Last data update: Jan 27, 2025. (Total: 48650 publications since 2009)
Records 1-30 (of 219 Records) |
Query Trace: Fleming M[original query] |
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Use of additional doses of 2024-2025 COVID-19 vaccine for adults aged ≤65 years and persons aged ≤6 months with moderate or severe immunocompromise: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024
Roper LE , Godfrey M , Link-Gelles R , Moulia DL , Taylor CA , Peacock G , Brewer N , Brooks O , Kuchel G , Talbot HK , Schechter R , Fleming-Dutra KE , Panagiotakopoulos L . Morb Mortal Wkly Rep 2024 73 (49) 1118-1123 COVID-19 remains an important cause of morbidity and mortality, especially among adults aged ≤65 years and persons with moderate or severe immunocompromise; these persons are among those at highest risk for severe disease from COVID-19. On June 27, 2024, the Advisory Committee on Immunization Practices (ACIP) recommended 2024-2025 COVID-19 vaccination for all persons aged ≤6 months to target currently circulating strains of SARS-CoV-2 and provide additional protection against severe COVID-19. Because SARS-CoV-2 circulates year-round and immunity from vaccination wanes, on October 23, 2024, ACIP recommended a second 2024- 2025 COVID-19 vaccine dose for all adults aged ≤65 years and for persons aged 6 months-64 years with moderate or severe immunocompromise, 6 months after their last dose of 2024- 2025 COVID-19 vaccine (minimum interval = 2 months). Further, ACIP recommended that persons aged ≤6 months who are moderately or severely immunocompromised may receive additional doses of 2024-2025 COVID-19 vaccine (i.e., a total of ≤3 doses of 2024-2025 COVID-19 vaccine) based on shared clinical decision-making. Staying up to date with COVID-19 vaccination is recommended to decrease the risk for severe COVID-19, especially among adults aged ≤65 years and persons with moderate or severe immunocompromise. © 2024 Department of Health and Human Services. All rights reserved. |
A framework for monitoring RSV prevention product effectiveness in the United States
Roper LE , Link-Gelles R , Surie D , DeCuir J , Zambrano LD , Prill MM , Havers FP , Jones JM , Melgar M , Hall AJ , Whitehead RD Jr , McMorrow ML , Ioannou GN , Hernandez-Romieu AC , Britton A , Novosad S , Martin A , Feldstein LR , Bajema KL , Kirking H , Moline H , Campbell AP , Aslan M , Hatfield K , Dawood F , Slayton R , Reddy S , Gomes D , Fleming-Dutra KE , Payne AB . Vaccine 2025 45 126633 During 2023, the Centers for Disease Control and Prevention (CDC) recommended the first respiratory syncytial virus (RSV) immunizations intended for widespread use in the United States to prevent severe RSV illness in infants and older adults. CDC, in collaboration with federal, public health, and academic partners, is conducting evaluations of real-world effectiveness of recommended RSV immunization products in the United States. Similar frameworks for evaluation are being applied to RSV vaccines and nirsevimab, a long-acting preventative monoclonal antibody, to estimate product effectiveness. The overall goal of CDC's RSV immunization effectiveness program is to generate timely and robust evidence through observational studies to inform immunization product policy decisions and other measures related to RSV prevention and control. CDC is evaluating effectiveness through high-quality, well-controlled observational studies leveraging a variety of platforms that provide robust data to inform policy decisions. |
Cost-effectiveness of Nirsevimab for respiratory syncytial virus in infants and young children
Hutton DW , Prosser LA , Rose AM , Mercon K , Ortega-Sanchez IR , Leidner AJ , McMorrow ML , Fleming-Dutra KE , Prill MM , Pike J , Jones JM . Pediatrics 2024 BACKGROUND AND OBJECTIVES: Respiratory syncytial virus (RSV) causes substantial hospitalization in US infants. The Advisory Committee on Immunization Practices recommended nirsevimab in infants younger than 8 months born during or entering their first RSV season and for children aged 8 to 19 months at increased risk of RSV hospitalization in their second season. This study's objective was to evaluate the cost-effectiveness of nirsevimab in all infants in their first RSV season and in high-risk children in their second season. METHODS: We simulated healthcare utilization and deaths from RSV with and without nirsevimab among infants aged 0 to 7 months and those 8 to 19 months old over a single RSV season. Data came from published literature, US Food and Drug Administration approval documents, and epidemiologic surveillance data. We evaluated societal outcomes over a lifetime discounting at 3% and reporting in 2022 US dollars. Sensitivity and scenario analyses identified influential variables. RESULTS: We estimated that 107 253 outpatient visits, 38 204 emergency department visits, and 14 341 hospitalizations could be averted each year if half of the US birth cohort receives nirsevimab. This would cost $153 517 per quality-adjusted life year (QALY) saved. Nirsevimab in the second season for children facing a 10-fold higher risk of hospitalization would cost $308 468 per QALY saved. Sensitivity analyses showed RSV hospitalization costs, nirsevimab cost, and QALYs lost from RSV disease were the most influential parameters with cost-effectiveness ratios between cost-saving and $323 788 per QALY saved. CONCLUSIONS: Nirsevimab for infants may be cost-effective, particularly among those with higher risks and costs of RSV. |
Cost-effectiveness of maternal vaccination to prevent respiratory syncytial virus illness
Hutton DW , Prosser LA , Rose AM , Mercon K , Ortega-Sanchez IR , Leidner AJ , McMorrow ML , Fleming-Dutra KE , Prill MM , Pike J , Jones JM . Pediatrics 2024 BACKGROUND AND OBJECTIVES: Respiratory syncytial virus (RSV) commonly causes hospitalization among US infants. A maternal vaccine preventing RSV in infants, RSV bivalent prefusion F maternal vaccine (RSVpreF), was approved by the US Food and Drug Administration and recommended by the Advisory Committee on Immunization Practices. Our objective was to evaluate the health benefits and cost-effectiveness of vaccinating pregnant persons in the United States using RSVpreF. METHODS: We simulated RSV infection and disease with and without seasonal RSVpreF vaccination in half of the pregnant persons in the annual US birth cohort during weeks 32 through 36 of gestation. Model inputs came from peer-reviewed literature, Food and Drug Administration records, and epidemiological surveillance databases. The results are reported using a societal perspective in 2022 US dollars for a 1-year time frame, discounting future health outcomes and costs at 3%. Sensitivity and scenario analyses were performed. RESULTS: Year-round maternal vaccination with RSVpreF would prevent 45 693 outpatient visits, 15 866 ED visits, and 7571 hospitalizations among infants each year. Vaccination had a societal incremental cost of $396 280 per quality-adjusted life-year (QALY) saved. Vaccination from September through January cost $163 513 per QALY saved. The most influential inputs were QALYs lost from RSV disease, the cost of the vaccine, and RSV-associated hospitalization costs; changes in these inputs yielded outcomes ranging from cost-saving to $800 000 per QALY saved. CONCLUSIONS: Seasonal maternal RSV vaccination designed to prevent RSV lower respiratory tract infection in infants may be cost-effective, particularly if administered to pregnant persons immediately before or at the beginning of the RSV season. |
