Adverse events in pregnant women with the tetravalent influenza vaccine obtained from cell cultures

Juan José Carreras; José Antonio Lluch; José Antonio Taboada; Eliseo Pastor-Villalba; Victoria Nartallo-Penas; Javier Díez-Domingo

doi:10.1016/j.eimce.2022.11.005

Adverse events in pregnant women with the tetravalent influenza vaccine obtained from cell cultures

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.

Authors

Juan José Carreras¹, José Antonio Lluch², José Antonio Taboada³, Eliseo Pastor-Villalba², Victoria Nartallo-Penas³, Javier Díez-Domingo⁴

Affiliations

¹ Área de Investigación en Vacunas, FISABIO - Salud Pública, Valencia, Spain.
² Dirección General de Salud Pública y Adicciones, Conselleria de Sanitat Universal i Salut Pública, Valencia (Comunidad Valenciana), Spain.
³ Programa Galego de Vacinación, Dirección Xeral de Saúde Pública, Consellería de Sanidade, Santiago de Compostela (Galicia), Spain.
⁴ Área de Investigación en Vacunas, FISABIO - Salud Pública, Valencia, Spain. Electronic address: Javier.diez@fisabio.es.

PMID: 36456431
DOI: 10.1016/j.eimce.2022.11.005

Abstract

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.

Keywords: Adverse drug events; Adverse drug reaction reporting systems; Drug safety; Efectos adversos de los medicamentos; Farmacoepidemiología; Flu vaccines; Pharmacoepidemiology; Seguridad de los medicamentos; Sistemas de notificación de reacciones adversas a los medicamentos; Vaccination; Vacunación; Vacunas contra la gripe.