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COVACPREG, a French prospective cohort study of women vaccinated against COVID-19 during pregnancy - 12/07/24

Doi : 10.1016/j.therap.2024.06.003 
Isabelle Lacroix a, Anthony Caillet a, Laurane Delteil a, Hadjer Ameur b, Nassima Padelli a, Caroline Hurault-Delarue a, Judith Cottin b,
a Service de pharmacologie médicale et clinique, Centre de pharmacovigilance, de pharmacoépidémiologie et d’informations sur le médicament (CRPV), faculté de médecine, CHU de Toulouse, 31000 Toulouse, France 
b Service hospitalo-universitaire de pharmacotoxicologie, centre régional de pharmacovigilance, hospices civils de Lyon, 162, avenue Lacassagne, 69424 Lyon cedex 03, France 

Corresponding author. Service de pharmacologie médicale et clinique, Centre de pharmacovigilance, de pharmacoépidémiologie et d’informations sur le médicament (CRPV), faculté de médecine, CHU de Toulouse, 37, allées Jules-Guesde, 31000 Toulouse, France.Service de pharmacologie médicale et clinique, Centre de pharmacovigilance, de pharmacoépidémiologie et d’informations sur le médicament (CRPV), faculté de médecine, CHU de Toulouse37, allées Jules-GuesdeToulouse31000France

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Summary

The objective of this cohort study was to describe the French population of pregnant women vaccinated against coronavirus disease 2019 (COVID-19), their pregnancy outcomes and the health status of their newborns (malformation rate, neonatal diseases, etc.), and to proactively collect and analyze reported adverse reactions over time. We conducted a prospective study using an online questionnaire. Women vaccinated during pregnancy who wanted to participate were asked to complete an inclusion questionnaire (dates of pregnancy and vaccination COVID-19, etc.), a questionnaire on the potential occurrence of adverse reactions (time of onset, type of adverse reaction, etc.) of the vaccination, sent 1 month after the injection, and a final questionnaire on the outcome of the pregnancy and the health status of the child. A total of 938 women were prospectively included in this first French study. A total of 132 women reported having had at least 1 adverse reaction following vaccination during pregnancy (14.1%), including few ‘serious’ adverse reaction (5.3%). There were no signals of adverse reactions during continuous monitoring. Among the 938 pregnant women, 22.4% received the vaccination COVID-19 during the first trimester, 64.2% during the second and 33.4% during the third trimester (some women have had several injections in different trimesters). Among the 938 women, 4.3% developed gestational hypertension and 13.9% diabetes; 3.3% had intrauterine growth restriction and 7.8% threatened preterm delivery. These rates are comparable to those observed in the French general population. Among live births, the rate of preterm birth was 5.1%. We reported a prevalence of major malformations of 3.9%, which is comparable to that reported by European Surveillance of Congenital Anomalies (EUROCAT), with a rate of 3.5% of major malformations in the general population of mainland France. In conclusion, our study did not demonstrate any particular safety signals in the event of vaccination with a Covid-19 vaccine during pregnancy.

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Keywords : Cohort study, COVID-19 vaccine, Pregnancy, Congenital anomalies, Pregnancy termination


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© 2024  Société française de pharmacologie et de thérapeutique. Publicado por Elsevier Masson SAS. Todos los derechos reservados.
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