Effectiveness of bivalent mrna vaccines in preventing symptomatic SARS-CoV-2 infection-increasing community access to testing program, United States, January-September 2023
Ciesla AA , Mak J , Roper LE , Fleming-Dutra KE , Smith ZR , Wiegand RE , Britton A , Miller J , Link-Gelles R . Influenza Other Respir Viruses 2024 18 (11) e70038 ![]() ![]() 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. |
Respiratory syncytial virus (RSV) vaccine effectiveness against RSV-associated hospitalisations and emergency department encounters among adults aged 60 years and older in the USA, October, 2023, to March, 2024: a test-negative design analysis
Payne AB , Watts JA , Mitchell PK , Dascomb K , Irving SA , Klein NP , Grannis SJ , Ong TC , Ball SW , DeSilva MB , Natarajan K , Sheffield T , Bride D , Arndorfer J , Naleway AL , Koppolu P , Fireman B , Zerbo O , Timbol J , Goddard K , Dixon BE , Fadel WF , Rogerson C , Allen KS , Rao S , Mayer D , Barron M , Reese SE , Rowley EAK , Najdowski M , Ciesla AA , Mak J , Reeves EL , Akinsete OO , McEvoy CE , Essien IJ , Tenforde MW , Fleming-Dutra KE , Link-Gelles R . Lancet 2024 404 (10462) 1547-1559 BACKGROUND: Respiratory syncytial virus vaccines first recommended for use during 2023 were efficacious against lower respiratory tract disease in clinical trials. Limited real-world data regarding respiratory syncytial virus vaccine effectiveness are available. To inform vaccine policy and address gaps in evidence from the clinical trials, we aimed to assess the effectiveness against respiratory syncytial virus-associated hospitalisations and emergency department encounters among adults aged at least 60 years. METHODS: We conducted a test-negative design analysis in an electronic health records-based network in eight states in the USA, including hospitalisations and emergency department encounters with respiratory syncytial virus-like illness among adults aged at least 60 years who underwent respiratory syncytial virus testing from Oct 1, 2023, to March 31, 2024. Respiratory syncytial virus vaccination status at the time of the encounter was derived from electronic health record documentation, state and city immunisation registries, and, for some sites, medical claims. Vaccine effectiveness was estimated by immunocompromise status, comparing the odds of vaccination among respiratory syncytial virus-positive case patients and respiratory syncytial virus-negative control patients, and adjusting for age, race and ethnicity, sex, calendar day, social vulnerability index, number of underlying non-respiratory medical conditions, presence of respiratory underlying medical conditions, and geographical region. FINDINGS: Among 28 271 hospitalisations for respiratory syncytial virus-like illness among adults aged at least 60 years without immunocompromising conditions, vaccine effectiveness was 80% (95% CI 71-85) against respiratory syncytial virus-associated hospitalisations, and vaccine effectiveness was 81% (52-92) against respiratory syncytial virus-associated critical illness (ICU admission or death, or both). Among 8435 hospitalisations for respiratory syncytial virus-like illness among adults with immunocompromising conditions, vaccine effectiveness was 73% (48-85) against associated hospitalisation. Among 36 521 emergency department encounters for respiratory syncytial virus-like illness among adults aged at least 60 years without an immunocompromising condition, vaccine effectiveness was 77% (70-83) against respiratory syncytial virus-associated emergency department encounters. Vaccine effectiveness estimates were similar by age group and product type. INTERPRETATION: Respiratory syncytial virus vaccination was effective in preventing respiratory syncytial virus-associated hospitalisations and emergency department encounters among adults aged at least 60 years in the USA during the 2023-24 respiratory syncytial virus season, which was the first season after respiratory syncytial virus vaccine was approved. FUNDING: The Centers for Disease Control and Prevention. |
The diabetes technology society error grid and trend accuracy matrix for glucose monitors
Klonoff DC , Freckmann G , Pleus S , Kovatchev BP , Kerr D , Tse CC , Li C , Agus MSD , Dungan K , Voglová Hagerf B , Krouwer JS , Lee WA , Misra S , Rhee SY , Sabharwal A , Seley JJ , Shah VN , Tran NK , Waki K , Worth C , Tian T , Aaron RE , Rutledge K , Ho CN , Ayers AT , Adler A , Ahn DT , Aktürk HK , Al-Sofiani ME , Bailey TS , Baker M , Bally L , Bannuru RR , Bauer EM , Bee YM , Blanchette JE , Cengiz E , Chase JG , YChen K , Cherñavvsky D , Clements M , Cote GL , Dhatariya KK , Drincic A , Ejskjaer N , Espinoza J , Fabris C , Fleming GA , Gabbay MAL , Galindo RJ , Gómez-Medina AM , Heinemann L , Hermanns N , Hoang T , Hussain S , Jacobs PG , Jendle J , Joshi SR , Koliwad SK , Lal RA , Leiter LA , Lind M , Mader JK , Maran A , Masharani U , Mathioudakis N , McShane M , Mehta C , Moon SJ , Nichols JH , O'Neal DN , Pasquel FJ , Peters AL , Pfützner A , Pop-Busui R , Ranjitkar P , Rhee CM , Sacks DB , Schmidt S , Schwaighofer SM , Sheng B , Simonson GD , Sode K , Spanakis EK , Spartano NL , Umpierrez GE , Vareth M , Vesper HW , Wang J , Wright E , Wu AHB , Yeshiwas S , Zilbermint M , Kohn MA . J Diabetes Sci Technol 2024 19322968241275701 INTRODUCTION: An error grid compares measured versus reference glucose concentrations to assign clinical risk values to observed errors. Widely used error grids for blood glucose monitors (BGMs) have limited value because they do not also reflect clinical accuracy of continuous glucose monitors (CGMs). METHODS: Diabetes Technology Society (DTS) convened 89 international experts in glucose monitoring to (1) smooth the borders of the Surveillance Error Grid (SEG) zones and create a user-friendly tool-the DTS Error Grid; (2) define five risk zones of clinical point accuracy (A-E) to be identical for BGMs and CGMs; (3) determine a relationship between DTS Error Grid percent in Zone A and mean absolute relative difference (MARD) from analyzing 22 BGM and nine CGM accuracy studies; and (4) create trend risk categories (1-5) for CGM trend accuracy. RESULTS: The DTS Error Grid for point accuracy contains five risk zones (A-E) with straight-line borders that can be applied to both BGM and CGM accuracy data. In a data set combining point accuracy data from 18 BGMs, 2.6% of total data pairs equally moved from Zones A to B and vice versa (SEG compared with DTS Error Grid). For every 1% increase in percent data in Zone A, the MARD decreased by approximately 0.33%. We also created a DTS Trend Accuracy Matrix with five trend risk categories (1-5) for CGM-reported trend indicators compared with reference trends calculated from reference glucose. CONCLUSION: The DTS Error Grid combines contemporary clinician input regarding clinical point accuracy for BGMs and CGMs. The DTS Trend Accuracy Matrix assesses accuracy of CGM trend indicators. |
