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Article ; Online: Building the U.S. COVID-19 vaccine effectiveness program: Past successes and future directions.

Link-Gelles, Ruth / Britton, Amadea / Fleming-Dutra, Katherine E

2023

Abstract: 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 ... ...

Abstract	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.
Language	English
Publishing date	2023-12-20
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.12.002
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Article ; Online: Messenger RNA Vaccine in Mother's Milk.

Nelson, Jennifer M / Fleming-Dutra, Katherine E / Meaney-Delman, Dana

JAMA pediatrics

2023 Volume 177, Issue 4, Page(s) 438–439

MeSH term(s)	Female ; Humans ; Mothers ; RNA, Messenger ; Milk, Human ; Breast Feeding
Chemical Substances	RNA, Messenger
Language	English
Publishing date	2023-02-18
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	2701223-2
ISSN	2168-6211 ; 2168-6203
ISSN (online)	2168-6211
ISSN	2168-6203
DOI	10.1001/jamapediatrics.2022.6024
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Article ; Online: Rightsizing Treatment for Pneumonia in Children.

Tsay, Sharon V / Hersh, Adam L / Fleming-Dutra, Katherine E

JAMA pediatrics

2021 Volume 175, Issue 5, Page(s) 462–463

MeSH term(s)	Child ; Humans ; Personnel Downsizing ; Pneumonia
Language	English
Publishing date	2021-04-05
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	2701223-2
ISSN	2168-6211 ; 2168-6203
ISSN (online)	2168-6211
ISSN	2168-6203
DOI	10.1001/jamapediatrics.2020.6743
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Article ; Online: Comparison of outpatient antibiotic prescriptions among older adults in IQVIA Xponent and publicly available Medicare Part D data, 2018.

Beshearse, Elizabeth M / Gouin, Katryna A / Fleming-Dutra, Katherine E / Tsay, Sharon / Hicks, Lauri A / Kabbani, Sarah

Antimicrobial stewardship & healthcare epidemiology : ASHE

2023 Volume 3, Issue 1, Page(s) e32

Abstract: The distributions of antibiotic prescriptions by geography, antibiotic class, and prescriber specialty are similar in the US Centers for Medicare and Medicaid Services (CMS) Part D Prescriber Public Use Files and IQVIA Xponent dataset. Public health ... ...

Abstract	The distributions of antibiotic prescriptions by geography, antibiotic class, and prescriber specialty are similar in the US Centers for Medicare and Medicaid Services (CMS) Part D Prescriber Public Use Files and IQVIA Xponent dataset. Public health organizations and healthcare systems can use these data to track antibiotic use and guide antibiotic stewardship interventions for older adults.
Language	English
Publishing date	2023-02-15
Publishing country	England
Document type	Journal Article
ISSN	2732-494X
ISSN (online)	2732-494X
DOI	10.1017/ash.2022.332
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Article ; Online: 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.

Link-Gelles, Ruth / Ciesla, Allison Avrich / Mak, Josephine / Miller, Joseph D / Silk, Benjamin J / Lambrou, Anastasia S / Paden, Clinton R / Shirk, Philip / Britton, Amadea / Smith, Zachary R / Fleming-Dutra, Katherine E

MMWR. Morbidity and mortality weekly report

2024 Volume 73, Issue 4, Page(s) 77–83

Abstract: 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. ...

Abstract	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.
MeSH term(s)	United States/epidemiology ; Adult ; Humans ; Adolescent ; COVID-19 Vaccines ; COVID-19/diagnosis ; COVID-19/epidemiology ; COVID-19/prevention & control ; Vaccine Efficacy ; SARS-CoV-2
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2024-02-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	412775-4
ISSN	1545-861X ; 0149-2195
ISSN (online)	1545-861X
ISSN	0149-2195
DOI	10.15585/mmwr.mm7304a2
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Article ; Online: Administration of the GSK Respiratory Syncytial Virus Vaccine to Pregnant Persons in Error.

