COVID-19 mRNA vaccine in pregnancy: Results of the Swiss COVI-PREG registry, an observational prospective cohort study

doi:10.1016/j.lanepe.2022.100410

. 2022 May 29:18:100410.

doi: 10.1016/j.lanepe.2022.100410. eCollection 2022 Jul.

COVID-19 mRNA vaccine in pregnancy: Results of the Swiss COVI-PREG registry, an observational prospective cohort study

Guillaume Favre¹, Emeline Maisonneuve², Léo Pomar^{1

3}, Ursula Winterfeld⁴, Charlotte Daire¹, Begoña Martinez de Tejada^{5

6}, Dominique Delecraz⁷, Sonia Campelo⁷, Mirjam Moser⁸, Monya Todesco-Bernasconi⁸, Stefanie Sturm⁹, Irene Hösli¹⁰, Cécile Monod¹⁰, Brigitte Frey Tirri¹¹, Stylianos Kalimeris¹², Carolin Blume¹², Jérôme Mathis^{13

14}, Roland Zimmerman¹⁵, Anda Petronela Radan¹⁴, Daniel Surbek¹⁴, David Baud¹, Alice Panchaud^{1

2

16}

Affiliations

¹ Materno-fetal and Obstetrics Research Unit, Department "Femme-Mère-Enfant", University Hospital, Lausanne, Switzerland.
² Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.
³ School of Health Sciences (HESAV), University of Applied Sciences and Arts Western Switzerland, Lausanne, Switzerland.
⁴ Swiss Teratogen Information Service, Clinical pharmacology unit, Lausanne University Hospital and University of Lausanne, Switzerland.
⁵ Obstetrics Division, Department of Pediatrics, Gynecology, and Obstetrics Geneva University Hospitals, Geneva, Switzerland.
⁶ Faculty of Medicine, University of Geneva, Switzerland.
⁷ Research Platform, Department of Pediatrics, Gynecology, and Obstetrics, Faculty of Medicine, University of Geneva, Switzerland.
⁸ Department of Obstetrics and Gynecology, Cantonal Hospital Aarau, Aarau, Switzerland.
⁹ Frauenpraxis, Schaffhausen, Switzerland.
¹⁰ Department of Obstetrics and Gynecology, University Hospital Basel, Basel, Switzerland.
¹¹ Department of Gynecology and Obstetrics, Cantonal Hospital Baselland, Liestal, Switzerland.
¹² Department of Obstetrics and Gynecology, Cantonal Hospital Graubünden, Chur, Switzerland.
¹³ Obstetrics and Gynecology Unit, Biel Hospital, Biel, Switzerland.
¹⁴ Department of Obstetrics and Feto-maternal Medicine, University Hospital of Bern, Switzerland.
¹⁵ Department of Obstetrics, University Hospital of Zurich, Zurich, Switzerland.
¹⁶ Service of Pharmacy, Lausanne University Hospital and University of Lausanne, Switzerland.

PMID: 35651954
PMCID: PMC9148537
DOI: 10.1016/j.lanepe.2022.100410

COVID-19 mRNA vaccine in pregnancy: Results of the Swiss COVI-PREG registry, an observational prospective cohort study

Guillaume Favre et al. Lancet Reg Health Eur. 2022.

. 2022 May 29:18:100410.

doi: 10.1016/j.lanepe.2022.100410. eCollection 2022 Jul.

Authors

Affiliations

¹ Materno-fetal and Obstetrics Research Unit, Department "Femme-Mère-Enfant", University Hospital, Lausanne, Switzerland.
² Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.
³ School of Health Sciences (HESAV), University of Applied Sciences and Arts Western Switzerland, Lausanne, Switzerland.
⁴ Swiss Teratogen Information Service, Clinical pharmacology unit, Lausanne University Hospital and University of Lausanne, Switzerland.
⁵ Obstetrics Division, Department of Pediatrics, Gynecology, and Obstetrics Geneva University Hospitals, Geneva, Switzerland.
⁶ Faculty of Medicine, University of Geneva, Switzerland.
⁷ Research Platform, Department of Pediatrics, Gynecology, and Obstetrics, Faculty of Medicine, University of Geneva, Switzerland.
⁸ Department of Obstetrics and Gynecology, Cantonal Hospital Aarau, Aarau, Switzerland.
⁹ Frauenpraxis, Schaffhausen, Switzerland.
¹⁰ Department of Obstetrics and Gynecology, University Hospital Basel, Basel, Switzerland.
¹¹ Department of Gynecology and Obstetrics, Cantonal Hospital Baselland, Liestal, Switzerland.
¹² Department of Obstetrics and Gynecology, Cantonal Hospital Graubünden, Chur, Switzerland.
¹³ Obstetrics and Gynecology Unit, Biel Hospital, Biel, Switzerland.
¹⁴ Department of Obstetrics and Feto-maternal Medicine, University Hospital of Bern, Switzerland.
¹⁵ Department of Obstetrics, University Hospital of Zurich, Zurich, Switzerland.
¹⁶ Service of Pharmacy, Lausanne University Hospital and University of Lausanne, Switzerland.

PMID: 35651954
PMCID: PMC9148537
DOI: 10.1016/j.lanepe.2022.100410

Abstract

Background: Pregnant individuals with coronavirus disease 2019 (COVID-19) are at increased risk of severe disease, prematurity, and stillbirth. In March 2021, vaccination for at risk pregnant women was recommended in Switzerland, expanding this to all pregnant women in May 2021. Our aim was to assess the safety of mRNA COVID-19 vaccines in pregnancy.