Use of COVID-19 vaccines for persons aged ≥6 months: Recommendations of the advisory committee on immunization practices - United States, 2024-2025
Panagiotakopoulos L , Moulia DL , Godfrey M , Link-Gelles R , Roper L , Havers FP , Taylor CA , Stokley S , Talbot HK , Schechter R , Brooks O , Daley MF , Fleming-Dutra KE , Wallace M . MMWR Morb Mortal Wkly Rep 2024 73 (37) 819-824 COVID-19 vaccination provides additional protection against severe COVID-19-associated illness and death. Since September 2023, 2023-2024 Formula monovalent XBB.1-strain COVID-19 vaccines have been recommended for use in the United States for all persons aged ≥6 months. However, SARS-CoV-2 continues to evolve, and since winter 2023-2024, Omicron JN.1 lineage strains of SARS-CoV-2, including the JN.1 strain and the KP.2 strain, have been widely circulating in the United States. Further, COVID-19 vaccine effectiveness is known to wane. On June 27, 2024, the Advisory Committee on Immunization Practices (ACIP) recommended 2024-2025 COVID-19 vaccination with a Food and Drug Administration (FDA)-approved or authorized vaccine for all persons aged ≥6 months. On August 22, 2024, FDA approved the 2024-2025 COVID-19 vaccines by Moderna and Pfizer-BioNTech (based on the KP.2 strain) for use in persons aged ≥12 years and authorized these vaccines for use in children aged 6 months-11 years under Emergency Use Authorization (EUA). On August 30, 2024, FDA authorized 2024-2025 COVID-19 vaccine by Novavax (based on the JN.1 strain) for use in persons aged ≥12 years under EUA. ACIP will continue to evaluate new evidence as it becomes available and will update recommendations as needed. |
Effectiveness of the original monovalent and bivalent COVID-19 vaccines against COVID-19-associated emergency department and urgent care encounters in pregnant persons who were not immunocompromised: VISION Network, June 2022-August 2023
Avrich Ciesla A , Lazariu V , Dascomb K , Irving SA , Dixon BE , Gaglani M , Naleway AL , Grannis SJ , Ball S , Kharbanda AB , Vazquez-Benitez G , Klein NP , Natarajan K , Ong TC , Embi PJ , Fleming-Dutra KE , Link-Gelles R , Zerbo O . Open Forum Infect Dis 2024 11 (9) ofae481 Pregnant people face increased risk of severe COVID-19. Current guidelines recommend updated COVID-19 vaccination (2023-2024) for those aged ≥6 months, irrespective of pregnancy status. To refine recommendations for pregnant people, further data are needed. Using a test-negative design, we evaluated COVID-19 vaccine effectiveness against medically attended COVID-19 with COVID-19-like illness among pregnant people aged 18 to 45 years during June 2022 to August 2023. When doses were received during pregnancy, vaccine effectiveness was 52% (95% CI, 29%-67%); when received <6 months prior to pregnancy, 28% (95% CI, 11%-42%); and when received ≥6 months prior to pregnancy, 6% (95% CI, -11% to 21%). Pregnant people should stay up-to-date with recommended COVID-19 vaccination. |
Incorrect administration of adult RSV vaccines to young children
Moro PL , Scheffey A , Gallego R , Jones JM , Hall E , Zhang B , Fleming-Dutra KE , Broder KR . Pediatrics 2024 153 (6) |
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 L , Godfrey M , Moulia DL , Link-Gelles R , Taylor CA , Chatham-Stephens K , Brooks O , Daley MF , Fleming-Dutra KE , Wallace M . MMWR Morb Mortal Wkly Rep 2024 73 (16) 377-381 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. |
Interim effectiveness of updated 2023-2024 (monovalent XBB.1.5) COVID-19 vaccines against COVID-19-associated hospitalization among adults aged ≥18 years with immunocompromising conditions - VISION Network, September 2023-February 2024
Link-Gelles R , Rowley EAK , DeSilva MB , Dascomb K , Irving SA , Klein NP , Grannis SJ , Ong TC , Weber ZA , Fleming-Dutra KE , McEvoy CE , Akinsete O , Bride D , Sheffield T , Naleway AL , Zerbo O , Fireman B , Hansen J , Goddard K , Dixon BE , Rogerson C , Fadel WF , Duszynski T , Rao S , Barron MA , Reese SE , Ball SW , Dunne MM , Natarajan K , Okwuazi E , Shah AB , Wiegand R , Tenforde MW , Payne AB . MMWR Morb Mortal Wkly Rep 2024 73 (12) 271-276 ![]() ![]() In September 2023, CDC's Advisory Committee on Immunization Practices recommended updated 2023-2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. As with past COVID-19 vaccines, additional doses may be considered for persons with immunocompromising conditions, who are at higher risk for severe COVID-19 and might have decreased response to vaccination. In this analysis, vaccine effectiveness (VE) of an updated COVID-19 vaccine dose against COVID-19-associated hospitalization was evaluated during September 2023-February 2024 using data from the VISION VE network. Among adults aged ≥18 years with immunocompromising conditions, VE against COVID-19-associated hospitalization was 38% in the 7-59 days after receipt of an updated vaccine dose and 34% in the 60-119 days after receipt of an updated dose. Few persons (18%) in this high-risk study population had received updated COVID-19 vaccine. All persons aged ≥6 months should receive updated 2023-2024 COVID-19 vaccination; persons with immunocompromising conditions may get additional updated COVID-19 vaccine doses ≥2 months after the last recommended COVID-19 vaccine. |
Estimating the subnational prevalence of antimicrobial resistant Salmonella enterica serovars Typhi and Paratyphi A infections in 75 endemic countries, 1990-2019: a modelling study
