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"Fleming-Dutra, Katherine E"
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Early Estimates of Updated 2023–2024 (Monovalent XBB.1.5) COVID-19 Vaccine Effectiveness Against Symptomatic SARS-CoV-2 Infection Attributable to Co-Circulating Omicron Variants Among Immunocompetent Adults — Increasing Community Access to Testing Program, United States, September 2023–January 2024
2024
On September 12, 2023, CDC's Advisory Committee on Immunization Practices recommended updated 2023-2024 (updated) COVID-19 vaccination with a monovalent XBB.1.5-derived vaccine for all persons aged ≥6 months to prevent COVID-19, including severe disease. During fall 2023, XBB lineages co-circulated with JN.1, an Omicron BA.2.86 lineage that emerged in September 2023. These variants have amino acid substitutions that might increase escape from neutralizing antibodies. XBB lineages predominated through December 2023, when JN.1 became predominant in the United States. Reduction or failure of spike gene (S-gene) amplification (i.e., S-gene target failure [SGTF]) in real-time reverse transcription-polymerase chain reaction testing is a time-dependent, proxy indicator of JN.1 infection. Data from the Increasing Community Access to Testing SARS-CoV-2 pharmacy testing program were analyzed to estimate updated COVID-19 vaccine effectiveness (VE) (i.e., receipt versus no receipt of updated vaccination) against symptomatic SARS-CoV-2 infection, including by SGTF result. Among 9,222 total eligible tests, overall VE among adults aged ≥18 years was 54% (95% CI = 46%-60%) at a median of 52 days after vaccination. Among 2,199 tests performed at a laboratory with SGTF testing, VE 60-119 days after vaccination was 49% (95% CI = 19%-68%) among tests exhibiting SGTF and 60% (95% CI = 35%-75%) among tests without SGTF. Updated COVID-19 vaccines provide protection against symptomatic infection, including against currently circulating lineages. CDC will continue monitoring VE, including for expected waning and against severe disease. All persons aged ≥6 months should receive an updated COVID-19 vaccine dose.
Journal Article
Effectiveness of Bivalent mRNA Vaccines in Preventing Symptomatic SARS‐CoV‐2 Infection—Increasing Community Access to Testing Program, United States, January–September 2023
2024
Background On September 2, 2022, bivalent COVID‐19 mRNA vaccines, were recommended to address reduced effectiveness of COVID‐19 monovalent vaccines during SARS‐CoV‐2 Omicron variant predominance. Methods Using national pharmacy‐based SARS‐CoV‐2 testing program data from January 15 to September 11, 2023, this test‐negative, case–control design study assessed bivalent COVID‐19 vaccine effectiveness (VE) against symptomatic infection. Results VE against symptomatic infection of a bivalent dose between 2 weeks and 1 month after bivalent vaccination ranged from 46% (95% CI: 38%–52%) for those aged ≥ 65 years to 61% (95% CI 41%–75%) for those aged 12–17 years. Conclusion Bivalent vaccines protected against symptomatic infection. However, effectiveness waned over time, emphasizing the need to stay up to date with COVID‐19 vaccination.
Journal Article
Advances in optimizing the prescription of antibiotics in outpatient settings
by
Fleming-Dutra, Katherine E
,
King, Laura M
,
Hicks, Lauri A
in
Anti-Bacterial Agents - supply & distribution
,
Antibiotic resistance
,
Antibiotics
2018
The inappropriate use of antibiotics can increase the likelihood of antibiotic resistance and adverse events. In the United States, nearly a third of antibiotic prescriptions in outpatient settings are unnecessary, and the selection of antibiotics and duration of treatment are also often inappropriate. Evidence shows that antibiotic prescribing is influenced by psychosocial factors, including lack of accountability, perceived patient expectations, clinician workload, and habit. A varied and growing body of evidence, including meta-analyses and randomized controlled trials, has evaluated interventions to optimize the use of antibiotics. Interventions informed by behavioral science—such as communication skills training, audit and feedback with peer comparison, public commitment posters, and accountable justification—have been associated with improved antibiotic prescribing. In addition, delayed prescribing, active monitoring, and the use of diagnostics are guideline recommended practices that improve antibiotic use for some conditions. In 2016, the Centers for Disease Control and Prevention released the Core Elements of Outpatient Antibiotic Stewardship , which provides a framework for implementing these interventions in outpatient settings. This review summarizes the varied evidence on drivers of inappropriate prescription of antibiotics in outpatient settings and potential interventions to improve their use in such settings.
