Maternal vaccination against COVID-19 and neonatal outcomes during Omicron: INTERCOVID-2022 study.
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.
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.
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.
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.
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.
Barros FC
，Gunier RB
，Rego A
，Sentilhes L
，Rauch S
，Gandino S
，Teji JS
，Thornton JG
，Kachikis AB
，Nieto R
，Craik R
，Cavoretto PI
，Winsey A
，Roggero P
，Rodriguez GB
，Savasi V
，Kalafat E
，Giuliani F
，Fabre M
，Benski AC
，Coronado-Zarco IA
，Livio S
，Ostrovska A
，Maiz N
，Castedo Camacho FR
，Peterson A
，Deruelle P
，Giudice C
，Casale RA
，Salomon LJ
，Soto Conti CP
，Prefumo F
，Mohamed Elbayoumy EZ
，Vale M
，Hernández V
，Chandler K
，Risso M
，Marler E
，Cáceres DM
，Crespo GA
，Ernawati E
，Lipschuetz M
，Ariff S
，Takahashi K
，Vecchiarelli C
，Hubka T
，Ikenoue S
，Tavchioska G
，Bako B
，Ayede AI
，Eskenazi B
，Bhutta ZA
，Kennedy SH
，Papageorghiou AT
，Villar J
，INTERCOVID-2022 International Consortium
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COVID-19 vaccine initiation in pregnancy and risk for adverse neonatal outcomes among United States military service members, January-December 2021.
The safety of primary series COVID-19 vaccine exposure in pregnancy has been well-studied; however, no research to date has been conducted among United States (US) military service members, a unique population with specific vaccination requirements for active duty service and early COVID-19 vaccine access.
This retrospective cohort study leveraged data from the Department of Defense Birth and Infant Health Research program to identify live births among active duty US military service members in calendar year 2021. Administrative military personnel data, immunization files, and medical encounter records were used to develop study variables and determine COVID-19 vaccine receipt in pregnancy. Cox and modified Poisson regression models estimated hazard (HR) and risk ratios (RR), respectively, with 95 % confidence intervals (CI) for vaccine receipt and selected neonatal outcomes; models were adjusted for baseline characteristics using inverse probability of treatment weighting and further adjusted for SARS-CoV-2 infection in pregnancy.
There were 7184 singleton live births included for analysis, of which 2867 (39.9 %) were among service members exposed to their first COVID-19 vaccine dose in pregnancy and 4317 (60.1 %) among service members unexposed to any COVID-19 vaccine during or prior to pregnancy. Baseline differences between exposed and unexposed service members (e.g., age, race and ethnicity, marital status, occupation) were fully attenuated after applying weights. COVID-19 vaccine initiation in pregnancy was not associated with preterm birth (<37 weeks' gestation; adjusted HR: 1.02, 95 % CI: 0.83-1.26), small for gestational age (<10th percentile; adjusted HR: 1.01, 95 % CI: 0.78-1.30), low birthweight (<2500 g; adjusted HR: 1.01, 95 % CI: 0.80-1.28), or neonatal intensive care unit admission (adjusted RR: 0.90, 95 % CI: 0.75-1.07).
Primary series COVID-19 vaccine exposure in pregnancy was common in this military cohort. Vaccine receipt was not associated with increased risk for any adverse outcome under study, substantiating findings from existing literature.
Hall C
，Lanning J
，Romano CJ
，Bukowinski AT
，Gumbs GR
，Conlin AMS
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