Moro, Pedro L / Gallego, Ruth / Scheffey, Anne / Fleming-Dutra, Katherine E / Hall, Elisha / Zhang, Bicheng / Marquez, Paige / Jones, Jefferson M / Nair, Narayan / Broder, Karen R

Obstetrics and gynecology

2024 Volume 143, Issue 5, Page(s) 704–706

Abstract: The GSK and Pfizer respiratory syncytial virus (RSV) vaccines are both indicated for adults aged 60 years and older, but only the Pfizer product is approved for use in pregnancy to prevent RSV-associated lower respiratory tract disease in infants aged ... ...

Abstract	The GSK and Pfizer respiratory syncytial virus (RSV) vaccines are both indicated for adults aged 60 years and older, but only the Pfizer product is approved for use in pregnancy to prevent RSV-associated lower respiratory tract disease in infants aged younger than 6 months. To assess for vaccine administration errors (ie, administration of the GSK RSV vaccine to pregnant persons) VAERS (Vaccine Adverse Event Reporting System), a U.S. passive reporting system, was searched for the time period from August 2023 to January 2024. A total of 113 reports of these administration errors were identified. Most reports (103, 91.2%) did not describe an adverse event. These administration errors are preventable with proper education and training and other preventive measures.
MeSH term(s)	Adult ; Female ; Humans ; Pregnancy ; Respiratory Syncytial Virus Infections/prevention & control ; Respiratory Syncytial Virus Infections/chemically induced ; Respiratory Syncytial Virus Vaccines/adverse effects ; Vaccination ; Medical Errors
Chemical Substances	Respiratory Syncytial Virus Vaccines
Language	English
Publishing date	2024-02-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	207330-4
ISSN	1873-233X ; 0029-7844
ISSN (online)	1873-233X
ISSN	0029-7844
DOI	10.1097/AOG.0000000000005551
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Article ; Online: Use of an Additional Updated 2023-2024 COVID-19 Vaccine Dose for Adults Aged ≥65 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024.

Panagiotakopoulos, Lakshmi / Godfrey, Monica / Moulia, Danielle L / Link-Gelles, Ruth / Taylor, Christopher A / Chatham-Stephens, Kevin / Brooks, Oliver / Daley, Matthew F / Fleming-Dutra, Katherine E / Wallace, Megan

MMWR. Morbidity and mortality weekly report

2024 Volume 73, Issue 16, Page(s) 377–381

Abstract: COVID-19 remains an important public health threat, despite overall decreases in COVID-19-related severe disease since the start of the COVID-19 pandemic. COVID-19-associated hospitalization rates remain higher among adults aged ≥65 years relative to ... ...

Abstract	COVID-19 remains an important public health threat, despite overall decreases in COVID-19-related severe disease since the start of the COVID-19 pandemic. COVID-19-associated hospitalization rates remain higher among adults aged ≥65 years relative to rates in younger adults, adolescents, and children; during October 2023-January 2024, 67% of all COVID-19-associated hospitalizations were among persons aged ≥65 years. On September 12, 2023, CDC's Advisory Committee on Immunization Practices (ACIP) recommended updated (2023-2024 Formula) COVID-19 vaccination with a monovalent XBB.1.5-derived vaccine for all persons aged ≥6 months to protect against severe COVID-19-associated illness and death. Because SARS-CoV-2 continues to circulate throughout the year, and because of the increased risk for COVID-19-related severe illness in persons aged ≥65 years, the protection afforded by updated vaccines against JN.1 and other currently circulating variants, and the expected waning of vaccine-conferred protection against disease, on February 28, 2024, ACIP recommended all persons aged ≥65 years receive 1 additional dose of the updated (2023-2024 Formula) COVID-19 vaccine. Implementation of these recommendations is expected to enhance immunity that might have waned and decrease the risk for severe COVID-19-associated outcomes, including death, among persons aged ≥65 years.
MeSH term(s)	Humans ; United States/epidemiology ; Aged ; COVID-19 Vaccines/administration & dosage ; Advisory Committees ; COVID-19/prevention & control ; COVID-19/epidemiology ; Centers for Disease Control and Prevention, U.S. ; Immunization Schedule ; Practice Guidelines as Topic
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2024-04-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	412775-4
ISSN	1545-861X ; 0149-2195
ISSN (online)	1545-861X
ISSN	0149-2195
DOI	10.15585/mmwr.mm7316a4
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Article ; Online: Pediatric Urgent Care Providers' Approach to Antibiotic Stewardship: A National Survey.

