Your browser doesn't support javascript.
Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study.
Mascolo, Annamaria; di Mauro, Gabriella; Fraenza, Federica; Gaio, Mario; Zinzi, Alessia; Pentella, Ciro; Rossi, Francesco; Capuano, Annalisa; Sportiello, Liberata.
  • Mascolo A; Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Naples, Italy.
  • di Mauro G; Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
  • Fraenza F; Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Naples, Italy.
  • Gaio M; Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
  • Zinzi A; UOC Pharmacy, AORN Santobono-Pausilipon Children's Hospital, Naples, Italy.
  • Pentella C; Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Naples, Italy.
  • Rossi F; Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
  • Capuano A; Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Naples, Italy.
  • Sportiello L; Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
Front Immunol ; 13: 965171, 2022.
Article in English | MEDLINE | ID: covidwho-2080143
ABSTRACT

Introduction:

Although the European Medicines Agency (EMA) encourage coronavirus disease 2019 (COVID-19) vaccination in pregnant women, the scientific evidence supporting the use of COVID-19 vaccines during pregnancy is still limited.

Aim:

We aimed to investigate adverse events following immunization (AEFI) with COVID-19 vaccines during pregnancy.

Methods:

We retrieved Individual Case Safety Reports (ICSRs) related to the use of COVID-19 vaccines during pregnancy from the EudraVigilance database for the year 2021. We analyzed AEFI related to the mother and fetus/newborn. The reporting odds ratio (ROR) was computed to compare the reporting probability of spontaneous abortion between COVID-19 vaccines.

Results:

During the study period, among 1,315,315 ICSRs related to COVID-19 vaccines, we retrieved 3,252 (0.25%) reports related to the 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.

Conclusions:

No strong insight of 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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Abortion, Spontaneous / COVID-19 Vaccines / COVID-19 Type of study: Observational study / Prognostic study Topics: Vaccines Limits: Female / Humans / Infant, Newborn / Pregnancy Language: English Journal: Front Immunol Year: 2022 Document Type: Article Affiliation country: Fimmu.2022.965171

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: Abortion, Spontaneous / COVID-19 Vaccines / COVID-19 Type of study: Observational study / Prognostic study Topics: Vaccines Limits: Female / Humans / Infant, Newborn / Pregnancy Language: English Journal: Front Immunol Year: 2022 Document Type: Article Affiliation country: Fimmu.2022.965171