The impact of COVID-19 monoclonal antibodies on clinical outcomes: A retrospective cohort study.

PURPOSE: Despite progress in the treatment of coronavirus disease 2019 (COVID-19), including the development of monoclonal antibodies (mAbs), more clinical data to support the use of mAbs in outpatients with COVID-19 is needed. This study is designed to determine the impact of bamlanivimab, bamlanivimab/etesevimab, or casirivimab/imdevimab on clinical outcomes within 30 days of COVID-19 diagnosis. METHODS: A retrospective cohort study was conducted at a single academic medical center with 3 campuses in Manhattan, Brooklyn, and Long Island, NY. Patients 12 years of age or older who tested positive for COVID-19 or were treated with a COVID-19-specific therapy, including COVID-19 mAb therapies, at the study site between November 24, 2020, and May 15, 2021, were included. The primary outcomes included rates of emergency department (ED) visit, inpatient admission, intensive care unit (ICU) admission, or death within 30 days from the date of COVID-19 diagnosis. RESULTS: A total of 1,344 mAb-treated patients were propensity matched to 1,344 patients with COVID-19 patients who were not treated with mAb therapy. Within 30 days of diagnosis, among the patients who received mAb therapy, 101 (7.5%) presented to the ED and 79 (5.9%) were admitted. Among the patients who did not receive mAb therapy, 165 (12.3%) presented to the ED and 156 (11.6%) were admitted (relative risk [RR], 0.61 [95% CI, 0.50-0.75] and 0.51 [95% CI, 0.40-0.64], respectively). Four mAb patients (0.3%) and 2.64 control patients (0.2%) were admitted to the ICU (RR, 01.51; 95% CI, 0.45-5.09). Six mAb-treated patients (0.4%) and 3.37 controls (0.3%) died and/or were admitted to hospice (RR, 1.61; 95% CI, 0.54-4.83). mAb therapy in ambulatory patients with COVID-19 decreases the risk of ED presentation and hospital admission within 30 days of diagnosis.

COVID-19 vaccination in pregnancy: early experience from a single institution.

OBJECTIVE: Pregnant women are at increased risk for morbidity owing to infection with the COVID-19 virus.1 Vaccination presents an important strategy to mitigate illness in this population. However, there is a paucity of data on vaccination safety and pregnancy outcomes because pregnant women were excluded from the initial phase III clinical trials. Our objective was to describe the maternal, neonatal, and obstetrical outcomes of women who received a messenger RNA (mRNA) COVID-19 vaccination while pregnant during the first 4 months of vaccine availability. STUDY DESIGN: This was an institutional review board-approved descriptive study of pregnant women at New York University Langone Health who received at least 1 dose of an mRNA COVID-19 vaccination approved by the US Food and Drug Administration (FDA) (Pfizer-BioNTech or Moderna) from the time of the FDA Emergency Use Authorization to April 22, 2021. Eligible women were identified via search of the electronic medical record (EMR) system. Vaccine administration was ascertained via immunization records from the New York State Department of Health. Women were excluded if they were vaccinated before conception or during the postpartum period. Charts were reviewed for maternal demographics and pregnancy outcomes. Descriptive analyses were performed using the R software version 4.0.2 (The R Foundation, Boston, MA). RESULTS: We identified 424 pregnant women who received an mRNA vaccination. Of those, 348 (82.1%) received both doses and 76 (17.9%) received only 1 dose. The maternal characteristics and vaccination information are shown in Table 1. Of the included women, 4.9% had a history of a confirmed COVID-19 diagnosis before vaccination. After vaccination, no patient in our cohort was diagnosed with COVID-19. In terms of the pregnancy outcomes, 9 women had spontaneous abortions, 3 terminated their pregnancies, and 327 have ongoing pregnancies. Of the women included, 85 delivered liveborn infants. There were no stillbirths in our population. Of the 9 spontaneous abortions, 8 occurred during the first trimester at a range of 6 to 13 weeks' gestation. There was 1 second trimester loss. The rate of spontaneous abortion among women vaccinated in the first trimester was 6.5%. The 327 women with ongoing pregnancies have been followed for a median of 4.6 weeks (range, 0-17 weeks) following their most recent dose. A total of 113 (34.6%) women, initiated vaccination during the first trimester, 178 (54.4%) initiated vaccination during the second trimester, and 36 (11.0%) during the third trimester. Following the vaccination, 2 fetuses (0.6%) developed intrauterine growth restriction, whereas 5 (1.5%) were diagnosed with anomalies. Outcomes for the 85 women who delivered are shown in Table 2. Of the women who delivered, 18.8% were diagnosed with a hypertensive disorder of pregnancy. The rate of preterm birth was 5.9%. One preterm delivery was medically indicated, whereas the remaining 3 were spontaneous. A total of 15.3% of neonates required admission to the neonatal intensive care unit (NICU). Of the NICU admissions, 61.5% were because of hypoglycemia or an evaluation for sepsis. Other reasons for admission included prematurity, hypothermia, and transient tachypnea of the newborn. Of all the neonates, 12.2% were small for gestational age (SGA) per the World Health Organization standards. CONCLUSION: This series describes our experience with women who received an mRNA COVID-19 vaccine during pregnancy. In line with other published findings,2 we observed no concerning trends. There were no stillbirths. Our 6.5% rate of spontaneous abortion is within the expected rate of 10%,3 and our preterm birth rate of 5.9% is below the national average of 9.5%.4 Our rate of pregnancy-related hypertensive disorders is higher than our baseline institutional rate of 9.5%, however, this may be because of the underlying characteristics of our study population or skewing of our small sample size. Our 12.2% rate of SGA neonates is near the expected value based on the definition that 10% of neonates will be SGA at birth. The NICU admission rate is at par with our institutional rate of 12%. To date, most women in this series have had uncomplicated pregnancies and have delivered at-term. Strengths of this study include using the EMR system to identify subjects and gather data. We did not rely on self-enrollment and self-report, thereby reducing selection and recall bias. By performing manual chart reviews, we obtained detailed and reliable information about individual patients. One limitation of this study is the lack of a matched control group consisting of unvaccinated pregnant women and therefore direct conclusions could not be drawn about the relative risks of complications. In addition, our cohort is small and may not be generalizable. Finally, many women included are healthcare workers who had early access to vaccinations. As more pregnant women become eligible for the COVID-19 vaccinations, there is an urgent need to report on the maternal, neonatal, and obstetrical outcomes of COVID-19 vaccinations during pregnancy. The results of this study can be used to counsel and reassure pregnant patients facing this decision.

