Last data update: Nov 04, 2024. (Total: 48056 publications since 2009)
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Interim effectiveness estimates of 2024 southern hemisphere influenza vaccines in preventing influenza-associated hospitalization - REVELAC-i Network, five South American countries, March-July 2024
Zeno EE , Nogareda F , Regan A , Couto P , Rondy M , Jara J , Voto C , Rojas Mena MP , Katz N , Del Valle Juarez M , Benedetti E , de Paula Júnior FJ , Ferreira da Almeida WA , Hott CE , Ferrari PR , Mallegas NV , Vigueras MA , Domínguez C , von Horoch M , Vazquez C , Silvera E , Chiparelli H , Goni N , Castro L , Marcenac P , Kondor RJ , Leite J , Velandia M , Azziz-Baumgartner E , Fowlkes AL , Salas D . MMWR Morb Mortal Wkly Rep 2024 73 (39) 861-868 To reduce influenza-associated morbidity and mortality, countries in South America recommend annual influenza vaccination for persons at high risk for severe influenza illness, including young children, persons with preexisting health conditions, and older adults. Interim estimates of influenza vaccine effectiveness (VE) from Southern Hemisphere countries can provide early information about the protective effects of vaccination and help guide Northern Hemisphere countries in advance of their season. Using data from a multicountry network, investigators estimated interim VE against influenza-associated severe acute respiratory illness (SARI) hospitalization using a test-negative case-control design. During March 13-July 19, 2024, Argentina, Brazil, Chile, Paraguay, and Uruguay identified 11,751 influenza-associated SARI cases; on average, 21.3% of patients were vaccinated against influenza, and the adjusted VE against hospitalization was 34.5%. The adjusted VE against the predominating subtype A(H3N2) was 36.5% and against A(H1N1)pdm09 was 37.1%. These interim VE estimates suggest that although the proportion of hospitalized patients who were vaccinated was modest, vaccination with the Southern Hemisphere influenza vaccine significantly lowered the risk for hospitalization. Northern Hemisphere countries should, therefore, anticipate the need for robust influenza vaccination campaigns and early antiviral treatment to achieve optimal protection against influenza-associated complications. |
Estimated health and economic outcomes of racial and ethnic tuberculosis disparities in US-born persons
Swartwood NA , Li Y , Regan M , Marks SM , Barham T , Beeler Asay GR , Cohen T , Hill AN , Horsburgh CR Jr , Khan AD , McCree DH , Myles RL , Salomon JA , Self JL , Menzies NA . JAMA Netw Open 2024 7 (9) e2431988 IMPORTANCE: Despite significant progress made toward tuberculosis (TB) elimination, racial and ethnic disparities persist in TB incidence and case-fatality rates in the US. OBJECTIVE: To estimate the health outcomes and economic cost of TB disparities among US-born persons from 2023 to 2035. DESIGN, SETTING, AND PARTICIPANTS: Generalized additive regression models projecting trends in TB incidence and case-fatality rates from 2023 to 2035 were fit based on national TB surveillance data for 2010 to 2019 in the 50 US states and the District of Columbia among US-born persons. This baseline scenario was compared with alternative scenarios in which racial and ethnic disparities in age- and sex-adjusted incidence and case-fatality rates were eliminated by setting rates for each race and ethnicity to goal values. Additional scenarios were created examining the potential outcomes of delayed reduction of racial and ethnic disparities. The potential benefits of eliminating disparities from differences between baseline and alternative scenario outcomes were quantified. Data were analyzed from January 2010 to December 2019. EXPOSURES: Non-Hispanic American Indian or Alaska Native, non-Hispanic Asian, non-Hispanic Black, Hispanic, non-Hispanic Native Hawaiian or Other Pacific Islander, or non-Hispanic White race and ethnicity. MAIN OUTCOMES AND MEASURES: TB cases and deaths averted, quality-adjusted life years gained, and associated costs from a societal perspective. RESULTS: The study included 31 811 persons with reported TB from 2010 to 2019 (mean [SD] age, 47 [24] years; 20 504 [64%] male; 1179 [4%] American Indian or Alaska Native persons; 1332 [4%] Asian persons; 12 152 [38%] Black persons; 6595 [21%] Hispanic persons; 299 [1%] Native Hawaiian or Other Pacific Islander persons; and 10 254 [32%] White persons). There were 3722 persons with a reported TB death. Persistent racial and ethnic disparities were associated with an estimated 11 901 of 26 203 TB cases among US-born persons (45%; 95% uncertainty interval [UI], 44%-47%), 1421 of 3264 TB deaths among US-born persons (44%; 95% UI, 39%-48%), and an economic cost of $914 (95% UI, $675-$1147) million from 2023 to 2035. Delayed goal attainment reduced the estimated avertable TB outcomes by 505 (95% UI, 495-518) TB cases, 55 (95% UI, 51-59) TB deaths, and $32 (95% UI, $24-$40) million in societal costs annually. CONCLUSIONS AND RELEVANCE: In this modeling study of racial and ethnic disparities of TB, these disparities were associated with substantial future health and economic outcomes of TB among US-born persons without interventions beyond current efforts. Actions to eliminate disparities may reduce the excess TB burden among these persons and may contribute to accelerating TB elimination within the US. |
Risk factors underlying racial and ethnic disparities in tuberculosis diagnosis and treatment outcomes, 2011-19: a multiple mediation analysis of national surveillance data