Journal Article
Effectiveness of Bivalent mRNA Vaccines in Preventing Symptomatic SARS-CoV-2 Infection — Increasing Community Access to Testing Program, United States, September–November 2022
by
Fleming-Dutra, Katherine E.
,
Schrag, Stephanie J.
,
Verani, Jennifer R.
in
Adolescent
,
Adult
,
Age groups
2022
On September 1, 2022, bivalent COVID-19 mRNA vaccines, composed of components from the SARS-CoV-2 ancestral and Omicron BA.4/BA.5 strains, were recommended by the Advisory Committee on Immunization Practices (ACIP) to address reduced effectiveness of COVID-19 monovalent vaccines during SARS-CoV-2 Omicron variant predominance (1). Initial recommendations included persons aged ≥12 years (Pfizer-BioNTech) and ≥18 years (Moderna) who had completed at least a primary series of any Food and Drug Administration-authorized or -approved monovalent vaccine ≥2 months earlier (1). On October 12, 2022, the recommendation was expanded to include children aged 5-11 years. At the time of recommendation, immunogenicity data were available from clinical trials of bivalent vaccines composed of ancestral and Omicron BA.1 strains; however, no clinical efficacy data were available. In this study, effectiveness of the bivalent (Omicron BA.4/BA.5-containing) booster formulation against symptomatic SARS-CoV-2 infection was examined using data from the Increasing Community Access to Testing (ICATT) national SARS-CoV-2 testing program.* During September 14-November 11, 2022, a total of 360,626 nucleic acid amplification tests (NAATs) performed at 9,995 retail pharmacies for adults aged ≥18 years, who reported symptoms consistent with COVID-19 at the time of testing and no immunocompromising conditions, were included in the analysis. Relative vaccine effectiveness (rVE) of a bivalent booster dose compared with that of ≥2 monovalent vaccine doses among persons for whom 2-3 months and ≥8 months had elapsed since last monovalent dose was 30% and 56% among persons aged 18-49 years, 31% and 48% among persons aged 50-64 years, and 28% and 43% among persons aged ≥65 years, respectively. Bivalent mRNA booster doses provide additional protection against symptomatic SARS-CoV-2 in immunocompetent persons who previously received monovalent vaccine only, with relative benefits increasing with time since receipt of the most recent monovalent vaccine dose. Staying up to date with COVID-19 vaccination, including getting a bivalent booster dose when eligible, is critical to maximizing protection against COVID-19 (1).
Journal Article
Vaccine Effectiveness against SARS-CoV-2 Variant P.1 in Nursing-Facility Residents, Washington, USA, April 2021
2022
A SARS-CoV-2 P.1 (Gamma) variant outbreak occurred at a skilled nursing facility in Washington, USA, in April 2021. Effectiveness of 2 doses of mRNA vaccines against P.1 infection among residents in this outbreak was 75.0% (95% CI 44.5%-88.7%), similar to effectiveness for other pre-Delta variants among long-term care residents.
Journal Article
Core Elements of Outpatient Antibiotic Stewardship
by
Hicks, Lauri A.
,
Fleming-Dutra, Katherine E.
