1. Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study
- Author
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Jose Villar, Constanza P Soto Conti, Robert B Gunier, Shabina Ariff, Rachel Craik, Paolo I Cavoretto, Stephen Rauch, Serena Gandino, Ricardo Nieto, Adele Winsey, Camilla Menis, Gabriel B Rodriguez, Valeria Savasi, Niyazi Tug, Sonia Deantoni, Marta Fabre, Begoña Martinez de Tejada, Maria Jose Rodriguez-Sibaja, Stefania Livio, Raffaele Napolitano, Nerea Maiz, Helena Sobrero, Ashley Peterson, Philippe Deruelle, Carolina Giudice, Jagjit S Teji, Roberto A Casale, Laurent J Salomon, Federico Prefumo, Leila Cheikh Ismail, Michael G Gravett, Marynéa Vale, Valeria Hernández, Loïc Sentilhes, Sarah R Easter, Carola Capelli, Emily Marler, Daniela M Cáceres, Guadalupe Albornoz Crespo, Ernawati Ernawati, Michal Lipschuetz, Ken Takahashi, Carmen Vecchiarelli, Teresa Hubka, Satoru Ikenoue, Gabriela Tavchioska, Babagana Bako, Adejumoke I Ayede, Brenda Eskenazi, Jim G Thornton, Zulfiqar A Bhutta, Stephen H Kennedy, Aris T Papageorghiou, Institut Català de la Salut, [Villar J] 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. [Soto Conti CP] Division Neonatología, Hospital Materno Infantil Ramón Sarda, Buenos Aires, Argentina. [Gunier RB] Center for Environmental Research and Community Health (CERCH), School of Public Health, University of California, Berkeley, CA, USA. [Ariff S] Department of Paediatrics and Child Health, The Aga Khan University Hospital, Karachi, Pakistan. [Craik R] Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK. [Cavoretto PI] Vita-Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Obstetrics and Gynaecology Department, Milan, Italy. [Maiz N] Unitat de Medicina Fetal, Unitat Docent d’Obstetrícia i Ginecologia, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain, and Vall d'Hebron Barcelona Hospital Campus more...
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Complex Mixtures::Biological Products::Vaccines [CHEMICALS AND DRUGS] ,diagnóstico::pronóstico::resultado del embarazo [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Embaràs ,Medicaments - Eficàcia ,virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES] ,Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES] ,General Medicine ,Diagnosis::Prognosis::Pregnancy Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,COVID-19 (Malaltia) - Vacunació ,mezclas complejas::productos biológicos::vacunas [COMPUESTOS QUÍMICOS Y DROGAS] - Abstract
Pregnancy outcomes; Vaccine effectiveness; Omicron Resultados del embarazo; Efectividad de la vacuna; Omicron Resultats de l'embaràs; Eficàcia de la vacuna; Omicron 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. more...
- Published
- 2023