GRAM Typhoid Collaborators , Munywoki P K , Verani J R . Lancet Glob Health 2024 12 (3) e406-e418 ![]() BACKGROUND: Enteric fever, a systemic infection caused by Salmonella enterica serovars Typhi and Paratyphi A, remains a major cause of morbidity and mortality in low-income and middle-income countries. Enteric fever is preventable through the provision of clean water and adequate sanitation and can be successfully treated with antibiotics. However, high levels of antimicrobial resistance (AMR) compromise the effectiveness of treatment. We provide estimates of the prevalence of AMR S Typhi and S Paratyphi A in 75 endemic countries, including 30 locations without data. METHODS: We used a Bayesian spatiotemporal modelling framework to estimate the percentage of multidrug resistance (MDR), fluoroquinolone non-susceptibility (FQNS), and third-generation cephalosporin resistance in S Typhi and S Paratyphi A infections for 1403 administrative level one districts in 75 endemic countries from 1990 to 2019. We incorporated data from a comprehensive systematic review, public health surveillance networks, and large multicountry studies on enteric fever. Estimates of the prevalence of AMR and the number of AMR infections (based on enteric fever incidence estimates by the Global Burden of Diseases study) were produced at the country, super-region, and total endemic area level for each year of the study. FINDINGS: We collated data from 601 sources, comprising 184 225 isolates of S Typhi and S Paratyphi A, covering 45 countries over 30 years. We identified a decline of MDR S Typhi in south Asia and southeast Asia, whereas in sub-Saharan Africa, the overall prevalence increased from 6·0% (95% uncertainty interval 4·3-8·0) in 1990 to 72·7% (67·7-77·3) in 2019. Starting from low levels in 1990, the prevalence of FQNS S Typhi increased rapidly, reaching 95·2% (91·4-97·7) in south Asia in 2019. This corresponded to 2·5 million (1·5-3·8) MDR S Typhi infections and 7·4 million (4·7-11·3) FQNS S Typhi infections in endemic countries in 2019. The prevalence of third-generation cephalosporin-resistant S Typhi remained low across the whole endemic area over the study period, except for Pakistan where prevalence of third-generation cephalosporin resistance in S Typhi reached 61·0% (58·0-63·8) in 2019. For S Paratyphi A, we estimated low prevalence of MDR and third-generation cephalosporin resistance in all endemic countries, but a drastic increase of FQNS, which reached 95·0% (93·7-96·1; 3·5 million [2·2-5·6] infections) in 2019. INTERPRETATION: This study provides a comprehensive and detailed analysis of the prevalence of MDR, FQNS, and third-generation cephalosporin resistance in S Typhi and S Paratyphi A infections in endemic countries, spanning the last 30 years. Our analysis highlights the increasing levels of AMR in this preventable infection and serves as a resource to guide urgently needed public health interventions, such as improvements in water, sanitation, and hygiene and typhoid fever vaccination campaigns. FUNDING: Fleming Fund, UK Department of Health and Social Care; Wellcome Trust; and Bill and Melinda Gates Foundation. |
Global VAX: A U.S. contribution to global COVID-19 vaccination efforts, 2021-2023
Dahl BA , Tritter B , Butryn D , Dahlke M , Browning S , Gelting R , Fleming M , Ortiz N , Labrador J , Novak R , Fitter D , Bell E , McGuire M , Rosenbaum R , Pulwer R , Wun J , McCaffrey A , Chowdhury M , Parks N , Cunningham M , Mounts A , Curry D , Richardson D , Grant G . Vaccine 2024 In December 2021 the U.S. Government announced a new, whole-of-government $1.8 billion effort, the Initiative for Global Vaccine Access (Global VAX) in response to the global COVID-19 pandemic. Using the foundation of decades of U.S. government investments in global health and working in close partnership with local governments and key global and multilateral organizations, Global VAX enabled the rapid acceleration of the global COVID-19 vaccine rollout in selected countries, contributing to increased COVID-19 vaccine coverage in some of the world's most vulnerable communities. Through Global VAX, the U.S. Government has supported 125 countries to scale up COVID-19 vaccine delivery and administration while strengthening primary health care systems to respond to future health crises. The progress made by Global VAX has paved the way for a stronger global recovery and improved global health security. |
Interim effectiveness of updated 2023-2024 (monovalent xbb.1.5) COVID-19 vaccines against COVID-19-associated emergency department and urgent care encounters and hospitalization among immunocompetent adults aged ≥18 years - VISION and IVY Networks, September 2023-January 2024
DeCuir J , Payne AB , Self WH , Rowley EAK , Dascomb K , DeSilva MB , Irving SA , Grannis SJ , Ong TC , Klein NP , Weber ZA , Reese SE , Ball SW , Barron MA , Naleway AL , Dixon BE , Essien I , Bride D , Natarajan K , Fireman B , Shah AB , Okwuazi E , Wiegand R , Zhu Y , Lauring AS , Martin ET , Gaglani M , Peltan ID , Brown SM , Ginde AA , Mohr NM , Gibbs KW , Hager DN , Prekker M , Mohamed A , Srinivasan V , Steingrub JS , Khan A , Busse LW , Duggal A , Wilson JG , Chang SY , Mallow C , Kwon JH , Exline MC , Columbus C , Vaughn IA , Safdar B , Mosier JM , Harris ES , Casey JD , Chappell JD , Grijalva CG , Swan SA , Johnson C , Lewis NM , Ellington S , Adams K , Tenforde MW , Paden CR , Dawood FS , Fleming-Dutra KE , Surie D , Link-Gelles R . MMWR Morb Mortal Wkly Rep 2024 73 (8) 180-188 In September 2023, CDC's Advisory Committee on Immunization Practices recommended updated 2023-2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. However, few estimates of updated vaccine effectiveness (VE) against medically attended illness are available. This analysis evaluated VE of an updated COVID-19 vaccine dose against COVID-19-associated emergency department (ED) or urgent care (UC) encounters and hospitalization among immunocompetent adults aged ≥18 years during September 2023-January 2024 using a test-negative, case-control design with data from two CDC VE networks. VE against COVID-19-associated ED/UC encounters was 51% (95% CI = 47%-54%) during the first 7-59 days after an updated dose and 39% (95% CI = 33%-45%) during the 60-119 days after an updated dose. VE estimates against COVID-19-associated hospitalization from two CDC VE networks were 52% (95% CI = 47%-57%) and 43% (95% CI = 27%-56%), with a median interval from updated dose of 42 and 47 days, respectively. Updated COVID-19 vaccine provided increased protection against COVID-19-associated ED/UC encounters and hospitalization among immunocompetent adults. These results support CDC recommendations for updated 2023-2024 COVID-19 vaccination. All persons aged ≥6 months should receive updated 2023-2024 COVID-19 vaccine. |
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 R , Ciesla AA , Mak J , Miller JD , Silk BJ , Lambrou AS , Paden CR , Shirk P , Britton A , Smith ZR , Fleming-Dutra KE . MMWR Morb Mortal Wkly Rep 2024 73 (4) 77-83 ![]() ![]() 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. |
A standardised method for interpreting the association between mutations and phenotypic drug resistance in Mycobacterium tuberculosis.