Hamdy, Rana F / Nedved, Amanda / Fung, Melody / Fleming-Dutra, Katherine E / Liu, Cindy M / Obremskey, Jill / Montalbano, Amanda

Pediatric emergency care

2022 Volume 38, Issue 8, Page(s) e1446–e1448

Abstract: Background: Outpatient antibiotic prescribing for acute respiratory conditions is highest in urgent care settings; however, this has not been studied among pediatric urgent cares. The objective of this study was to evaluate pediatric urgent care ... ...

Abstract	Background: Outpatient antibiotic prescribing for acute respiratory conditions is highest in urgent care settings; however, this has not been studied among pediatric urgent cares. The objective of this study was to evaluate pediatric urgent care providers' perceptions of antibiotic stewardship. Methods: Members of the Society for Pediatric Urgent Care were recruited via email to participate in a quality improvement antibiotic stewardship project. A preimplementation survey was sent to participants via email in March 2019 to evaluate perceptions on antibiotic stewardship. Descriptive statistics were used to analyze the survey responses. Results: A total of 156 providers completed the survey; 83% were board-certified pediatricians. Almost all (98%) indicated that antibiotic stewardship interventions are important for optimizing antibiotic use in urgent care. More than half (53%) indicated that their urgent care provided guidelines for prescribing antibiotics for acute respiratory tract infections. Treating patients with an underlying complex medical condition was the most common reason (21%) providers would deviate from guidelines. The most commonly cited barriers to appropriate prescribing for acute respiratory infections were patient expectations (93%), psychosocial barriers (40%), lack of clear evidence-based recommendations (15%), and lack of access to guidelines on prescribing (15%). Conclusions: Parental expectation of receiving antibiotics was viewed as the most common barrier to appropriate prescribing. These findings should be used to target directed interventions such as shared decision making and communication training to support appropriate antibiotic prescribing in pediatric urgent care.
MeSH term(s)	Ambulatory Care ; Anti-Bacterial Agents/therapeutic use ; Antimicrobial Stewardship ; Child ; Humans ; Inappropriate Prescribing/prevention & control ; Pediatricians ; Practice Patterns, Physicians' ; Respiratory Tract Infections/drug therapy
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2022-06-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	632588-9
ISSN	1535-1815 ; 0749-5161
ISSN (online)	1535-1815
ISSN	0749-5161
DOI	10.1097/PEC.0000000000002788
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Article ; Online: Identifying Higher-Volume Antibiotic Outpatient Prescribers Using Publicly Available Medicare Part D Data - United States, 2019.

Gouin, Katryna A / Fleming-Dutra, Katherine E / Tsay, Sharon / Bizune, Destani / Hicks, Lauri A / Kabbani, Sarah

MMWR. Morbidity and mortality weekly report

2022 Volume 71, Issue 6, Page(s) 202–205

Abstract: Antibiotic prescribing can lead to adverse drug events and antibiotic resistance, which pose ongoing urgent public health threats (1). Adults aged ≥65 years (older adults) are recipients of the highest rates of outpatient antibiotic prescribing and are ... ...