A modern measles outbreak: understanding maternal immunity and impact on postpartum vaccination uptake.

BACKGROUND: In October 2018, a measles (rubeola) outbreak was identified in New York City and Rockland County, and a public health campaign and hospital policy changes were made to increase awareness of the importance of vaccination and increase vaccination rates. OBJECTIVE: We describe the prevalence of rubeola immunity in pregnant women and the change in uptake of postpartum measles, mumps, and rubella vaccination before and during the measles outbreak. STUDY DESIGN: A multipronged intervention was developed by the health system with the intent of raising awareness of the outbreak, identifying patients at risk of contracting measles during pregnancy, and limiting exposure of inpatients to the disease. This was a quality improvement study to assess the impact of the intervention and public health policy on the rates of documentation of rubeola immunity and rubeola vaccination rates in nonimmune women. Women who delivered at New York University Langone Health before the outbreak July 1, 2016 to July 1, 2017 were compared with women who delivered during the outbreak July 1, 2018 to July 1, 2019. The primary outcome was acceptance of measles, mumps, and rubella vaccination in nonimmune women during the postpartum period. Analysis was conducted using logistic regression and chi-square tests, and alpha was set at 0.05. RESULTS: A total of 19,585 patients were analyzed; 9162 women delivered before the outbreak and 10,423 delivered during the outbreak. Of these, 2589 (13.2%) were documented as living in a high-risk zone improvement plan code, which were areas at the epicenter of the measles outbreak. Notably, 14,731 women (75.2%) were tested for rubeola immunity and 3270 of those tested (22.2%) were not immune. In the year of the outbreak, a higher proportion of women had rubeola immunity documented with serum titers than in the year before the outbreak (81% vs 69%; P<.001). Inpatient compliance with postpartum measles, mumps, and rubella administration was greater during the outbreak than before it (76% vs 59%; P<.001) for patients from both low-risk and high-risk zone improvement plan codes. CONCLUSION: The New York City and Rockland County measles outbreak, together with the implementation of a health system-wide education program and a change in public health policy, led to an increase in the proportion of pregnant women being screened for rubeola immunity. It also led to an increase in uptake of the immediate postpartum measles, mumps, and rubella vaccine.

