Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study.
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Villar Jose, Soto Conti Constanza P, Gunier Robert B, Ariff Shabina, Craik Rachel, Cavoretto Paolo I, Rauch Stephen, Gandino Serena, Nieto Ricardo, Winsey Adele, Menis Camilla, Rodriguez Gabriel B, Savasi Valeria, Tug Niyazi, Deantoni Sonia, Fabre Marta, Martinez de Tejada Begoña, Rodriguez-Sibaja Maria Jose, Livio Stefania, Napolitano Raffaele, Maiz Nerea, Sobrero Helena, Peterson Ashley, Deruelle Philippe, Giudice Carolina, Teji Jagjit S, Casale Roberto A, Salomon Laurent J, Prefumo Federico, Cheikh Ismail Leila, Gravett Michael G, Vale Marynéa, Hernández Valeria, Sentilhes Loïc, Easter Sarah R, Capelli Carola, Marler Emily, Cáceres Daniela M, Albornoz Crespo Guadalupe, Ernawati Ernawati, Lipschuetz Michal, Takahashi Ken, Vecchiarelli Carmen, Hubka Teresa, Ikenoue Satoru, Tavchioska Gabriela, Bako Babagana, Ayede Adejumoke I, Eskenazi Brenda, Thornton Jim G, Bhutta Zulfiqar A, Kennedy Stephen H, Papageorghiou Aris T, INTERCOVID-2022 International Consortium
Аннотация
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.
FUNDING: None.