Methods: This multicentre prospective cohort study describes early adverse events and perinatal outcomes in pregnant women who received at least one dose of mRNA vaccine between March 1st and December 27th, 2021 in Switzerland, using the COVI-PREG registry. Early adverse events were collected at least one month following vaccine administration. Pregnancy and neonatal outcomes were extracted from medical records using the maternity discharge letters providing follow-up information up to 5 days after birth.

Findings: Of 1012 vaccinated women, 894 (88·3%) received both injections during pregnancy, with BNT162b2 (n = 271) or mRNA-1273 (n = 623) vaccines. Local events (mainly local pain) were reported in 81·3% and 80·5% after the first and second doses. Rates of systemic reactions (mainly fatigue and headache) were similar after the first dose and most frequent after the second dose of mRNA-1273. Of the 1012 women, four (0·4%; 95%CI [0·1-1·0]) severe early adverse events occurred: pulmonary embolism, preterm premature rupture of membranes, isolated fever with hospitalisation, and herpes zoster. Of 107 patients vaccinated before 14 weeks, one (0·9%; 95%CI [0·0-5·1]) early spontaneous abortions was reported (8 weeks). Of 228 vaccinated before 20 weeks one (0·4%; 95%CI [0·0-2·4]) late spontaneous abortion was reported (16 weeks). Of 513 women exposed before 37 weeks, 33 (6·4%; 95%CI [4·5-8·9]) delivered preterm. Among 530 patients exposed in pregnancy, no stillbirth was reported and 25 (4·7%; 95%CI [3·0-6·8]) neonates were admitted to intensive care unit.

Interpretation: Frequent local and systemic effects were described after exposure to mRNA COVID-19 vaccines during pregnancy but severe events were rare. Women vaccinated during pregnancy did not experience higher adverse pregnancy or neonatal outcomes when compared to historical data on background risks in the obstetric population.

Funding: This research was funded by a grant from the Swiss Federal Office of Public Health and the CHUV Foundation.

Keywords: COVID-19; Pregnancy; Pregnant women; SARS-CoV-2; Safety; Vaccine; mRNA.

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Conflict of interest statement

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf. Alice Panchaud received grants from the Swiss Federal Office of Public Health and the CHUV Foundation; she also received grants from Vifor, the European Medicine Agency (EMA/2017/09/PE and EMA/2017/09/PE/11), the Fonds Paritaire RBP IV and a H2020 grant (ConcePTION WP 3-4), outside the submitted work. Begoña Martinez de Tejada reported receiving financial support from the General Health Division in Geneva, Switzerland, and being a medical advisor for Effik consulting fees and lectures) and Pierre Fabre (consulting fees), outside the submitted work; she also reported having a research agreement for clinical devices with Pregnolia and having been paid as a legal expert in a malpractice case, outside the submitted work. All other authors declare no conflicts of interest

Figures

Fig 1 — **Figure 1**
Flow chart of the study. The numbers of patients eligible for each analysis are displayed (Study populations 1a to 2d). Abbreviation: LMP: last menstrual period; PCP: peri-conceptional period; SP.: spontaneous; wks: weeks of gestation.

Fig 2 — **Figure 2**
Local and systemic reactions reported within one month after each injection of mRNA COVID-19 vaccines in pregnancy. Proportions (%) are displayed and I bars represent 95% confidence intervals.

See this image and copyright information in PMC

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References

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[1] Lokken EM, Taylor GG, Huebner EM, et al. Higher severe acute respiratory syndrome coronavirus 2 infection rate in pregnant patients. Am J Obstet Gynecol. 2021;225(1) 75.e1-75.e16. - PMC - PubMed

[2] Lokken EM, Taylor GG, Huebner EM, et al. Higher severe acute respiratory syndrome coronavirus 2 infection rate in pregnant patients. Am J Obstet Gynecol. 2021;225(1) 75.e1-75.e16. - PMC - PubMed

[3] Vouga M, Favre G, Martinez-Perez O, et al. Maternal outcomes and risk factors for COVID-19 severity among pregnant women. Sci Rep. 2021;11(1):13898. - PMC - PubMed

[4] Vouga M, Favre G, Martinez-Perez O, et al. Maternal outcomes and risk factors for COVID-19 severity among pregnant women. Sci Rep. 2021;11(1):13898. - PMC - PubMed

[5] Allotey J, Stallings E, Bonet M, et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020;370:m3320. - PMC - PubMed

[6] Allotey J, Stallings E, Bonet M, et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020;370:m3320. - PMC - PubMed

[7] DeSisto CL, Wallace B, Simeone RM, et al. Risk for stillbirth among women with and without COVID-19 at delivery hospitalization - United States, March 2020-September 2021. MMWR Morb Mortal Wkly Rep. 2021;70(47):1640–1645. - PMC - PubMed

[8] DeSisto CL, Wallace B, Simeone RM, et al. Risk for stillbirth among women with and without COVID-19 at delivery hospitalization - United States, March 2020-September 2021. MMWR Morb Mortal Wkly Rep. 2021;70(47):1640–1645. - PMC - PubMed

[9] Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603–2615. - PMC - PubMed

[10] Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603–2615. - PMC - PubMed

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COVID-19 mRNA vaccine in pregnancy: Results of the Swiss COVI-PREG registry, an observational prospective cohort study

Affiliations

COVID-19 mRNA vaccine in pregnancy: Results of the Swiss COVI-PREG registry, an observational prospective cohort study

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