Abstract	Antibiotic prescribing can lead to adverse drug events and antibiotic resistance, which pose ongoing urgent public health threats (1). Adults aged ≥65 years (older adults) are recipients of the highest rates of outpatient antibiotic prescribing and are at increased risk for antibiotic-related adverse events, including Clostridioides difficile and antibiotic-resistant infections and related deaths (1). Variation in antibiotic prescribing quality is primarily driven by prescribing patterns of individual health care providers, independent of patients' underlying comorbidities and diagnoses (2). Engaging higher-volume prescribers (the top 10% of prescribers by antibiotic volume) in antibiotic stewardship interventions, such as peer comparison audit and feedback in which health care providers receive data on their prescribing performance compared with that of other health care providers, has been effective in reducing antibiotic prescribing in outpatient settings and can be implemented on a large scale (3-5). This study analyzed data from the Centers for Medicare & Medicaid Services (CMS) Part D Prescriber Public Use Files (PUFs)* to describe higher-volume antibiotic prescribers in outpatient settings compared with lower-volume prescribers (the lower 90% of prescribers by antibiotic volume). Among the 59.4 million antibiotic prescriptions during 2019, 41% (24.4 million) were prescribed by the top 10% of prescribers (69,835). The antibiotic prescribing rate of these higher-volume prescribers (680 prescriptions per 1,000 beneficiaries) was 60% higher than that of lower-volume prescribers (426 prescriptions per 1,000 beneficiaries). Identifying health care providers responsible for a higher volume of antibiotic prescribing could provide a basis for additional assessment of appropriateness and outreach. Public health organizations and health care systems can use publicly available data to guide focused interventions to optimize antibiotic prescribing to limit the emergence of antibiotic resistance and improve patient outcomes.
MeSH term(s)	Anti-Bacterial Agents/therapeutic use ; Drug Prescriptions/statistics & numerical data ; Humans ; Medicare Part D ; Outpatients ; Practice Patterns, Physicians'/statistics & numerical data ; United States
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2022-02-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	412775-4
ISSN	1545-861X ; 0149-2195
ISSN (online)	1545-861X
ISSN	0149-2195
DOI	10.15585/mmwr.mm7106a3
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Article ; Online: A Multisite Collaborative to Decrease Inappropriate Antibiotics in Urgent Care Centers.

Nedved, Amanda / Fung, Melody / Bizune, Destani / Liu, Cindy M / Obremskey, Jill / Fleming-Dutra, Katherine E / Hamdy, Rana F / Montalbano, Amanda

Pediatrics

2022 Volume 150, Issue 1

Abstract: Background: Urgent care (UC; a convenient site to receive care for ambulatory-sensitive) centers conditions; however, UC clinicians showed the highest rate of inappropriate antibiotic prescriptions among outpatient settings according to national billing ...

Abstract	Background: Urgent care (UC; a convenient site to receive care for ambulatory-sensitive) centers conditions; however, UC clinicians showed the highest rate of inappropriate antibiotic prescriptions among outpatient settings according to national billing data. Antibiotic prescribing practices in pediatric-specific UC centers were not known but assumed to require improvement. The aim of this multisite quality improvement project was to reduce inappropriate antibiotic prescribing practices for 3 target diagnoses in pediatric UC centers by a relative 20% by December 1, 2019. Methods: The Society of Pediatric Urgent Care invited pediatric UC clinicians to participate in a multisite quality improvement study from June 2019 to December 2019. The diagnoses included acute otitis media (AOM), otitis media with effusion, and pharyngitis. Algorithms based on published guidelines were used to identify inappropriate antibiotic prescriptions according to indication, agent, and duration. Sites completed multiple intervention cycles from a menu of publicly available antibiotic stewardship materials. Participants submitted data electronically. The outcome measure was the percentage of inappropriate antibiotic prescriptions for the target diagnoses. Process measures were use of delayed antibiotics for AOM and inappropriate testing in pharyngitis. Results: From 20 UC centers, 157 providers submitted data from 3833 encounters during the intervention cycles. Overall inappropriate antibiotic prescription rates decreased by a relative 53.9%. Inappropriate antibiotic prescribing decreased from 57.0% to 36.6% for AOM, 54.6% to 48.4% for otitis media with effusion, and 66.9% to 11.7% for pharyngitis. Conclusions: Participating pediatric UC providers decreased inappropriate antibiotic prescriptions from 60.3% to 27.8% using publicly available interventions.
MeSH term(s)	Ambulatory Care Facilities ; Anti-Bacterial Agents/therapeutic use ; Child ; Humans ; Inappropriate Prescribing/prevention & control ; Otitis Media/drug therapy ; Otitis Media with Effusion ; Pharyngitis/drug therapy ; Practice Patterns, Physicians' ; Respiratory Tract Infections/drug therapy
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2022-06-07
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	207677-9
ISSN	1098-4275 ; 0031-4005
ISSN (online)	1098-4275
ISSN	0031-4005
DOI	10.1542/peds.2021-051806
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