Title : Maternal, fetal and neonatal outcomes for women exposure during pregnancy to COVID-19 vaccines
Although the European Medicines Agency (EMA) encourages coronavirus disease 2019 (COVID-19) vaccination in pregnant women, the scientific evidence supporting the use of COVID-19 vaccines during pregnancy is still limited. Thus, we investigated adverse events following immunization (AEFI) with COVID-19 vaccines during pregnancy.
For this aim, we retrieved Individual Case Safety Reports (ICSRs) related to the use of COVID-19 vaccines during pregnancy from the European Pharmacovigilance (EudraVigilance) for the year 2021. We analyzed AEFI related to both the mother and fetus/newborn and we computed the reporting odds ratio (ROR) in order to compare the reporting probability of spontaneous abortion between COVID-19 vaccines. During the study period, among 1,315,315 ICSRs related to COVID-19 vaccines, we retrieved 3,252 (0.25%) reports related to their use in pregnancy. More than half (58.24%) of ICSRs were submitted by non-healthcare professionals. Although the majority (87.82%) of ICSRs concerned serious AEFI, their outcomes were mostly favorable. In this study, 85.0% of total ICSRs referred to pregnant women (n = 2,764), while 7.9% referred to fetuses/newborns (n = 258). We identified 16,569 AEFI. Moreover, 55.16% were AEFI not related to pregnancy (mostly headache, pyrexia, and fatigue), while 17.92% were pregnancy-, newborn-, or fetus-related AEFI. Among pregnancy related AEFI, the most reported was spontaneous abortion. Messenger RNA (mRNA) vaccines had a lower reporting probability of spontaneous abortion than viral vector-based vaccines (ROR 0.80, 95% CI 0.69-0.93). Moderna and Oxford-AstraZeneca vaccines had a higher reporting probability of spontaneous abortion (ROR 1.2, 95% CI 1.05-1.38 and ROR 1.26, 95% CI 1.08-1.47, respectively), while a lower reporting probability was found for Pfizer-BioNTech vaccine compared with all other COVID-19 vaccines (ROR 0.73, 95% CI 0.64-0.84). In addition, 5.8% of ICSRs reported a fatal outcome. At the light of these results, no strong insight into unknown AEFI associated with COVID-19 vaccination in pregnant women was observed. Considering the high risk associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, our analysis suggests that the benefits of COVID-19 vaccines during pregnancy outweigh the possible risks. However, it is important to continue monitoring the safety profile of COVID-19 vaccines in this subpopulation.
Audience Take Away Notes:
- None of the COVID-19 vaccines approved under the conditional marketing authorization was tested in pregnant women during the initial trials.
- Observational data from pregnant women vaccinated with COVID-19 vaccines did not show an increase in adverse pregnancy outcomes.
- Given the poor attitude of healthcare professionals in encouraging vaccination during pregnancy, the results of this analysis could make aware them of the safety profile of Covid-19 vaccines and reduce the amount of anxiety and concern of pregnant women to get vaccinated.