Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022 : a multinational, observational study

Article Article scientifique Article Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022 : a multinational, observational study eng 2023-01-17 2023-02-11 author Villar Jose Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK; Oxford Maternal and Perinatal Health Institute, Green Templeton College, University of Oxford, Oxford, UK. author Soto Conti Constanza P Division Neonatología, Hospital Materno Infantil Ramón Sarda, Buenos Aires, Argentina. author Gunier Robert B Center for Environmental Research and Community Health (CERCH), School of Public Health, University of California, Berkeley, CA, USA. author Ariff Shabina Department of Paediatrics and Child Health, The Aga Khan University Hospital, Karachi, Pakistan. author Craik Rachel Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK. author Cavoretto Paolo I 0000-0001-8097-366X Vita-Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Obstetrics and Gynaecology Department, Milan, Italy. author Rauch Stephen Center for Environmental Research and Community Health (CERCH), School of Public Health, University of California, Berkeley, CA, USA. author Gandino Serena 0000-0003-1461-5527 Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK. author Nieto Ricardo Division Neonatología, Hospital Materno Infantil Ramón Sarda, Buenos Aires, Argentina. author Winsey Adele Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK. author Menis Camilla Department of Clinical Sciences and Community Health, University of Milan, NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. author Rodriguez Gabriel B Oxford Maternal and Perinatal Health Institute, Green Templeton College, University of Oxford, Oxford, UK. author Savasi Valeria Unit of Obstetrics and Gynecology, L- Sacco Hospital ASST Fatebenefratelli Sacco, Department of Biological and Clinical Sciences, University of Milan, Milan, Italy. author Tug Niyazi Department of Obstetrics and Gynecology, Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital, University of Health Sciences, Istanbul, Türkiye. author Deantoni Sonia 0000-0002-8072-2593 Neonatal Care Unit, Department of Public Health and Pediatrics, School of Medicine, University of Turin, Turin, Italy. author Fabre Marta Instituto de Investigación Sanitario de Aragón (IIS Aragon), Hospital Clínico Universitario Lozano Blesa Zaragoza, Zaragoza, Spain. author Martinez De Tejada Weber Begona Department of Pediatrics, Gynecology & Obstetrics, Hôpitaux Universitaires de Genève, Geneva, Switzerland. 590919 Département de Pédiatrie, Gynécologie et Obstétrique (PETRI) author Rodriguez-Sibaja Maria Jose Instituto Nacional de Perinatología Isidro Espinosa de los Reyes, Mexico City, Mexico. author Livio Stefania Children's Hospital V Buzzi, ASST Fatebenefratelli Sacco, Milan, Italy. author Napolitano Raffaele Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK; Fetal Medicine Unit, University College London Hospitals NHS Foundation Trust, London, UK. author Maiz Nerea Maternal-Fetal Medicine Unit, Department of Obstetrics and Gynecology, Hospital Universitari Vall d'Hebron, Vall d'Hebron, Barcelona Hospital Campus, Universitat Autonoma de Barcelona, Barcelona, Spain. author Sobrero Helena Centro Hospitalario Pereira Rossell, Montevideo, Uruguay. author Peterson Ashley Tufts Medical Center, Boston, MA, USA. author Deruelle Philippe Department of Obstetrics and Gynecology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France. author Giudice Carolina Servicio de Neonatologia, Hospital Italiano de Buenos Aires, Instituto Universitario Hospital Italiano, Buenos Aires, Argentina. author Teji Jagjit S Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, IL, USA. author Casale Roberto A Maternal and Child Department, Hospital Nacional Profesor Alejandro Posadas, Buenos Aires, Argentina. author Salomon Laurent J Hôpital Universitaire Necker-Enfants