TY - JOUR
T1 - Maternal vaccination against COVID-19 and neonatal outcomes during Omicron
T2 - INTERCOVID-2022 study
AU - INTERCOVID-2022 International Consortium
AU - Barros, Fernando C.
AU - Gunier, Robert B.
AU - Rego, Albertina
AU - Sentilhes, Loïc
AU - Rauch, Stephen
AU - Gandino, Serena
AU - Teji, Jagjit S.
AU - Thornton, Jim G.
AU - Kachikis, Alisa B.
AU - Nieto, Ricardo
AU - Craik, Rachel
AU - Cavoretto, Paolo I.
AU - Winsey, Adele
AU - Roggero, Paola
AU - Rodriguez, Gabriel B.
AU - Savasi, Valeria
AU - Kalafat, Erkan
AU - Giuliani, Francesca
AU - Fabre, Marta
AU - Benski, Anne Caroline
AU - Coronado-Zarco, Irma Alejandra
AU - Livio, Stefania
AU - Ostrovska, Adela
AU - Maiz, Nerea
AU - Castedo Camacho, Fabiola R.
AU - Peterson, Ashley
AU - Deruelle, Philippe
AU - Giudice, Carolina
AU - Casale, Roberto A.
AU - Salomon, Laurent J.
AU - Soto Conti, Constanza P.
AU - Prefumo, Federico
AU - Mohamed Elbayoumy, Ehab Zakaria
AU - Vale, Marynéa
AU - Hernández, Valeria
AU - Chandler, Katherine
AU - Risso, Milagros
AU - Marler, Emily
AU - Cáceres, Daniela M.
AU - Crespo, Guadalupe Albornoz
AU - Ernawati, Ernawati
AU - Lipschuetz, Michal
AU - Ariff, Shabina
AU - Takahashi, Ken
AU - Vecchiarelli, Carmen
AU - Hubka, Teresa
AU - Ikenoue, Satoru
AU - Tavchioska, Gabriela
AU - Bako, Babagana
AU - Ayede, Adejumoke I.
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/10
Y1 - 2024/10
N2 - Background: In early 2023, when Omicron was the variant of concern, we showed that vaccinating pregnant women decreased the risk for severe COVID-19–related complications and maternal morbidity and mortality. Objective: This study aimed to analyze the impact of COVID-19 during pregnancy on newborns and the effects of maternal COVID-19 vaccination on neonatal outcomes when Omicron was the variant of concern. Study Design: INTERCOVID-2022 was a large, prospective, observational study, conducted in 40 hospitals across 18 countries, from November 27, 2021 (the day after the World Health Organization declared Omicron the variant of concern) to June 30, 2022, to assess the effect of COVID-19 in pregnancy on maternal and neonatal outcomes and to assess vaccine effectiveness. Women diagnosed with laboratory-confirmed COVID-19 during pregnancy were compared with 2 nondiagnosed, unmatched women recruited concomitantly and consecutively during pregnancy or at delivery. Mother-newborn dyads were followed until hospital discharge. The primary outcomes were a neonatal positive test for COVID-19, severe neonatal morbidity index, severe perinatal morbidity and mortality index, preterm birth, neonatal death, referral to neonatal intensive care unit, and diseases during the neonatal period. Vaccine effectiveness was estimated with adjustment for maternal risk profile. Results: We enrolled 4707 neonates born to 1577 (33.5%) mothers diagnosed with COVID-19 and 3130 (66.5%) nondiagnosed mothers. Among the diagnosed mothers, 642 (40.7%) were not vaccinated, 147 (9.3%) were partially vaccinated, 551 (34.9%) were completely vaccinated, and 237 (15.0%) also had a booster vaccine. Neonates of booster-vaccinated mothers had less than half (relative risk, 0.46; 95% confidence interval, 0.23–0.91) the risk of being diagnosed with COVID-19 when compared with those of unvaccinated mothers; they also had the lowest rates of preterm birth, medically indicated preterm birth, respiratory distress syndrome, and number of days in the neonatal intensive care unit. Newborns of unvaccinated mothers had double the risk for neonatal death (relative risk, 2.06; 95% confidence interval, 1.06–4.00) when compared with those of nondiagnosed mothers. Vaccination was not associated with any congenital malformations. Although all vaccines provided protection against neonatal test positivity, newborns of booster-vaccinated mothers had the highest vaccine effectiveness (64%; 95% confidence interval, 10%–86%). Vaccine effectiveness was not as high for messenger RNA vaccines only. Vaccine effectiveness against moderate or severe neonatal outcomes was much lower, namely 13% in the booster-vaccinated group (all vaccines) and 25% and 28% in the completely and booster-vaccinated groups, respectively (messenger RNA vaccines only). Vaccines were fairly effective in protecting neonates when given to pregnant women ≤100 days (14 weeks) before birth; thereafter, the risk increased and was much higher after 200 days (29 weeks). Finally, none of the neonatal practices studied, including skin-to-skin contact and direct breastfeeding, increased the risk for infecting newborns. Conclusion: When Omicron was the variant of concern, newborns of unvaccinated mothers had an increased risk for neonatal death. Neonates of vaccinated mothers had a decreased risk for preterm birth and adverse neonatal outcomes. Because the protective effect of COVID-19 vaccination decreases with time, to ensure that newborns are maximally protected against COVID-19, mothers should receive a vaccine or booster dose no more than 14 weeks before the expected date of delivery.
