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. 2025 Apr 29;85(10):1090-1102.
doi: 10.1055/a-2576-6293. eCollection 2025 Oct.

Vaccine Effectiveness in SARS-CoV-2-Infected Pregnant Women with Gestational Diabetes Mellitus: Results from a Multicenter Registry-Based Prospective Cohort Study in Germany

Eike A Strathmann  1 , Katharina S Weber  1 , Babett Ramsauer  2 , Dietmar Schlembach  2 , Janine Zöllkau  3 , Ute M Schaefer-Graf  4 , Sophia Ajouby  5 , Kristin Andresen  6 , Michael K Bohlmann  7 , Iris Dressler-Steinbach  8 , Antonella Iannaccone  9 , Peter Jakubowski  10 , Mirjam Kunze  11 , Bettina Kuschel  12 , Nadine Mand  13 , Mandy Mangler  14 , Valerie Meister  15 , Kathleen M Oberste  16 , Katharina Rathberger  17 , Kristin Reinhardt  18 , Lydia Remtisch  19 , Linda Wegner  20 , Katharina Weizsäcker  8 , Feline Wowretzko  21 , Mario Rüdiger  22 , Ulrich Pecks  23   24 , Helmut J Kleinwechter  25 ; COVID-19-Related Obstetric and Neonatal Outcome Study (CRONOS) Network
Affiliations

Vaccine Effectiveness in SARS-CoV-2-Infected Pregnant Women with Gestational Diabetes Mellitus: Results from a Multicenter Registry-Based Prospective Cohort Study in Germany

Eike A Strathmann et al. Geburtshilfe Frauenheilkd. .

Abstract
in English, German

Introduction COVID-19 in pregnancy is associated with increased maternal and neonatal morbidity and mortality. The aim of our study was to investigate the effectiveness of COVID-19 vaccination in SARS-CoV-2-infected pregnant women with focus on women with gestational diabetes mellitus on pregnancy outcomes. Patients and Methods COVID-19 Obstetric and Neonatal Outcome study is a multicenter prospective observational study which registered SARS-CoV-2-infected pregnant women from April 2020 to December 2022. In March 2021, the study was complemented by the SATELLITES study which recruited vaccinated women until September 2023. Primary composite maternal and neonatal endpoints were defined. Multivariate adjusted logistic regression analysis was performed to evaluate the impact of vaccination on pregnancy outcomes. Vaccine effectiveness was defined as (1-adjusted odds ratio)*100. Results We registered 10 386 pregnant women, 6112 of whom were analyzed. 30% of women were vaccinated against COVID-19. Vaccination in women with gestational diabetes mellitus was associated with a vaccine effectiveness of 75% (95% CI: 16 - 93), depending on the predominant virus variant, and of 67% in the total cohort (95% CI: 36 - 83). No statistically significant difference was found in vaccine effectiveness with regards to perinatal outcomes of women with gestational diabetes mellitus (16%; 95% CI -58 - 55) but there was an impact in the total cohort (26%; 95% CI 8 - 94). Conclusion For pregnant women with gestational diabetes mellitus who were infected with SARS-CoV-2, at least one vaccination against COVID-19 before or during pregnancy was independently associated with a milder course of COVID-19 in mothers compared to no vaccination. We found no evidence of improved perinatal outcomes. The data emphasize the benefits of vaccination before or during pregnancy.

Einleitung Eine COVID-19-Erkrankung in der Schwangerschaft ist mit höherer mütterlicher und fetaler Morbidität und Mortalität verbunden. Ziel dieser Studie war es, die Wirksamkeit einer COVID-19-Impfung bei mit SARS-CoV-2 infizierten schwangeren Frauen zu untersuchen mit besonderem Augenmerk auf die Schwangerschaft-Outcomes von Frauen mit Gestationsdiabetes. Patientinnen und Methoden Die COVID-19 Obstetric and Neonatal Outcome Studie ist eine multizentrische prospektive Beobachtungsstudie, die von April 2020 bis Dezember 2022 mit COVID-19 infizierte schwangere Frauen registrierte. Im März 2021 wurde die Studie durch die SATELLITES-Studie ergänzt, die geimpfte Frauen bis September 2023 rekrutierte. Die primären zusammengefassten mütterlichen und neonatalen Endpunkten wurden definiert. Es wurde eine multivariate logistische Regressionsanalyse durchgeführt, um die Auswirkungen von Impfungen auf das Schwangerschafts-Outcome zu evaluieren. Die Imfpstoffwirksamkeit wurde als (1-adjusted Odds Ratio)*100 definiert. Ergebnisse Insgesamt wurden 10 386 schwangere Frauen registriert, davon wurden 6112 in die Analyse eingeschlossen; 30% der Frauen waren gegen COVID-19 geimpft. Je nach vorherrschender Virusvariante betrug die Impfstoffwirksamkeit hinsichtlich des zusammengefassten mütterlichen Endpunkts 75% (95%-KI 16 – 93) bei Frauen mit Gestationsdiabetes und 67% (95%-KI 36 – 83) für die Gesamtkohorte. Hinsichtlich des perinatalen Outcomes gab es keinen statistisch signifikanten Unterschied zwischen geimpften und ungeimpften Frauen mit Gestationsdiabetes (16%; 95%-KI −58 – 55), wohl aber in der Gesamtkohorte (26%; 95%-KI 8 – 94). Schlussfolgerung Bei schwangeren Frauen mit Gestationsdiabetes, die mit SARS-CoV-2 infiziert wurden, zeigte sich, dass mindestens eine Impfung gegen COVID-19 vor oder während der Schwangerschaft mit einem milderen Verlauf der COVID-19 Erkrankung assoziiert war, verglichen mit Frauen, die keine Impfung erhalten hatten. Es gab keine Hinweise auf ein besseres perinatales Outcome. Diese Daten unterstreichen die Vorteile einer Impfung vor oder während der Schwangerschaft.

Keywords: SARS-CoV-2; diabetes; impaired glucose tolerance; pregnancy; vaccination.

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Conflict of interest statement

Conflict of Interest The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Flowchart showing the CRONOS and SATELLITES participants eligible for analysis. CRONOS, COVID-19-Related Obstetric and Neonatal Outcome Study; GDM, gestational diabetes mellitus.
Fig. 2
Fig. 2
Associations between vaccination status and primary composite endpoints. Odds ratios with 95% CI for the composite maternal endpoint in the GDM ( a ) and the total cohort ( b ): (1) admission to intensive care unit (including invasive ventilation and death), (2) need for oxygen supplementation outside intensive care unit and the composite neonatal endpoint in the GDM ( c ) and the total cohort ( d ): (1) stillbirth ≥ 24 0/7 weeks of pregnancy, (2) neonatal death ≤ 7 days postnatally, (3) transfer to neonatal intensive care unit, (4) preterm birth < 37 0/7 weeks of gestation. Model 1 adjusted for maternal age (years) and the BMI category (< 25 kg/m 2 />25 kg/m 2 ). Model 2 additionally adjusted for multiple birth (yes, no), parity (nulliparous, multiparous), and hypertensive medication (yes, no). Model 3 additionally adjusted for language competence (yes, no) and nicotine exposure during pregnancy (yes, no). Model 4 additionally adjusted for virus variant (pre-Omicron, Omicron). Model 5 in the GDM cohort additionally adjusted for insulin therapy (yes, no). GDM, gestational diabetes mellitus; VE, vaccination effectiveness.
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