,
Sanchez, Guillermo V.
in
Ambulatory Care Facilities
,
Anti-Bacterial Agents - therapeutic use
,
Antibiotics
2016
The Core Elements of Outpatient Antibiotic Stewardship provides a framework for antibiotic stewardship for outpatient clinicians and facilities that routinely provide antibiotic treatment. This report augments existing guidance for other clinical settings. In 2014 and 2015, respectively, CDC released the Core Elements of Hospital Antibiotic Stewardship Programs and the Core Elements of Antibiotic Stewardship for Nursing Homes. Antibiotic stewardship is the effort to measure and improve how antibiotics are prescribed by clinicians and used by patients. Improving antibiotic prescribing involves implementing effective strategies to modify prescribing practices to align them with evidence-based recommendations for diagnosis and management. The four core elements of outpatient antibiotic stewardship are commitment, action for policy and practice, tracking and reporting, and education and expertise. Outpatient clinicians and facility leaders can commit to improving antibiotic prescribing and take action by implementing at least one policy or practice aimed at improving antibiotic prescribing practices. Clinicians and leaders of outpatient clinics and health care systems can track antibiotic prescribing practices and regularly report these data back to clinicians. Clinicians can provide educational resources to patients and families on appropriate antibiotic use. Finally, leaders of outpatient clinics and health systems can provide clinicians with education aimed at improving antibiotic prescribing and with access to persons with expertise in antibiotic stewardship. Establishing effective antibiotic stewardship interventions can protect patients and improve clinical outcomes in outpatient health care settings.
Journal Article
How to Prescribe Fewer Unnecessary Antibiotics: Talking Points That Work with Patients and Their Families
by
Mangione-Smith, Rita, MD, MPH
,
Hicks, Lauri A., DO
,
Fleming-Dutra, Katherine E., MD
in
Anti-Bacterial Agents - therapeutic use
,
Communication
,
Drug Resistance, Microbial
2016
Journal Article
Building the U.S. COVID-19 vaccine effectiveness program: Past successes and future directions
by
Fleming-Dutra, Katherine E.
,
Britton, Amadea
,
Link-Gelles, Ruth
in
Allergy and Immunology
,
Centers for Disease Control and Prevention, U.S
,
Clinical trials
2024
COVID-19 vaccines were originally authorized in the United States in December 2020 on the basis of safety, immunogenicity, and clinical efficacy data from randomized controlled trials (RCTs). However, real-world vaccine effectiveness (VE) data are necessary to provide information on how the vaccines work in populations not included in the RCTs (e.g., nursing home residents), against new SARS-CoV-2 variants, with increasing time since vaccination, and in populations with increasing levels of prior infection. The goal of CDC’s COVID-19 VE program is to provide timely and robust data to support ongoing policy decisions and implementation of vaccination and includes VE platforms to study the spectrum of illness, from infection to critical illness. Challenges to estimating VE include accurate ascertainment of vaccination history, outcome status, changing rates of prior infection, emergence of new variants, and appropriate interpretation of absolute and relative VE measures. CDC COVID-19 VE platforms have played a pivotal role in numerous vaccine policy decisions since 2021 and will continue to play a key role in future decisions as the vaccine program moves from an emergency response to a routine schedule.
Journal Article
Opportunities to Improve Fluoroquinolone Prescribing in the United States for Adult Ambulatory Care Visits
by
Fleming-Dutra, Katherine E
,
Kabbani, Sarah
,
Pavia, Andrew T
in
Ambulatory care
,
Antibiotics
,
Brief Reports
2018
Abstract
The Food and Drug Administration warned against fluoroquinolone use for conditions with effective alternative agents. An estimated 5.1% of adult ambulatory fluoroquinolone prescriptions were for conditions that did not require antibiotics, and 19.9% were for conditions where fluoroquinolones are not recommended first-line therapy. Unnecessary fluoroquinolone use should be reduced.
Journal Article
Effectiveness of Homologous and Heterologous Covid-19 Boosters against Omicron
by
Britton, Amadea
,
Smith, Zachary R.
,
Fleming-Dutra, Katherine E.
in
Age groups
,
Confidence intervals
,
Coronavirus
2022
Among persons vaccinated with the adenovirus-based vaccine who received a booster dose of an mRNA vaccine, protection against the omicron variant was assessed. A single booster dose of an mRNA vaccine in recipients of a single priming dose of Ad26.COV2.S provided protection close to that of a three-dose mRNA vaccine regimen.
Journal Article