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

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. FUNDING: None.

Infección tardía por Streptococcus agalactiae asociada a la leche humana: reporte de 3 casos clínicos / Streptococcus agalactiae late onset infection associated with human milk: three cases report

La infección por estreptococo ß-hemolítico del grupo B o Streptococcus agalactiae puede causar morbilidad grave y mortalidad en los recién nacidos, especialmente en prematuros. Las estrategias de prevención actuales han sido eficaces en reducir la frecuencia de sepsis neonatal temprana ocasionada por transmisión vertical. La incidencia de sepsis tardía por dicho microrganismo no se ha modificado y la vía de infección es menos clara. En niños amamantados, la transmisión a través de la leche materna es posible. Se presentan tres casos de infección tardía por estreptococo ß-hemolítico del grupo B en recién nacidos prematuros alimentados con leche materna cuyas madres tenían mastitis. En todos los casos, tanto en el cultivo de la leche materna como en los hemocultivos de los neonatos se desarrolló el mismo microrganismo.

Group B ß-hemolytic Streptococcus or Streptococcus agalactiae is a major cause of morbidity and mortality in neonates, especially in premature infants. Current prevention strategies have been effective in reducing the frequency of early onset neonatal sepsis caused by vertical transmission. The incidence of late onset sepsis due to this microorganism has not changed and the route of infection is less clear. In breastfed infants, transmission through breast milk is possible. We report three cases of late group B ß-hemolytic streptococcal infection in breastfed preterm infants whose mothers had mastitis. In all cases, both the breast milk culture and the blood cultures of the neonates developed the same microorganism.

[Streptococcus agalactiae late onset infection associated with human milk: three cases report]. / Infección tardía por Streptococcus agalactiae asociada a la leche humana: reporte de 3 casos clínicos.

Group B ß-hemolytic Streptococcus or Streptococcus agalactiae is a major cause of morbidity and mortality in neonates, especially in premature infants. Current prevention strategies have been effective in reducing the frequency of early onset neonatal sepsis caused by vertical transmission. The incidence of late onset sepsis due to this microorganism has not changed and the route of infection is less clear. In breastfed infants, transmission through breast milk is possible. We report three cases of late group B ß-hemolytic streptococcal infection in breastfed preterm infants whose mothers had mastitis. In all cases, both the breast milk culture and the blood cultures of the neonates developed the same microorganism.

La infección por estreptococo ß-hemolítico del grupo B o Streptococcus agalactiae puede causar morbilidad grave y mortalidad en los recién nacidos, especialmente en prematuros. Las estrategias de prevención actuales han sido eficaces en reducir la frecuencia de sepsis neonatal temprana ocasionada por transmisión vertical. La incidencia de sepsis tardía por dicho microrganismo no se ha modificado y la vía de infección es menos clara. En niños amamantados, la transmisión a través de la leche materna es posible. Se presentan tres casos de infección tardía por estreptococo ß-hemolítico del grupo B en recién nacidos prematuros alimentados con leche materna cuyas madres tenían mastitis. En todos los casos, tanto en el cultivo de la leche materna como en los hemocultivos de los neonatos se desarrolló el mismo microrganismo.