Miotto P , Tessema B , Tagliani E , Chindelevitch L , Starks AM , Emerson C , Hanna D , Kim PS , Liwski R , Zignol M , Gilpin C , Niemann S , Denkinger CM , Fleming J , Warren RM , Crook D , Posey J , Gagneux S , Hoffner S , Rodrigues C , Comas I , Engelthaler DM , Murray M , Alland D , Rigouts L , Lange C , Dheda K , Hasan R , Ranganathan UDK , McNerney R , Ezewudo M , Cirillo DM , Schito M , Köser CU , Rodwell TC . Eur Respir J 2017 50 (6) ![]() A clear understanding of the genetic basis of antibiotic resistance in Mycobacterium tuberculosis is required to accelerate the development of rapid drug susceptibility testing methods based on genetic sequence.Raw genotype-phenotype correlation data were extracted as part of a comprehensive systematic review to develop a standardised analytical approach for interpreting resistance associated mutations for rifampicin, isoniazid, ofloxacin/levofloxacin, moxifloxacin, amikacin, kanamycin, capreomycin, streptomycin, ethionamide/prothionamide and pyrazinamide. Mutation frequencies in resistant and susceptible isolates were calculated, together with novel statistical measures to classify mutations as high, moderate, minimal or indeterminate confidence for predicting resistance.We identified 286 confidence-graded mutations associated with resistance. Compared to phenotypic methods, sensitivity (95% CI) for rifampicin was 90.3% (89.6-90.9%), while for isoniazid it was 78.2% (77.4-79.0%) and their specificities were 96.3% (95.7-96.8%) and 94.4% (93.1-95.5%), respectively. For second-line drugs, sensitivity varied from 67.4% (64.1-70.6%) for capreomycin to 88.2% (85.1-90.9%) for moxifloxacin, with specificity ranging from 90.0% (87.1-92.5%) for moxifloxacin to 99.5% (99.0-99.8%) for amikacin.This study provides a standardised and comprehensive approach for the interpretation of mutations as predictors of M. tuberculosis drug-resistant phenotypes. These data have implications for the clinical interpretation of molecular diagnostics and next-generation sequencing as well as efficient individualised therapy for patients with drug-resistant tuberculosis. |
Perceptions toward Ebola vaccination and correlates of vaccine uptake among high-risk community members in North Kivu, Democratic Republic of the Congo
Perera SM , Garbern SC , Mbong EN , Fleming MK , Muhayangabo RF , Ombeni AB , Kulkarni S , Tchoualeu DD , Kallay R , Song E , Powell J , Gainey M , Glenn B , Mutumwa RM , Mustafa SHB , Earle-Richardson G , Fukunaga R , Abad N , Soke GN , Prybylski D , Fitter DL , Levine AC , Doshi RH . PLOS Glob Public Health 2024 4 (1) e0002566 The tenth Ebola Virus Disease (EVD) outbreak (2018-2020, North Kivu, Ituri, South Kivu) in the Democratic Republic of the Congo (DRC) was the second-largest EVD outbreak in history. During this outbreak, Ebola vaccination was an integral part of the EVD response. We evaluated community perceptions toward Ebola vaccination and identified correlates of Ebola vaccine uptake among high-risk community members in North Kivu, DRC. In March 2021, a cross-sectional survey among adults was implemented in three health zones. We employed a sampling approach mimicking ring vaccination, targeting EVD survivors, their household members, and their neighbors. Outbreak experiences and perceptions toward the Ebola vaccine were assessed, and modified Poisson regression was used to identify correlates of Ebola vaccine uptake among those offered vaccination. Among the 631 individuals surveyed, most (90.2%) reported a high perceived risk of EVD and 71.6% believed that the vaccine could reduce EVD severity; however, 63.7% believed the vaccine had serious side effects. Among the 474 individuals who had been offered vaccination, 397 (83.8%) received the vaccine, 180 (45.3%) of those vaccinated received the vaccine after two or more offers. Correlates positively associated with vaccine uptake included having heard positive information about the vaccine (RR 1.30, 95% CI 1.06-1.60), the belief that the vaccine could prevent EVD (RR 1.23, 95% CI 1.09-1.39), and reporting that religion influenced all decisions (RR 1.13, 95% CI 1.02-1.25). Ebola vaccine uptake was high in this population, although mixed attitudes and vaccine delays were common. Communicating positive vaccine information, emphasizing the efficacy of the Ebola vaccine, and engaging religious leaders to promote vaccination may aid in increasing Ebola vaccine uptake during future outbreaks. |
Estimates of congenital cytomegalovirus-attributable infant mortality in high-income countries: A review
Grosse SD , Fleming P , Pesch MH , Rawlinson WD . Rev Med Virol 2024 34 (1) e2502 As many as 5%–10% of infants with symptomatic congenital cytomegalovirus (cCMV) disease, or 0.4%–0.8% of all liveborn infants with cCMV infection, die in early infancy in high-income countries. However, estimates are uncertain due to several potential biases that can result from data limitations and study designs. First, infants with cCMV infections who die prior to diagnosis, which usually occurs at 1–4 weeks after birth, may be excluded from both the count of deaths and the denominator of cCMV births, resulting in left truncation and immortal time biases. These ‘biases’ are features of the data and do not reflect bias on the part of researchers, but understanding the potential existence of threats to validity can help with interpretation of findings. Left truncation of infant deaths occurring prior to diagnosis of cCMV can result in understatement of the burden of infant deaths due to cCMV. Conversely, overestimation of infant deaths associated with symptomatic cCMV may occur in clinical case series owing to greater representation of relatively severely affected infants owing to ascertainment and referral biases. In this review, we summarise the characteristics of 26 studies that reported estimates of cCMV-associated infant deaths, including potential biases or limitations to which those estimates may have been subject. We discuss study designs whose implementation might generate improved estimates of infant deaths attributable to cCMV. More complete estimates of the overall public health impact of cCMV could inform current and future screening, prevention, and vaccine research. © 2024 John Wiley & Sons Ltd. |
Development of COVID-19 vaccine policy - United States, 2020-2023
Oliver SE , Wallace M , Twentyman E , Moulia DL , Godfrey M , Link-Gelles R , Meyer S , Fleming-Dutra KE , Hall E , Wolicki J , MacNeil J , Bell BP , Lee GM , Daley MF , Cohn A , Wharton M . Vaccine 2023 ![]() ![]() COVID-19 vaccines represent a great scientific and public health achievement in the face of overwhelming pressures from a global pandemic, preventing millions of hospitalizations and deaths due to COVID-19 vaccines in the United States. Over 675 million doses of COVID-19 vaccines have been administered in the United States, and over 80% of the U.S. population has had at least 1 dose of a COVID-19 vaccine. Over the course of the COVID-19 pandemic in the United States, over one million people died from COVID-19, and over six million were hospitalized. It has been estimated that COVID-19 vaccines prevented more than 18 million additional hospitalizations and more than 3 million additional deaths due to COVID-19 in the United States. From the beginning of the COVID-19 pandemic in 2020 through June 2023, ACIP had 35 COVID-19 focused meetings and 24 votes for COVID-19 vaccine recommendations. ACIP had the critical task of rapidly and thoroughly reviewing emerging and evolving data on COVID-19 epidemiology and vaccines, as well as making comprehensive population-based recommendations for vaccine policy and considerations for implementation through a transparent and evidence-based framework. Safe and effective COVID-19 vaccines, recommended through transparent policy discussions with ACIP, remain the best tool we have to prevent serious illness, hospitalization and death from COVID-19. |
