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1.
J Infect Dis ; 2021 Oct 07.
Article in English | MEDLINE | ID: covidwho-1455314

ABSTRACT

BACKGROUND: Evaluate pre-vaccine pandemic period COVID-19 death risk factors among nursing home (NH) residents. METHODS: Retrospective cohort study covering Medicare fee-for-service beneficiaries ages ≥65 residing in U.S. NHs. We estimated adjusted hazard ratios (HRs) using multivariate Cox proportional hazards regressions. RESULTS: Among 608,251 elderly NH residents, 57,398 (9.4%) died of COVID-related illness April 1 to December 22, 2020. About 46.9% (26,893) of these COVID-19 deaths occurred without prior COVID-19 hospitalizations. We observed a consistently increasing age trend for COVID-19 deaths. Racial/ethnic minorities generally shared a similarly high risk of NH COVID-19 deaths with Whites. NH facility characteristics including for-profit ownership and low health inspection ratings were associated with higher death risk. Resident characteristics, including male (HR 1.69), end-stage renal disease (HR 1.42), cognitive impairment (HR 1.34), and immunocompromised status (HR 1.20) were important death risk factors. Other individual-level characteristics were less predictive of death than they were in community-dwelling population. CONCLUSIONS: Low NH health inspection ratings and private ownership contributed to COVID-19 death risks. Nearly half of NH COVID-19 deaths occurred without prior COVID-19 hospitalization and older residents were less likely to get hospitalized with COVID-19. No substantial differences were observed by race/ethnicity and socioeconomic status for NH COVID-19 deaths.

2.
J Gen Intern Med ; 36(12): 3802-3809, 2021 12.
Article in English | MEDLINE | ID: covidwho-1446213

ABSTRACT

BACKGROUND: There are theoretical concerns that angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) could increase the risk of severe Covid-19. OBJECTIVE: To determine if ACEIs and ARBs are associated with an increased risk of Covid-19 hospitalization overall, or hospitalization involving intensive care unit (ICU) admission, invasive mechanical ventilation, or death. DESIGN: Observational case-control study. PARTICIPANTS: Medicare beneficiaries aged ≥ 66 years with hypertension, treated with ACEIs, ARBs, calcium channel blockers (CCBs), or thiazide diuretics. MAIN MEASURES: Adjusted odds ratios (OR) and 95% confidence intervals (CI) for the outcomes of Covid-19 hospitalization, or hospitalization involving ICU admission, invasive mechanical ventilation, or death. RESULTS: A total of 35,300 cases of hospitalized Covid-19 were matched to 228,228 controls on calendar date and neighborhood of residence. The median age of cases was 79 years, 57.4% were female, and the median duration of hospitalization was 8 days (interquartile range 5-12). ACEIs and ARBs were associated with a slight reduction in Covid-19 hospitalization risk compared with treatment with other first-line antihypertensives (OR for ACEIs 0.95, 95% CI 0.92-0.98; OR for ARBs 0.94, 95% CI 0.90-0.97). Similar results were obtained for hospitalizations involving ICU admission, invasive mechanical ventilation, or death. There were no meaningful differences in risk for ACEIs compared with ARBs. In an analysis restricted to monotherapy with a first-line agent, CCBs were associated with a small increased risk of Covid-19 hospitalization compared with ACEIs (OR 1.09, 95% CI 1.04-1.14), ARBs (OR 1.10, 95% CI 1.05-1.15), or thiazide diuretics (OR 1.11, 95% CI 1.03-1.19). CONCLUSIONS: ACEIs and ARBs were not associated with an increased risk of Covid-19 hospitalization or with hospitalization involving ICU admission, invasive mechanical ventilation, or death. The finding of a small increased risk of Covid-19 hospitalization with CCBs was unexpected and could be due to residual confounding.

3.
Vaccine ; 39(29): 3814-3824, 2021 06 29.
Article in English | MEDLINE | ID: covidwho-1253722

ABSTRACT

OBJECTIVE: This scoping review mapped studies using real-world data (RWD) to measure pediatric safety and effectiveness of vaccines administered to pregnant women. INTRODUCTION: In the US, two vaccines are recommended for all pregnant women to prevent illness in the infant: inactivated influenza vaccine (recommended since 2004), and the combined tetanus-diphtheria-acellular pertussis (Tdap) vaccine (recommended since 2013). This scoping review maps the studies conducted to date that address questions about pediatric safety and effectiveness of vaccines administered during pregnancy and provides a knowledge base for evaluating the use of RWD to study this issue. METHODS: The scoping review was conducted following a published protocol. Methods included an electronic search of PubMed and Embase, screening of titles and abstracts by two reviewers, and double extraction of data for summary and synthesis. Studies that reported on pregnant women and the effectiveness or safety outcomes in their infants were included. RESULTS: Forty-eight studies met the inclusion criteria of the scoping review protocol using RWD to assess safety or effectiveness of influenza or pertussis vaccinations administered to pregnant women with respect to pregnancy, infant or child outcomes. Detailed information about data sources, linkage of maternal and infant data, and operational definitions for gestational age were largely absent from the majority of studies raising concerns about reproducibility and validity of study findings. CONCLUSIONS: A body of literature is available from which to plan and design future studies of vaccination in pregnant women using RWD. This is of intense importance as new vaccines, such as those for COVID-19, become available to the general population via approval or authorization without inclusion of pregnant women in the clinical trials.


