccination in pregnant women shows a clear benefit/risk ratio. Influenza vaccines are currently being developed using new platforms. It is essential to analyse the safety of these new vaccines in this population group, underrepresented in clinical trials. In the 2019-2020 season, a vaccine obtained in cell culture was recommended to pregnant women in two autonomous communities. Information is collected from the vaccination and pharmacovigilance centres of both communities. The reporting rate of adverse events (AEs) after vaccination in pregnant women was 4.02/100,000 doses administered, and in non-pregnant women aged 18-64 years it was 5.9/100,000 doses administered. The rate of AE reported was 8.04 and 17.74 respectively. No spontaneous abortions, prematurity or foetal malformations were reported. This analysis suggests the safety in pregnant women of the influenza vaccine obtained from cell cultures. CI - Copyright (c) 2022. Published by Elsevier Espana, S.L.U. FAU - Carreras, Juan Jose AU - Carreras JJ AD - Area de Investigacion en Vacunas, FISABIO - Salud Publica, Valencia, Spain. FAU - Lluch, Jose Antonio AU - Lluch JA AD - Direccion General de Salud Publica y Adicciones, Conselleria de Sanitat Universal i Salut Publica, Valencia (Comunidad Valenciana), Spain. FAU - Taboada, Jose Antonio AU - Taboada JA AD - Programa Galego de Vacinacion, Direccion Xeral de Saude Publica, Conselleria de Sanidade, Santiago de Compostela (Galicia), Spain. FAU - Pastor-Villalba, Eliseo AU - Pastor-Villalba E AD - Direccion General de Salud Publica y Adicciones, Conselleria de Sanitat Universal i Salut Publica, Valencia (Comunidad Valenciana), Spain. FAU - Nartallo-Penas, Victoria AU - Nartallo-Penas V AD - Programa Galego de Vacinacion, Direccion Xeral de Saude Publica, Conselleria de Sanidade, Santiago de Compostela (Galicia), Spain. FAU - Diez-Domingo, Javier AU - Diez-Domingo J AD - Area de Investigacion en Vacunas, FISABIO - Salud Publica, Valencia, Spain. Electronic address: Javier.diez@fisabio.es. LA - eng PT - Journal Article DEP - 20221128 PL - Spain TA - Enferm Infecc Microbiol Clin (Engl Ed) JT - Enfermedades infecciosas y microbiologia clinica (English ed.) JID - 101777541 SB - IM OTO - NOTNLM OT - Adverse drug events OT - Adverse drug reaction reporting systems OT - Drug safety OT - Efectos adversos de los medicamentos OT - Farmacoepidemiologia OT - Flu vaccines OT - Pharmacoepidemiology OT - Seguridad de los medicamentos OT - Sistemas de notificacion de reacciones adversas a los medicamentos OT - Vaccination OT - Vacunacion OT - Vacunas contra la gripe EDAT- 2022/12/02 06:00 MHDA- 2022/12/02 06:01 CRDT- 2022/12/01 22:08 PHST- 2021/11/09 00:00 [received] PHST- 2022/02/03 00:00 [revised] PHST- 2022/02/10 00:00 [accepted] PHST- 2022/12/02 06:01 [medline] PHST- 2022/12/02 06:00 [pubmed] PHST- 2022/12/01 22:08 [entrez] AID - S2529-993X(22)00254-4 [pii] AID - 10.1016/j.eimce.2022.11.005 [doi] PST - ppublish SO - Enferm Infecc Microbiol Clin (Engl Ed). 2023 Aug-Sep;41(7):420-422. doi: 10.1016/j.eimce.2022.11.005. Epub 2022 Nov 28.