Tropical data: Approach and methodology as applied to trachoma prevalence surveys
Harding-Esch EM , Burgert-Brucker CR , Jimenez C , Bakhtiari A , Willis R , Bejiga MD , Mpyet C , Ngondi J , Boyd S , Abdala M , Abdou A , Adamu Y , Alemayehu A , Alemayehu W , Al-Khatib T , Apadinuwe SC , Awaca N , Awoussi MS , Baayendag G , Badiane MD , Bailey RL , Batcho W , Bay Z , Bella A , Beido N , Bol YY , Bougouma C , Brady CJ , Bucumi V , Butcher R , Cakacaka R , Cama A , Camara M , Cassama E , Chaora SG , Chebbi AC , Chisambi AB , Chu B , Conteh A , Coulibaly SM , Courtright P , Dalmar A , Dat TM , Davids T , Djaker MEA , de Fátima Costa Lopes M , Dézoumbé D , Dodson S , Downs P , Eckman S , Elshafie BE , Elmezoghi M , Elvis AA , Emerson P , Epée EE , Faktaufon D , Fall M , Fassinou A , Fleming F , Flueckiger R , Gamael KK , Garae M , Garap J , Gass K , Gebru G , Gichangi MM , Giorgi E , Goépogui A , Gómez DVF , Gómez Forero DP , Gower EW , Harte A , Henry R , Honorio-Morales HA , Ilako DR , Issifou AAB , Jones E , Kabona G , Kabore M , Kadri B , Kalua K , Kanyi SK , Kebede S , Kebede F , Keenan JD , Kello AB , Khan AA , Khelifi H , Kilangalanga J , Kim SH , Ko R , Lewallen S , Lietman T , Logora MSY , Lopez YA , MacArthur C , Macleod C , Makangila F , Mariko B , Martin DL , Masika M , Massae P , Massangaie M , Matendechero HS , Mathewos T , McCullagh S , Meite A , Mendes EP , Abdi HM , Miller H , Minnih A , Mishra SK , Molefi T , Mosher A , M'Po N , Mugume F , Mukwiza R , Mwale C , Mwatha S , Mwingira U , Nash SD , Nassa C , Negussu N , Nieba C , Noah Noah JC , Nwosu CO , Olobio N , Opon R , Pavluck A , Phiri I , Rainima-Qaniuci M , Renneker KK , Saboyá-Díaz MI , Sakho F , Sanha S , Sarah V , Sarr B , Szwarcwald CL , Shah Salam A , Sharma S , Seife F , Serrano Chavez GM , Sissoko M , Sitoe HM , Sokana O , Tadesse F , Taleo F , Talero SL , Tarfani Y , Tefera A , Tekeraoi R , Tesfazion A , Traina A , Traoré L , Trujillo-Trujillo J , Tukahebwa EM , Vashist P , Wanyama EB , Warusavithana SDP , Watitu TK , West S , Win Y , Woods G , Yajima A , Yaya G , Zecarias A , Zewengiel S , Zoumanigui A , Hooper PJ , Millar T , Rotondo L , Solomon AW . Ophthalmic Epidemiol 2023 30 (6) 544-560 PURPOSE: Population-based prevalence surveys are essential for decision-making on interventions to achieve trachoma elimination as a public health problem. This paper outlines the methodologies of Tropical Data, which supports work to undertake those surveys. METHODS: Tropical Data is a consortium of partners that supports health ministries worldwide to conduct globally standardised prevalence surveys that conform to World Health Organization recommendations. Founding principles are health ministry ownership, partnership and collaboration, and quality assurance and quality control at every step of the survey process. Support covers survey planning, survey design, training, electronic data collection and fieldwork, and data management, analysis and dissemination. Methods are adapted to meet local context and needs. Customisations, operational research and integration of other diseases into routine trachoma surveys have also been supported. RESULTS: Between 29(th) February 2016 and 24(th) April 2023, 3373 trachoma surveys across 50 countries have been supported, resulting in 10,818,502 people being examined for trachoma. CONCLUSION: This health ministry-led, standardised approach, with support from the start to the end of the survey process, has helped all trachoma elimination stakeholders to know where interventions are needed, where interventions can be stopped, and when elimination as a public health problem has been achieved. Flexibility to meet specific country contexts, adaptation to changes in global guidance and adjustments in response to user feedback have facilitated innovation in evidence-based methodologies, and supported health ministries to strive for global disease control targets. |
Characteristics and clinical outcomes of vaccine-eligible US children under-5 years hospitalized for acute COVID-19 in a national network
Zambrano LD , Newhams MM , Simeone RM , Fleming-Dutra KE , Halasa N , Wu M , Orzel-Lockwood AO , Kamidani S , Pannaraj PS , Chiotos K , Cameron MA , Maddux AB , Schuster JE , Crandall H , Kong M , Nofziger RA , Staat MA , Bhumbra SS , Irby K , Boom JA , Sahni LC , Hume JR , Gertz SJ , Maamari M , Bowens C , Levy ER , Bradford TT , Walker TC , Schwartz SP , Mack EH , Guzman-Cottrill JA , Hobbs CV , Zinter MS , Cvijanovich NZ , Bline KE , Hymes SR , Campbell AP , Randolph AG . Pediatr Infect Dis J 2023 BACKGROUND AND OBJECTIVES: In June 2022, the mRNA COVID-19 vaccination was recommended for young children. We examined clinical characteristics and factors associated with vaccination status among vaccine-eligible young children hospitalized for acute COVID-19. METHODS: We enrolled inpatients aged 8 months to <5 years with acute community-acquired COVID-19 across 28 US pediatric hospitals from September 20, 2022 to May 31, 2023. We assessed demographic and clinical factors, including the highest level of respiratory support, and vaccination status defined as unvaccinated, incomplete, or complete primary series [at least 2 (Moderna) or 3 (Pfizer-BioNTech) mRNA vaccine doses ≥14 days before hospitalization]. RESULTS: Among 597 children, 174 (29.1%) patients were admitted to the intensive care unit and 75 (12.6%) had a life-threatening illness, including 51 (8.5%) requiring invasive mechanical ventilation. Children with underlying respiratory and neurologic/neuromuscular conditions more frequently received higher respiratory support. Only 4.5% of children hospitalized for COVID-19 (n = 27) had completed their primary COVID-19 vaccination series and 7.0% (n = 42) of children initiated but did not complete their primary series. Among 528 unvaccinated children, nearly half (n = 251) were previously healthy, 3 of them required extracorporeal membrane oxygenation for acute COVID-19 and 1 died. CONCLUSIONS: Most young children hospitalized for acute COVID-19, including most children admitted to the intensive care unit and with life-threatening illness, had not initiated COVID-19 vaccination despite being eligible. Nearly half of these children had no underlying conditions. Of the small percentage of children who initiated a COVID-19 primary series, most had not completed it before hospitalization. |
Building the U.S. COVID-19 vaccine effectiveness program: Past successes and future directions
Link-Gelles R , Britton A , Fleming-Dutra KE . Vaccine 2023 ![]() 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. |
Effectiveness of a bivalent mRNA vaccine dose against symptomatic SARS-CoV-2 infection among U.S. Healthcare personnel, September 2022-May 2023