Characteristics of Hospitalized Children With SARS-CoV-2 in the New York City Metropolitan Area.

OBJECTIVES: To describe the characteristics of hospitalized children with severe acute respiratory syndrome coronavirus 2 in New York City metropolitan area. PATIENTS AND METHODS: This was a multicenter, retrospective cohort study at 4 hospitals comprising 82 hospitalized children (0-21 years) who tested positive for severe acute respiratory syndrome coronavirus 2 after symptoms and risk screening between March 1 and May 10, 2020. We subdivided patients on the basis of their admission to acute or critical care units and by age groups. Further subanalyses were performed between patients requiring respiratory support or no respiratory support. RESULTS: Twenty-three (28%) patients required critical care. Twenty-nine (35%) patients requiring respiratory support, with 9% needing mechanical ventilation, and 1 required extracorporeal support. All patients survived to discharge. Children with any comorbidity were more likely to require critical care (70% vs 37%, P = .008), with obesity as the most common risk factor for critical care (63% vs 28%, P = .02). Children with asthma were more likely to receive respiratory support (28% vs 8%, P = .02), with no difference in need for critical care (P = .26). Children admitted to critical care had higher rates of renal dysfunction at presentation (43% vs 10%, P = .002). CONCLUSIONS: Children with comorbidities (obesity and asthma in particular) were at increased risk for critical care admission and/or need for respiratory support. Children with renal dysfunction at presentation were more likely to require critical care.

Outcomes of Maternal-Newborn Dyads After Maternal SARS-CoV-2.

BACKGROUND AND OBJECTIVES: Infection with a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. There are limited data describing the impact of SARS-CoV-2 infection on pregnant mothers and their newborns. The objective of this study is to describe characteristics and outcomes of maternal-newborn dyads with confirmed maternal SARS-CoV-2. METHODS: This was a multicenter, observational, descriptive cohort study with data collection from charts of maternal-newborn dyads who delivered at 4 major New York City metropolitan area hospitals between March 1 and May 10, 2020, with maternal SARS-CoV-2 infection. RESULTS: There were a total of 149 mothers with SARS-CoV-2 infection and 149 newborns analyzed (3 sets of twins; 3 stillbirths). Forty percent of these mothers were asymptomatic. Approximately 15% of symptomatic mothers required some form of respiratory support, and 8% required intubation. Eighteen newborns (12%) were admitted to the ICU. Fifteen (10%) were born preterm, and 5 (3%) required mechanical ventilation. Symptomatic mothers had more premature deliveries (16% vs 3%, P = .02), and their newborns were more likely to require intensive care (19% vs 2%, P = .001) than asymptomatic mothers. One newborn tested positive for SARS-CoV-2, which was considered a case of horizontal postnatal transmission. CONCLUSIONS: Although there was no distinct evidence of vertical transmission from mothers with SARS-CoV-2 to their newborns, we did observe perinatal morbidities among both mothers and newborns. Symptomatic mothers were more likely to experience premature delivery and their newborns to require intensive care.

Neonatal intensive care unit preparedness for the Novel Coronavirus Disease-2019 pandemic: A New York City hospital perspective.

In January 2020, China reported a cluster of cases of pneumonia associated with a novel pathogenic coronavirus provisionally named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2). Since then, Coronavirus Disease 2019 (COVID-19) has been reported in more than 180 countries with approximately 6.5 million known infections and more than 380,000 deaths attributed to this disease as of June 3rd , 2020 (Johns Hopkins University COVID map; https://coronavirus.jhu.edu/map.html) The majority of confirmed COVID-19 cases have been reported in adults, especially older individuals with co-morbidities. Children have had a relatively lower rate and a less serious course of infection as reported in the literature to date. One of the most vulnerable pediatric patient populations is cared for in the neonatal intensive care unit. There is limited data on the effect of COVID-19 in fetal life, and among neonates after birth. Therefore there is an urgent need for proactive preparation, and planning to combat COVID-19, as well as to safeguard patients, their families, and healthcare personnel. This review article is based on the Centers for Disease Control and Prevention's (CDC) current recommendations for COVID-19 and its adaptation to our local resources. The aim of this article is to provide basic consolidated guidance and checklists to clinicians in the neonatal intensive care units in key aspects of preparation needed to counter exposure or infection with COVID-19. We anticipate that CDC will continue to update their guidelines regarding COVID-19 as the situation evolves, and we recommend monitoring CDC's updates for the most current information.