key: cord-0891393-vssu09ps
authors: Cottin, Judith; Benevent, Justine; Khettar, Sophie; Lacroix, Isabelle
title: COVID-19 vaccines and pregnancy: what do we know?
date: 2021-06-01
journal: Therapie
DOI: 10.1016/j.therap.2021.05.011
sha: ab1bdd8ae14e54851a2687b481eb233197cbc82d
doc_id: 891393
cord_uid: vssu09ps

nan

pregnancies resulted in a live birth in 712 cases (86.1%), in spontaneous abortion in 104 cases (12.6%), in stillbirth in one case (0.1%) and in other outcomes (induced abortion and ectopic pregnancy) in 10 cases (1.2%). Among 724 live-born infants, including 12 sets of multiple gestation, 9.4% were born preterm (60 of 636 among those vaccinated before 37 weeks), 3.2% had a small size for gestational age and 2.2% major congenital anomalies; no neonatal deaths were reported at the time of interview. These incidences of spontaneous miscarriage, pregnancy complications, prematurity and birth defects were comparable to those expected in the general population.

Preliminary American data [9] demonstrated transmission of maternal antibodies to the foetus via the placenta, although it is too early to conclude that this will protect future newborns.

The mode of action of non-live vaccines makes a risk of malformation unlikely. Data on other non-live vaccines, such as that for influenza, are reassuring [10] . Based on what is known about how mRNA vaccines act locally (at the site of injection) and are rapidly degraded and removed by the lymphatic system, the likelihood of the vaccine reaching and crossing the placenta is believed to be low.

In view of this data, vaccination can be considered for pregnant women from the 2 nd trimester (period carrying a lower risk of teratogenic effects and pregnancy termination), Primary online enrolment will be carried out at the time of vaccination at the main vaccination sites, with the pregnant woman's consent. Information will be collected on her medical history, history of COVID-19, her pregnancy (dates of conception and expected deliver) and other possible medicinal or non-medicinal exposures since the start of pregnancy. One month after each injection of the vaccine, information will be collected on any vaccination-related adverse reactions (fever, hypertension, etc.). Finally, in the 2 months following the expected delivery date, information will be collected on the outcome of the pregnancy (delivery, spontaneous abortion, etc.), the new-born infant (term, weight, malformations, neonatal clinical signs) and maternal clinical signs (preeclampsia, gestational hypertension, gestational diabetes, etc.). We have planned to include nearly 5,000 vaccinated pregnant women in this study. Final results are expected by the end of 2022 but reported adverse drug reactions will be continuously analysed (alert system) and an interim analysis will be carried out in the middle of the study.

The authors declare that they have no competing interest

Guidelines for pregnant women with suspected SARS-CoV-2 infection

Maternal and neonatal morbidity and mortality among pregnant women with and without COVID-19 infection: The INTERCOVID Multinational Cohort Study

Effects of the COVID-19 pandemic on maternal and perinatal outcomes: a systematic review and meta-analysis

Clinical findings and disease severity in hospitalized pregnant women

Transplacental transmission of SARS-CoV-2 infection

Common name: COVID-19 mRNA vaccine (nucleoside-modified)

Summary of product characteristics

Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons

COVID-19 vaccine response in pregnant and lactating women: a cohort study

The effects of influenza vaccination during pregnancy on birth outcomes: a systematic review and meta-analysis