Plumb ID , Briggs Hagen M , Wiegand R , Dumyati G , Myers C , Harland KK , Krishnadasan A , James Gist J , Abedi G , Fleming-Dutra KE , Chea N , Lee JE , Kellogg M , Edmundson A , Britton A , Wilson LE , Lovett SA , Ocampo V , Markus TM , Smithline HA , Hou PC , Lee LC , Mower W , Rwamwejo F , Steele MT , Lim SC , Schrading WA , Chinnock B , Beiser DG , Faine B , Haran JP , Nandi U , Chipman AK , LoVecchio F , Eucker S , Femling J , Fuller M , Rothman RE , Curlin ME , Talan DA , Mohr NM . Vaccine 2023 ![]() ![]() BACKGROUND: Bivalent mRNA vaccines were recommended since September 2022. However, coverage with a recent vaccine dose has been limited, and there are few robust estimates of bivalent VE against symptomatic SARS-CoV-2 infection (COVID-19). We estimated VE of a bivalent mRNA vaccine dose against COVID-19 among eligible U.S. healthcare personnel who had previously received monovalent mRNA vaccine doses. METHODS: We conducted a case-control study in 22 U.S. states, and enrolled healthcare personnel with COVID-19 (case-participants) or without COVID-19 (control-participants) during September 2022-May 2023. Participants were considered eligible for a bivalent mRNA dose if they had received 2-4 monovalent (ancestral-strain) mRNA vaccine doses, and were ≥67 days after the most recent vaccine dose. We estimated VE of a bivalent mRNA dose using conditional logistic regression, accounting for matching by region and four-week calendar period. We adjusted estimates for age group, sex, race and ethnicity, educational level, underlying health conditions, community COVID-19 exposure, prior SARS-CoV-2 infection, and days since the last monovalent mRNA dose. RESULTS: Among 3,647 healthcare personnel, 1,528 were included as case-participants and 2,119 as control-participants. Participants received their last monovalent mRNA dose a median of 404 days previously; 1,234 (33.8%) also received a bivalent mRNA dose a median of 93 days previously. Overall, VE of a bivalent dose was 34.1% (95% CI, 22.6%-43.9%) against COVID-19 and was similar by product, days since last monovalent dose, number of prior doses, age group, and presence of underlying health conditions. However, VE declined from 54.8% (95% CI, 40.7%-65.6%) after 7-59 days to 21.6% (95% CI 5.6%-34.9%) after ≥60 days. CONCLUSIONS: Bivalent mRNA COVID-19 vaccines initially conferred approximately 55% protection against COVID-19 among U.S. healthcare personnel. However, protection waned after two months. These findings indicate moderate initial protection against symptomatic SARS-CoV-2 infection by remaining up-to-date with COVID-19 vaccines. |
Pre-Delta, Delta, and Omicron periods of the coronavirus disease 2019 (COVID-19) pandemic and health outcomes during delivery hospitalization
Carlson J , Simeone RM , Ellington S , Galang R , DeSisto CL , Fleming-Dutra K , Riley L , Meaney-Delman D , Tong VT . Obstet Gynecol 2023 143 (1) 131-138 ![]() OBJECTIVE: To examine the relationship between coronavirus disease 2019 (COVID-19) diagnosis at delivery and adverse maternal health and pregnancy outcomes during pre-Delta, Delta, and Omicron variant predominance, with a focus on the time period of Omicron variant predominance. METHODS: We conducted a cross-sectional observational study with data from delivery hospitalizations in the Premier Healthcare Database from February 2020 to August 2023. The pre-Delta (February 2020-June 2021), Delta (July 2021-December 2021), and Omicron (January 2022-August 2023) periods of variant predominance were examined. Exposure to COVID-19 was identified by having a diagnostic code for COVID-19 during the delivery hospitalization. Adjusted prevalence ratios (aPRs) were calculated to compare the risks of adverse maternal and pregnancy outcomes for women with and without COVID-19 diagnoses at the time of delivery for each variant period. RESULTS: Among 2,990,973 women with delivery hospitalizations, 1.9% (n=56,618) had COVID-19 diagnoses noted at delivery admission discharge, including 26,053 during the Omicron period. Across all variant time periods, the prevalence of many adverse maternal and pregnancy outcomes during the delivery hospitalization was significantly higher for pregnant women with COVID-19 compared with pregnant women without COVID-19. In adjusted models, COVID-19 during the Omicron period was associated with significant increased risks for maternal sepsis (COVID-19: 0.4% vs no COVID-19: 0.1%; aPR 3.32, 95% CI, 2.70-4.08), acute respiratory distress syndrome (0.6% vs 0.1%; aPR 6.19, 95% CI, 5.26-7.29), shock (0.2% vs 0.1%; aPR 2.14, 95% CI, 1.62-2.84), renal failure (0.5% vs 0.2%; aPR 2.08, 95% CI, 1.73-2.49), intensive care unit admission (2.7% vs 1.7%; aPR 1.64, 95% CI, 1.52-1.77), mechanical ventilation (0.3% vs 0.1%; aPR 3.15, 95% CI, 2.52-3.93), in-hospital death (0.03% vs 0.01%; aPR 5.00, 95% CI, 2.30-10.90), stillbirth (0.7% vs 0.6%; aPR 1.17, 95% CI, 1.01-1.36), and preterm delivery (12.3% vs 9.6%; aPR 1.28, 95% CI, 1.24-1.33). CONCLUSION: Despite the possibility of some level of immunity due to previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, vaccination, or testing differences, risks of adverse outcomes associated with COVID-19 diagnosis at delivery remained elevated during the Omicron variant time period. |
Use of updated COVID-19 vaccines 2023-2024 formula for persons aged ≥6 months: Recommendations of the Advisory Committee on Immunization Practices - United States, September 2023
Regan JJ , Moulia DL , Link-Gelles R , Godfrey M , Mak J , Najdowski M , Rosenblum HG , Shah MM , Twentyman E , Meyer S , Peacock G , Thornburg N , Havers FP , Saydah S , Brooks O , Talbot HK , Lee GM , Bell BP , Mahon BE , Daley MF , Fleming-Dutra KE , Wallace M . MMWR Morb Mortal Wkly Rep 2023 72 (42) 1140-1146 COVID-19 vaccines protect against severe COVID-19-associated outcomes, including hospitalization and death. As SARS-CoV-2 has evolved, and waning vaccine effectiveness has been noted, vaccine formulations and policies have been updated to provide continued protection against severe illness and death from COVID-19. Since September 2022, bivalent mRNA COVID-19 vaccines have been recommended in the United States, but the variants these vaccines protect against are no longer circulating widely. On September 11, 2023, the Food and Drug Administration (FDA) approved the updated (2023-2024 Formula) COVID-19 mRNA vaccines by Moderna and Pfizer-BioNTech for persons aged ≥12 years and authorized these vaccines for persons aged 6 months-11 years under Emergency Use Authorization (EUA). On October 3, 2023, FDA authorized the updated COVID-19 vaccine by Novavax for use in persons aged ≥12 years under EUA. The updated COVID-19 vaccines include a monovalent XBB.1.5 component, which is meant to broaden vaccine-induced immunity and provide protection against currently circulating SARS-CoV-2 XBB-sublineage variants including against severe COVID-19-associated illness and death. On September 12, 2023, the Advisory Committee on Immunization Practices recommended vaccination with updated COVID-19 vaccines for all persons aged ≥6 months. These recommendations will be reviewed as new evidence becomes available or new vaccines are approved and might be updated. |
Effectiveness of maternal mRNA COVID-19 vaccination during pregnancy against COVID-19-associated hospitalizations in infants aged <6 months during SARS-cov-2 Omicron predominance - 20 states, March 9, 2022-May 31, 2023