Subject(s)
COVID-19 , Diphtheria-Tetanus-acellular Pertussis Vaccines , Influenza Vaccines , Whooping Cough , Child , Female , Humans , Infant , Influenza Vaccines/adverse effects , Pregnancy , Pregnant Women , Reproducibility of Results , SARS-CoV-2 , Vaccination
4.
Vaccine ; 39(28): 3666-3677, 2021 06 23.
Article in English | MEDLINE | ID: covidwho-1230808

ABSTRACT

The Coronavirus Disease 2019 (COVID-19) pandemic has had a devastating impact on global health, and has resulted in an unprecedented, international collaborative effort to develop vaccines to control the outbreak, protect human lives, and avoid further social and economic disruption. Mass vaccination campaigns are underway in multiple countries and are expected worldwide once more vaccine becomes available. Some early candidate vaccines use novel platforms, such as mRNA encapsulated in lipid nanoparticles, and relatively new platforms, such as replication-deficient viral vectors. While these new vaccine platforms hold promise, limited safety data in humans are available. Serious health outcomes linked to vaccinations are rare, and some outcomes may occur incidentally in the vaccinated population. Knowledge of background incidence rates of these medical conditions is a critical component of vaccine safety monitoring to aid in the assessment of adverse events temporally associated with vaccination and to put these events into context with what would be expected due to chance alone. A list of 22 potential adverse events of special interest (AESI), including neurologic, autoimmune, and cardiovascular disorders, was compiled by subject matter experts at the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. The most recently available U.S. background rates for these medical conditions, overall and by age, sex, and race/ethnicity (when available), were sourced from reported statistics (data published by medical panels/ associations or federal government reports), and literature reviews in PubMed. This review provides estimates of background incidence rates for medical conditions that may be monitored or studied as AESI during safety surveillance and research for COVID-19 vaccines and other new vaccines.


Subject(s)
COVID-19 , Vaccines , COVID-19 Vaccines , Humans , Incidence , SARS-CoV-2 , United States/epidemiology , Vaccination , Vaccines/adverse effects
5.
J Infect Dis ; 223(6): 945-956, 2021 03 29.
Article in English | MEDLINE | ID: covidwho-1155781

ABSTRACT

BACKGROUND: The current study was performed to evaluate risk factors for severe coronavirus disease 2019 (COVID-19) outcomes among Medicare beneficiaries during the pandemic's early phase. METHODS: In a retrospective cohort study covering Medicare fee-for-service beneficiaries, we separated out elderly residents in nursing homes (NHs) and those with end-stage renal disease (ESRD) from the primary study population of individuals age ≥65 years. Outcomes included COVID-19 hospital encounters and COVID-19-associated deaths. We estimated adjusted odds ratios (ORs) using logistic regression. RESULTS: We analyzed 25 333 329 elderly non-NH beneficiaries without ESRD, 653 966 elderly NH residents, and 292 302 patients with ESRD. COVID-related death rates (per 10 000) were much higher among elderly NH residents (275.7) and patients with ESRD (60.8) than in the primary study population (5.0). Regression-adjusted clinical predictors of death among the primary population included immunocompromised status (OR, 1.43), frailty index conditions such as cognitive impairment (3.16), and other comorbid conditions, including congestive heart failure (1.30). Demographic-related risk factors included male sex (OR, 1.77), older age (3.09 for 80- vs 65-year-olds), Medicaid dual-eligibility status (2.17), and racial/ethnic minority. Compared with whites, ORs were higher for blacks (2.47), Hispanics (3.11), and Native Americans (5.82). Results for COVID-19 hospital encounters were consistent. CONCLUSIONS: Frailty, comorbid conditions, and race/ethnicity were strong risk factors for COVID-19 hospitalization and death among the US elderly.


Subject(s)
COVID-19/mortality , Medicare/statistics & numerical data , Aged , Aged, 80 and over , Female , Hospitalization/statistics & numerical data , Humans , Male , Minority Groups , Nursing Homes , Pandemics , Retrospective Studies , Risk Factors , SARS-CoV-2/isolation & purification , Severity of Illness Index , United States/epidemiology
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