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1.
Preprint in English | medRxiv | ID: ppmedrxiv-22278727

ABSTRACT

BackgroundCOVID-19 infection in pregnant people has previously been shown to increase the risk for poor maternal-fetal outcomes. Despite this, there has been a lag in COVID-19 vaccination in pregnant people due to concerns over the potential effects of the vaccine on maternal-fetal outcomes. Here we examine the impact of COVID-19 vaccination and booster on maternal COVID-19 breakthrough infections and birth outcomes. MethodsThis was a retrospective multicenter cohort study on the impact of COVID-19 vaccination on maternal-fetal outcomes for people that delivered (n=86,833) at Providence St. Joseph Health across Alaska, California, Montana, Oregon, New Mexico, Texas, and Washington from January 26, 2021 through July 11, 2022. Cohorts were defined by vaccination status at time of delivery: unvaccinated (n=48,492), unvaccinated propensity score matched (n=26,790), vaccinated (n=26,792; two doses of mRNA-1273 Moderna or BNT162b2 Pfizer-BioNTech), and/or boosted (n=7,616). The primary outcome was maternal COVID-19 infection. COVID-19 vaccination status at delivery, COVID-19 infection-related health care, preterm birth (PTB), stillbirth, very low birth weight (VLBW), and small for gestational age (SGA) were evaluated as secondary outcomes. FindingsVaccinated pregnant people were significantly less likely to have a maternal COVID-19 infection than unvaccinated matched (p<0.0001) pregnant people. During a maternal COVID-19 infection, vaccinated pregnant people had similar rates of hospitalization (p=0.23), but lower rates of supplemental oxygen (p<0.05) or vasopressor (p<0.05) use than those in an unvaccinated matched cohort. Compared to an unvaccinated matched cohort, vaccinated people had significantly lower stillbirth rate (p<0.01) as well as no difference in rate of PTB (p=0.35), SGA (p=0.79), or rate of VLBW (>1,500 g; 0.31). Vaccinated people who were boosted had significantly lower rates of maternal COVID-19 infections (p<0.0001), COVID-19 related hospitalization (p<0.05), PTB (p<0.05), stillbirth (p<0.01), SGA (p<0.05), and VLBW (p<0.01), compared to vaccinated people that did not receive a third booster dose five months after completing the initial vaccination series. InterpretationCOVID-19 vaccination protects against adverse maternal-fetal outcomes with booster doses conferring additional protection against COVID-19 infection. It is therefore important for pregnant people to have high priority status for vaccination, and for them to stay current with their COVID-19 vaccination schedule. FundingThis study was funded by the National Institute for Child Health & Human Development and the William O. and K. Carole Ellison Foundation.

2.
Preprint in English | medRxiv | ID: ppmedrxiv-22270613

ABSTRACT

BackgroundIt is important to understand how BNT162b2, mRNA-1273, and JNJ-78436735 COVID-19 vaccines, as well as prior infection, protect against breakthrough cases and reinfections. Real world evidence on acquired immunity from vaccines, and from SARS-CoV-2 infection, can help public health decision-makers understand disease dynamics and viral escape to inform resource allocation for curbing the spread of pandemic. MethodsThis retrospective cohort study presents demographic information, survival functions, and probability distributions for 2,627,914 patients who received recommended doses of COVID-19 vaccines, and 63,691 patients who had a prior COVID-19 infection. In addition, patients receiving different vaccines were matched by age, sex, ethnic group, state of residency, and the quarter of the year in 2021 the COVID-19 vaccine was completed, to support survival analysis on pairwise matched cohorts. FindingsEach of the three vaccines and infection-induced immunity all showed a high probability of survival against breakthrough or reinfection cases (mRNA-1273: 0.997, BNT162b2: 0.997, JNJ-78436735: 0.992, previous infection: 0.965 at 180 days). The incidence rate of reinfection among those unvaccinated and previously infected was higher than that of breakthrough among the vaccinated population (reinfection: 0.9%; breakthrough:0.4%). In addition, 280 vaccinated patients died (0.01% all-cause mortality) within 21 days of the last vaccine dose, and 5898 (3.1 %) died within 21 days of a positive COVID-19 test. ConclusionsDespite a gradual decline in vaccine-induced and infection-induced immunity, both acquired immunities were highly effective in preventing breakthrough and reinfection. In addition, for unvaccinated patients with COVID-19, those who did not die within 90 days of their initial infection (9565 deaths, 5.0% all-cause mortality rate), had a comparable asymptotic pattern of breakthrough infection as those who acquired immunity from a vaccine. Overall, the risks associated with COVID-19 infection are far greater than the marginal advantages of immunity acquired by prior infection.

