P.020 The North American AED Pregnancy Registry: A Canadian Subgroup Analysis (1997-2019)

Background: This study aims to provide data on the care of pregnant women with epilepsy (pWWE) that is directly applicable to the Canadian context. Methods: Between 1997 and 2019, pWWE from Canada and the USA who enrolled into the North American AED Pregnancy Registry (NAARP) completed a questionnaire on their AED (anti-epileptic drug) usage. Enrollment rates to NAARP were compared between the two countries, and between the different Canadian provinces using population-based enrollment rate ratios (PERR). The AED prescription pattern among Canadian pWWE was analysed and compared with the USA. Results: During the study period, 10,215 women enrolled into NAARP : 4.1% (n=419) were Canadian, below the expected population-based contribution (PERR=0.42; p<0.01). Within Canada, the three northern territories (PERR=0; p<0.01), Prince-Edward Island (PERR=0; p<0.01), and Quebec (PERR=0.41; p<0.01) had the lowest enrollment rate ratios. Lamotrigine was the most commonly prescribed AED among canadian pWWE; they were, however, more likely to be on polytherapy (25%; p=0.13), on Carbamazepine (24%; p<0.01) or valproic acid (21%; p<0.01) than their American counterparts. Conclusions: Greater enrollment of Canadian women to NAARP, through enhanced clinician referrals, in particular from underrepresented provinces/territories, could lead to more accurate population-specific data and help identify gaps in the care of this vulnerable patient population.

Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020-21

Background There is continuing public concern about the safety of COVID-19 vaccination during pregnancy. While there is no compelling biological reason to expect that mRNA COVID-19 vaccination (either preconception or during pregnancy) presents a risk to pregnancy, data are limited. It is, however, well documented that SARS-CoV-2 infection during pregnancy is associated with severe illness and increased risk of adverse pregnancy outcomes. Among recognized pregnancies in high-income countries, 11–16% end in spontaneous abortion (SAB). Methods People enrolled in v-safe, a voluntary smartphone-based surveillance system, who received a COVID-19 vaccine preconception or during pregnancy were contacted by telephone to enroll in the v-safe pregnancy registry. V-safe pregnancy registry participants who received at least one dose of an mRNA COVID-19 vaccine preconception or prior to 20 weeks’ gestation and who did not report a pregnancy loss before 6 completed weeks’ gestation were included in this analysis to assess the cumulative risk of SAB using Life Table methods. Results Among 2,456 pregnant persons who received an mRNA COVID-19 vaccine preconception or prior to 20 weeks’ gestation, the cumulative risk of SAB from 6–19 weeks’ gestation was 14.1% (95% CI: 12.1, 16.1%). Using direct age standardization to the selected reference population, the age-standardized cumulative risk of SAB was 12.8% (95% CI: 10.8–14.8%). Conclusions When compared to the expected range of SABs in recognized pregnancies, these data suggest receipt of an mRNA COVID-19 vaccine preconception or during pregnancy is not associated with an increased risk of SAB. These findings add to accumulating evidence that mRNA COVID-19 vaccines during pregnancy are safe.

Data of the COVID-19 mRNA-Vaccine V-Safe Surveillance System and Pregnancy Registry Reveals Poor Embryonic and Second Trimester Fetal Survival Rate. Comment on Stuckelberger et al. SARS-CoV-2 Vaccine Willingness among Pregnant and Breastfeeding Women during the First Pandemic Wave: A Cross-Sectional Study in Switzerland. Viruses 2021, 13, 1199

Dr. Sarah Stuckelberger and her colleagues should be commended for their cross-sectional study assessing the willingness of Swiss pregnant and breastfeeding women to be vaccinated against SARS-CoV-2 [...]

Current Data on COVID-19 mRNA-Vaccine Safety during Pregnancy Might Be Subject to Selection Bias. Reply to Stroobandt, S.; Stroobandt, R. Data of the COVID-19 mRNA-Vaccine V-Safe Surveillance System and Pregnancy Registry Reveals Poor Embryonic and Second Trimester Fetal Survival Rate. Comment on “Stuckelberger et al. SARS-CoV-2 Vaccine Willingness among Pregnant and Breastfeeding Women during the First Pandemic Wave: A Cross-Sectional Study in Switzerland. Viruses 2021, 13, 1199”

We would like to thank Stroobandt, S. and Stroobandt, R. for showing interest in our paper [...]