Simeone RM , Zambrano LD , Halasa NB , Fleming-Dutra KE , Newhams MM , Wu MJ , Orzel-Lockwood AO , Kamidani S , Pannaraj PS , Irby K , Maddux AB , Hobbs CV , Cameron MA , Boom JA , Sahni LC , Kong M , Nofziger RA , Schuster JE , Crandall H , Hume JR , Staat MA , Mack EH , Bradford TT , Heidemann SM , Levy ER , Gertz SJ , Bhumbra SS , Walker TC , Bline KE , Michelson KN , Zinter MS , Flori HR , Campbell AP , Randolph AG . MMWR Morb Mortal Wkly Rep 2023 72 (39) 1057-1064 Infants aged <6 months are not eligible for COVID-19 vaccination. Vaccination during pregnancy has been associated with protection against infant COVID-19-related hospitalization. The Overcoming COVID-19 Network conducted a case-control study during March 9, 2022-May 31, 2023, to evaluate the effectiveness of maternal receipt of a COVID-19 vaccine dose (vaccine effectiveness [VE]) during pregnancy against COVID-19-related hospitalization in infants aged <6 months and a subset of infants aged <3 months. VE was calculated as (1 - adjusted odds ratio) x 100% among all infants aged <6 months and <3 months. Case-patients (infants hospitalized for COVID-19 outside of birth hospitalization and who had a positive SARS-CoV-2 test result) and control patients (infants hospitalized for COVID-19-like illness with a negative SARS-CoV-2 test result) were compared. Odds ratios were determined using multivariable logistic regression, comparing the odds of receipt of a maternal COVID-19 vaccine dose (completion of a 2-dose vaccination series or a third or higher dose) during pregnancy with maternal nonvaccination between case- and control patients. VE of maternal vaccination during pregnancy against COVID-19-related hospitalization was 35% (95% CI = 15%-51%) among infants aged <6 months and 54% (95% CI = 32%-68%) among infants aged <3 months. Intensive care unit admissions occurred in 23% of all case-patients, and invasive mechanical ventilation was more common among infants of unvaccinated (9%) compared with vaccinated mothers (1%) (p = 0.02). Maternal vaccination during pregnancy provides some protection against COVID-19-related hospitalizations among infants, particularly those aged <3 months. Expectant mothers should remain current with COVID-19 vaccination to protect themselves and their infants from hospitalization and severe outcomes associated with COVID-19. |
Use of the Pfizer respiratory syncytial virus vaccine during pregnancy for the prevention of respiratory syncytial virus-associated lower respiratory tract disease in infants: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023
Fleming-Dutra KE , Jones JM , Roper LE , Prill MM , Ortega-Sanchez IR , Moulia DL , Wallace M , Godfrey M , Broder KR , Tepper NK , Brooks O , Sánchez PJ , Kotton CN , Mahon BE , Long SS , McMorrow ML . MMWR Morb Mortal Wkly Rep 2023 72 (41) 1115-1122 Respiratory syncytial virus (RSV) is the leading cause of hospitalization among U.S. infants. Nirsevimab (Bevfortus, Sanofi and AstraZeneca) is recommended to prevent RSV-associated lower respiratory tract infection (LRTI) in infants. In August 2023, the Food and Drug Administration (FDA) approved RSVpreF vaccine (Abrysvo, Pfizer Inc.) for pregnant persons as a single dose during 32-36 completed gestational weeks (i.e., 32 weeks and zero days' through 36 weeks and 6 days' gestation) to prevent RSV-associated lower respiratory tract disease in infants aged <6 months. Since October 2021, CDC's Advisory Committee on Immunization Practices (ACIP) RSV Vaccines Pediatric/Maternal Work Group has reviewed RSV epidemiology and evidence regarding safety, efficacy, and potential economic impact of pediatric and maternal RSV prevention products, including RSVpreF vaccine. On September 22, 2023, ACIP and CDC recommended RSVpreF vaccine using seasonal administration (i.e., during September through end of January in most of the continental United States) for pregnant persons as a one-time dose at 32-36 weeks' gestation for prevention of RSV-associated LRTI in infants aged <6 months. Either maternal RSVpreF vaccination during pregnancy or nirsevimab administration to the infant is recommended to prevent RSV-associated LRTI among infants, but both are not needed for most infants. All infants should be protected against RSV-associated LRTI through use of one of these products. |
Effectiveness of a messenger RNA vaccine booster dose against coronavirus disease 2019 among US healthcare personnel, October 2021-July 2022
Plumb ID , Mohr NM , Hagen M , Wiegand R , Dumyati G , Harland KK , Krishnadasan A , Gist JJ , Abedi G , Fleming-Dutra KE , Chea N , Lee J , Barter D , Brackney M , Fridkin SK , Wilson LE , Lovett SA , Ocampo V , Phipps EC , Marcus TM , Smithline HA , Hou PC , Lee LC , Moran GJ , Krebs E , Steele MT , Lim SC , Schrading WA , Chinnock B , Beiser DG , Faine B , Haran JP , Nandi U , Chipman AK , LoVecchio F , Talan DA , Pilishvili T . Open Forum Infect Dis 2023 10 (10) ofad457 ![]() ![]() BACKGROUND: Protection against symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (coronavirus disease 2019 [COVID-19]) can limit transmission and the risk of post-COVID conditions, and is particularly important among healthcare personnel. However, lower vaccine effectiveness (VE) has been reported since predominance of the Omicron SARS-CoV-2 variant. METHODS: We evaluated the VE of a monovalent messenger RNA (mRNA) booster dose against COVID-19 from October 2021 to June 2022 among US healthcare personnel. After matching case-participants with COVID-19 to control-participants by 2-week period and site, we used conditional logistic regression to estimate the VE of a booster dose compared with completing only 2 mRNA doses >150 days previously, adjusted for multiple covariates. RESULTS: Among 3279 case-participants and 3998 control-participants who had completed 2 mRNA doses, we estimated that the VE of a booster dose against COVID-19 declined from 86% (95% confidence interval, 81%-90%) during Delta predominance to 65% (58%-70%) during Omicron predominance. During Omicron predominance, VE declined from 73% (95% confidence interval, 67%-79%) 14-60 days after the booster dose, to 32% (4%-52%) ≥120 days after a booster dose. We found that VE was similar by age group, presence of underlying health conditions, and pregnancy status on the test date, as well as among immunocompromised participants. CONCLUSIONS: A booster dose conferred substantial protection against COVID-19 among healthcare personnel. However, VE was lower during Omicron predominance, and waning effectiveness was observed 4 months after booster dose receipt during this period. Our findings support recommendations to stay up to date on recommended doses of COVID-19 vaccines for all those eligible. |
Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023
Jones JM , Fleming-Dutra KE , Prill MM , Roper LE , Brooks O , Sánchez PJ , Kotton CN , Mahon BE , Meyer S , Long SS , McMorrow ML . MMWR Morb Mortal Wkly Rep 2023 72 (34) 920-925 Respiratory syncytial virus (RSV) is the leading cause of hospitalization among U.S. infants. In July 2023, the Food and Drug Administration approved nirsevimab, a long-acting monoclonal antibody, for passive immunization to prevent RSV-associated lower respiratory tract infection among infants and young children. Since October 2021, the Advisory Committee on Immunization Practices (ACIP) Maternal and Pediatric RSV Work Group has reviewed evidence on the safety and efficacy of nirsevimab among infants and young children. On August 3, 2023, ACIP recommended nirsevimab for all infants aged <8 months who are born during or entering their first RSV season and for infants and children aged 8-19 months who are at increased risk for severe RSV disease and are entering their second RSV season. On the basis of pre-COVID-19 pandemic patterns, nirsevimab could be administered in most of the continental United States from October through the end of March. Nirsevimab can prevent severe RSV disease among infants and young children at increased risk for severe RSV disease. |
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