Malades, Paris, France. author Prefumo Federico 0000-0001-7793-714X Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. author Cheikh Ismail Leila Department of Clinical Nutrition and Dietetics, College of Health Sciences, University of Sharjah, Sharjah, United Arab Emirates. author Gravett Michael G Department of Obstetrics and Gynecology and Department of Global Health, University of Washington, Seattle, WA, USA. author Vale Marynéa Hospital Universitário da Universidade Federal do Maranhão, São Luís, Maranhão, Brazil. author Hernández Valeria Facultad de Ciencias Médicas, Universidad Nacional de Córdoba, Córdoba, Argentina. author Sentilhes Loïc Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France. author Easter Sarah R Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. author Capelli Carola Servicio de Neonatología del Departamento Materno Infantil, Hospital Universitario Austral, Buenos Aires, Argentina. author Marler Emily St George's University Hospitals NHS Foundation Trust, London, UK. author Cáceres Daniela M Hospital Julio C Perrando, Resistencia, Chaco, Argentina. author Albornoz Crespo Guadalupe Clínica y Maternidad Suizo Argentina, Buenos Aires, Argentina. author Ernawati Ernawati Medical Faculty Universitas Airlangga - Dr Soetomo General Academic Hospital, Surabaya, Indonesia. author Lipschuetz Michal Obstetrics and Gynecology Division- Hadassah Medical Center Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel. author Takahashi Ken Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan. author Vecchiarelli Carmen Sanatorio Otamendi, Buenos Aires, Argentina. author Hubka Teresa Ascension-Resurrection Medical Center, Chicago, Illinois, USA. author Ikenoue Satoru 0000-0003-3652-5389 Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan. author Tavchioska Gabriela General Hospital With Extended Activity Prilep, Prilep, North Macedonia. author Bako Babagana Department of Obstetrics and Gynaecology, College of Medical Sciences, Gombe State University, Gombe, Nigeria. author Ayede Adejumoke I College of Medicine, University of Ibadan and University College Hospital, Ibadan, Nigeria. author Eskenazi Brenda Center for Environmental Research and Community Health (CERCH), School of Public Health, University of California, Berkeley, CA, USA. author Thornton Jim G University of Nottingham Medical School, University of Nottingham, Nottingham, UK. author Bhutta Zulfiqar A Department of Paediatrics and Child Health, The Aga Khan University Hospital, Karachi, Pakistan; Center for Global Child Health, Hospital for Sick Children, Toronto, ON, Canada. author Kennedy Stephen H Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK; Oxford Maternal and Perinatal Health Institute, Green Templeton College, University of Oxford, Oxford, UK. author Papageorghiou Aris T Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK; Oxford Maternal and Perinatal Health Institute, Green Templeton College, University of Oxford, Oxford, UK; St George's University Hospitals NHS Foundation Trust, London, UK. Electronic address: aris.papageorghiou@wrh.ox.ac.uk. INTERCOVID-2022 International Consortium collaborator Benski Anne Caroline 866921 collaborator Chilling Antonia collaborator Othenin-Girard Véronique 135225 Département de Pédiatrie, Gynécologie et Obstétrique (PETRI) collaborator Campelo Sonia 507424 collaborator Delecraz Dominique 646291 collaborator Cornut Léane Johanna Noa 928805 collaborator Phan Délia Monika Hoang Linh 923194 collaborator Da Silva Céline 134256 Département de Pédiatrie, Gynécologie et Obstétrique (PETRI) 447-457 10.1016/S0140-6736(22)02467-9 36669520 0140-6736 PMC9910845 https://www.sciencedirect.com/science/article/pii/S0140673622024679 Background: In 2021, we showed an increased risk associated with COVID-19 in pregnancy. Since then, the SARS-CoV-2 virus has undergone genetic mutations. We aimed to examine the effects on maternal and perinatal outcomes of COVID-19 