AB - Background: In early 2023, when Omicron was the variant of concern, we showed that vaccinating pregnant women decreased the risk for severe COVID-19–related complications and maternal morbidity and mortality. Objective: This study aimed to analyze the impact of COVID-19 during pregnancy on newborns and the effects of maternal COVID-19 vaccination on neonatal outcomes when Omicron was the variant of concern. Study Design: INTERCOVID-2022 was a large, prospective, observational study, conducted in 40 hospitals across 18 countries, from November 27, 2021 (the day after the World Health Organization declared Omicron the variant of concern) to June 30, 2022, to assess the effect of COVID-19 in pregnancy on maternal and neonatal outcomes and to assess vaccine effectiveness. Women diagnosed with laboratory-confirmed COVID-19 during pregnancy were compared with 2 nondiagnosed, unmatched women recruited concomitantly and consecutively during pregnancy or at delivery. Mother-newborn dyads were followed until hospital discharge. The primary outcomes were a neonatal positive test for COVID-19, severe neonatal morbidity index, severe perinatal morbidity and mortality index, preterm birth, neonatal death, referral to neonatal intensive care unit, and diseases during the neonatal period. Vaccine effectiveness was estimated with adjustment for maternal risk profile. Results: We enrolled 4707 neonates born to 1577 (33.5%) mothers diagnosed with COVID-19 and 3130 (66.5%) nondiagnosed mothers. Among the diagnosed mothers, 642 (40.7%) were not vaccinated, 147 (9.3%) were partially vaccinated, 551 (34.9%) were completely vaccinated, and 237 (15.0%) also had a booster vaccine. Neonates of booster-vaccinated mothers had less than half (relative risk, 0.46; 95% confidence interval, 0.23–0.91) the risk of being diagnosed with COVID-19 when compared with those of unvaccinated mothers; they also had the lowest rates of preterm birth, medically indicated preterm birth, respiratory distress syndrome, and number of days in the neonatal intensive care unit. Newborns of unvaccinated mothers had double the risk for neonatal death (relative risk, 2.06; 95% confidence interval, 1.06–4.00) when compared with those of nondiagnosed mothers. Vaccination was not associated with any congenital malformations. Although all vaccines provided protection against neonatal test positivity, newborns of booster-vaccinated mothers had the highest vaccine effectiveness (64%; 95% confidence interval, 10%–86%). Vaccine effectiveness was not as high for messenger RNA vaccines only. Vaccine effectiveness against moderate or severe neonatal outcomes was much lower, namely 13% in the booster-vaccinated group (all vaccines) and 25% and 28% in the completely and booster-vaccinated groups, respectively (messenger RNA vaccines only). Vaccines were fairly effective in protecting neonates when given to pregnant women ≤100 days (14 weeks) before birth; thereafter, the risk increased and was much higher after 200 days (29 weeks). Finally, none of the neonatal practices studied, including skin-to-skin contact and direct breastfeeding, increased the risk for infecting newborns. Conclusion: When Omicron was the variant of concern, newborns of unvaccinated mothers had an increased risk for neonatal death. Neonates of vaccinated mothers had a decreased risk for preterm birth and adverse neonatal outcomes. Because the protective effect of COVID-19 vaccination decreases with time, to ensure that newborns are maximally protected against COVID-19, mothers should receive a vaccine or booster dose no more than 14 weeks before the expected date of delivery.
KW - COVID-19
KW - COVID-19 vaccination
KW - SARS-CoV-2
KW - SARS-CoV-2 exposure
KW - morbidity
KW - mortality
KW - multicenter study
KW - neonatal health
KW - neonatal intensive care admission
KW - neonatal outcomes
KW - neurologic outcomes
KW - newborn
KW - perinatal practices
KW - pregnancy
KW - preterm birth
KW - respiratory support
KW - respiratory symptoms
KW - skin-to-skin
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U2 - 10.1016/j.ajog.2024.02.008
DO - 10.1016/j.ajog.2024.02.008
M3 - Article
C2 - 38367758
AN - SCOPUS:85187385365
SN - 0002-9378
VL - 231
SP - 460.e1-460.e17
JO - American Journal of Obstetrics and Gynecology
JF - American Journal of Obstetrics and Gynecology
IS - 4
ER -