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

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.