during pregnancy, and evaluate vaccine effectiveness, when omicron (B.1.1.529) was the variant of concern. Methods: INTERCOVID-2022 is a large, prospective, observational study, involving 41 hospitals across 18 countries. Each woman with real-time PCR or rapid test, laboratory-confirmed COVID-19 in pregnancy was compared with two unmatched women without a COVID-19 diagnosis who were recruited concomitantly and consecutively in pregnancy or at delivery. Mother and neonate dyads were followed until hospital discharge. Primary outcomes were maternal morbidity and mortality index (MMMI), severe neonatal morbidity index (SNMI), and severe perinatal morbidity and mortality index (SPMMI). Vaccine effectiveness was estimated, adjusted by maternal risk profile. Findings: We enrolled 4618 pregnant women from Nov 27, 2021 (the day after WHO declared omicron a variant of concern), to June 30, 2022: 1545 (33%) women had a COVID-19 diagnosis (median gestation 36·7 weeks [IQR 29·0-38·9]) and 3073 (67%) women, with similar demographic characteristics, did not have a COVID-19 diagnosis. Overall, women with a diagnosis had an increased risk for MMMI (relative risk [RR] 1·16 [95% CI 1·03-1·31]) and SPMMI (RR 1·21 [95% CI 1·00-1·46]). Women with a diagnosis, compared with those without a diagnosis, also had increased risks of SNMI (RR 1·23 [95% CI 0·88-1·71]), although the lower bounds of the 95% CI crossed unity. Unvaccinated women with a COVID-19 diagnosis had a greater risk of MMMI (RR 1·36 [95% CI 1·12-1·65]). Severe COVID-19 symptoms in the total sample increased the risk of severe maternal complications (RR 2·51 [95% CI 1·84-3·43]), perinatal complications (RR 1·84 [95% CI 1·02-3·34]), and referral, intensive care unit (ICU) admission, or death (RR 11·83 [95% CI 6·67-20·97]). Severe COVID-19 symptoms in unvaccinated women increased the risk of MMMI (RR 2·88 [95% CI 2·02-4·12]) and referral, ICU admission, or death (RR 20·82 [95% CI 10·44-41·54]). 2886 (63%) of 4618 total participants had at least a single dose of any vaccine, and 2476 (54%) of 4618 had either complete or booster doses. Vaccine effectiveness (all vaccines combined) for severe complications of COVID-19 for all women with a complete regimen was 48% (95% CI 22-65) and 76% (47-89) after a booster dose. For women with a COVID-19 diagnosis, vaccine effectiveness of all vaccines combined for women with a complete regimen was 74% (95% CI 48-87) and 91% (65-98) after a booster dose. Interpretation: COVID-19 in pregnancy, during the first 6 months of omicron as the variant of concern, was associated with increased risk of severe maternal morbidity and mortality, especially among symptomatic and unvaccinated women. Women with complete or boosted vaccine doses had reduced risk for severe symptoms, complications, and death. Vaccination coverage among pregnant women remains a priority. Pregnancy Infant, Newborn Humans Female Male Pregnancy Outcome Vaccine Efficacy COVID-19 / diagnosis COVID-19 / epidemiology COVID-19 / prevention & control SARS-CoV-2 COVID-19 Testing Prospective Studies Mothers Dewey 618 58 Département de pédiatrie, gynécologie et obstétrique 223 false 213 Martinez De Tejada Begona 272 Lancet 401 10375 dcee76d7-246a-4544-9710-fef600f842e9 Article (Published version) Public Article_scientifique_from_europePmc.pdf 682572 application/pdf CC BY-4.0 89f0205772370d568a41ced3895a4eda29f1fe5dd5df19c4061a398cfa9aae88 a0441de8-0593-4d2c-8b7f-0388ed9bc0f3 Supplemental data Public 1-s2.0-S0140673622024679-mmc1.pdf 469322 application/pdf 21f5cbf60ecc34532cf2766a20aa48350b17fe57fc87f322005f57e338861d3b openAccess Faculté de médecine / Section de médecine clinique / Département de pédiatrie, gynécologie et obstétrique

Title	Published in	Access level	OA Policy	Year	Views	Downloads

Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022 : a multinational, observational study	Lancet			2023	90	109

Archive ouverte UNIGE

Phan, Délia Monika Hoang Linh