3.
Preprint in English | medRxiv | ID: ppmedrxiv-22270287

ABSTRACT

BackgroundRisk stratification for hospitalized adults with COVID-19 is essential to inform decisions for individual patients and allocation of potentially scarce resources. So far, risk models for severe COVID outcomes have included age but have not been optimized to best serve the needs of either older or younger adults. Additionally, existing risk models have been limited to either small sample sizes, or modeling mortality over an entire hospital admission. Further, previous models were developed on data from early in the pandemic, before improvements in COVID-19 treatment, the SARS-CoV-2 delta variant, and vaccination. There remains a need for early, accurate identification of patients who may need invasive mechanical ventilation (IMV) or die, considering multiple time horizons. MethodsThis retrospective study analyzed data from 6,906 hospitalized adults with COVID-19 from a community health system with 51 hospitals and 1085 clinics across five states in the western United States. Risk models were developed to predict mechanical ventilation illness or death across one to 56 days of hospitalization, using clinical data collected available within the first hour after either admission with COVID-19 or a first positive SARS-CoV-2 test. The relative importance of predictive risk factors features for all models was determined using Shapley additive explanations. FindingsThe percentage of patients who required mechanical ventilation or died within seven days of admission to the hospital due to COVID-19 was 10.82%. For the seven-day interval, models for age [≥] 18 and < 50 years reached AUROC 0.80 (95% CI: 0.70-0.89) and models for age [≥] 50 years reached AUROC 0.83 (95% CI: 0.79-0.88). Models revealed differences in the statistical significance and relative predictive value of risk factors between older and younger patients, including age, BMI, vital signs, and laboratory results. In addition, sex and chronic comorbidities had lower predictive value than vital signs and laboratory results. InterpretationFor hospitalized adults, baseline data that is readily available within one hour after hospital admission or a first positive inpatient SARS-CoV-2 test can predict critical illness within one day, and up to 56 days later. Further, the relative importance of risk factors differs between older and younger patients.

4.
Preprint in English | medRxiv | ID: ppmedrxiv-20212803

ABSTRACT

BackgroundData on the characteristics of COVID-19 patients disaggregated by race/ethnicity remain limited. We evaluated the sociodemographic and clinical characteristics of patients across racial/ethnic groups and assessed their associations with COVID-19 outcomes. MethodsThis retrospective cohort study examined 629,953 patients tested for SARS-CoV-2 in a large health system spanning California, Oregon, and Washington between March 1 and December 31, 2020. Sociodemographic and clinical characteristics were obtained from electronic health records. Odds of SARS-CoV-2 infection, COVID-19 hospitalization, and in-hospital death were assessed with multivariate logistic regression. Results570,298 patients with known race/ethnicity were tested for SARS-CoV-2, of whom 27.8% were non-White minorities. 54,645 individuals tested positive, with minorities representing 50.1%. Hispanics represented 34.3% of infections but only 13.4% of tests. While generally younger than White patients, Hispanics had higher rates of diabetes but fewer other comorbidities. 8,536 patients were hospitalized and 1,246 died, of whom 56.1% and 54.4% were non-White, respectively. Racial/ethnic distributions of outcomes across the health system tracked with state-level statistics. Increased odds of testing positive and hospitalization were associated with all minority races/ethnicities. Hispanic patients also exhibited increased morbidity, and Hispanic race/ethnicity was associated with in-hospital mortality (OR: 1.39 [95% CI: 1.14-1.70]). ConclusionMajor healthcare disparities were evident, especially among Hispanics who tested positive at a higher rate, required excess hospitalization and mechanical ventilation, and had higher odds of in-hospital mortality despite younger age. Targeted, culturally-responsive interventions and equitable vaccine development and distribution are needed to address the increased risk of poorer COVID-19 outcomes among minority populations. Key pointsRacial/ethnic disparities are evident in the disaggregated characteristics of COVID-19 patients. Minority patients experience increased odds of SARS-CoV-2 infection and COVID-19 hospitalization. Hospitalized Hispanic patients presented with more severe illness, experienced increased morbidity, and faced increased mortality.

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