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Speaker at Drug Delivery Events - Liberata Sportiello
University of Campania “L. Vanvitelli”, Italy
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.


Liberata Sportiello graduated in Pharmaceutical Chemistry and Technologies in 2006 and specialized in Hospital Pharmacy in 2009 at the “Federico II” University in Naples (Italy). Successively, she joined the research group of Prof. Annalisa Capuano at the University of Campania “L. Vanvitelli” in Naples, where she obtained a permanent contract for an academic position in 2011 and her PhD degree in Pharmacology in 2013. She gained a long research experience in pharmacovigilance and pharmacoepidemiology, focusing on the analysis of databases related to the safety profile of drugs and vaccines. She has published more than 60 articles in peer-reviewed international scientific journals.