Regan M , Barham T , Li Y , Swartwood NA , Beeler Asay GR , Cohen T , Horsburgh CR Jr , Khan A , Marks SM , Myles RL , Salomon JA , Self JL , Winston CA , Menzies NA . Lancet Public Health 2024 9 (8) e564-e572 BACKGROUND: Despite an overall decline in tuberculosis incidence and mortality in the USA in the past two decades, racial and ethnic disparities in tuberculosis outcomes persist. We aimed to examine the extent to which inequalities in health and neighbourhood-level social vulnerability mediate these disparities. METHODS: We extracted data from the US National Tuberculosis Surveillance System on individuals with tuberculosis during 2011-19. Individuals with multidrug-resistant tuberculosis or missing data on race and ethnicity were excluded. We examined potential disparities in tuberculosis outcomes among US-born and non-US-born individuals and conducted a mediation analysis for groups with a higher risk of treatment incompletion (a summary outcome comprising diagnosis after death, treatment discontinuation, or death during treatment). We used sequential multiple mediation to evaluate eight potential mediators: three comorbid conditions (HIV, end-stage renal disease, and diabetes), homelessness, and four census tract-level measures (poverty, unemployment, insurance coverage, and racialised economic segregation [measured by Index of Concentration at the Extremes(Race-Income)]). We estimated the marginal contribution of each mediator using Shapley values. FINDINGS: During 2011-19, 27 788 US-born individuals and 57 225 non-US-born individuals were diagnosed with active tuberculosis, of whom 27 605 and 56 253 individuals, respectively, met eligibility criteria for our analyses. We did not observe evidence of disparities in tuberculosis outcomes for non-US-born individuals by race and ethnicity. Therefore, subsequent analyses were restricted to US-born individuals. Relative to White individuals, Black and Hispanic individuals had a higher risk of not completing tuberculosis treatment (adjusted relative risk 1·27, 95% CI 1·19-1·35; 1·22, 1·11-1·33, respectively). In multiple mediator analysis, the eight measured mediators explained 67% of the disparity for Black individuals and 65% for Hispanic individuals. The biggest contributors to these disparities for Black individuals and Hispanic individuals were concomitant end-stage renal disease, concomitant HIV, census tract-level racialised economic segregation, and census tract-level poverty. INTERPRETATION: Our findings underscore the need for initiatives to reduce disparities in tuberculosis outcomes among US-born individuals, particularly in highly racially and economically polarised neighbourhoods. Mitigating the structural and environmental factors that lead to disparities in the prevalence of comorbidities and their case management should be a priority. FUNDING: US Centers for Disease Control and Prevention National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention Epidemiologic and Economic Modeling Agreement. |
Tuberculosis disease among nonimmigrant visa holders reported to US Quarantine Stations, January 2011-June 2016
Vonnahme LA , Shaw KM , Gulati RK , Hollberg MR , Posey DL , Regan JJ . J Immigr Minor Health 2024 US-bound immigrants and refugees undergo a mandatory overseas medical examination that includes tuberculosis screening; this exam is not routinely required for temporary visitors applying for non-immigrant visas (NIV) to visit, work, or study in the United States. US health departments and foreign ministries of health report tuberculosis cases in travelers to Centers for Disease Control and Prevention Quarantine Stations. We reviewed cases reported to this passive surveillance system from January 2011 to June 2016. Of 1252 cases of tuberculosis in travelers reported to CDC, 114 occurred in travelers with a long-term NIV. Of these, 83 (73%) were infectious; 18 (16%) with multidrug-resistant tuberculosis (MDR TB) and one with extensively drug-resistant tuberculosis (XDR TB). We found evidence that NIV holders are diagnosed with tuberculosis disease in the United States. Given that long-term NIV holders were over-represented in this data set, despite the small proportion (4%) of overall non-immigrant admissions they represent, expanding the US overseas migration health screening program to this population might be an efficient intervention to further reduce tuberculosis in the United States. |
Effectiveness of COVID-19 vaccines against hospitalisation in Latin America during three pandemic waves, 2021–2022: a test-negative case-control design
Nogareda F , Regan AK , Couto P , Fowlkes AL , Gharpure R , Loayza S , Leite JA , Rodríguez A , Vicari A , Azziz-Baumgartner E , Salas D . Lancet Reg Health Am 2023 27 100626 BACKGROUND: Vaccine effectiveness (VE) is essential to monitor the performance of vaccines and generate strategic information to guide decision making. We pooled data from six Latin American countries to estimate the effectiveness of COVID-19 vaccines in preventing laboratory-confirmed SARS-CoV-2 hospitalisation during three different pandemic waves from February 2021 to September 2022. METHODS: We used a test-negative case-control design in hospitalised adults in Chile, Costa Rica, Ecuador, Guatemala, Paraguay, and Uruguay. We estimated adjusted VE by age group (18-64 and ≥65 years), vaccine type and product for primary series vaccination and booster vaccination and by time since last dose during the Omicron variant dominant period. We used mixed effects logistic regression models adjusting for sex, age, week of onset of symptom onset and pre-existing conditions with country fit as a random effect term. FINDINGS: We included 15,241 severe acute respiratory infection (SARI) patients in the analysis. Among adults 18-64 years, VE estimates for primary series vaccination during pre-Delta and Delta periods ranged by product from 66.5% to 95.1% and from 33.5% to 88.2% for older adults. During the Omicron period, VE estimates for primary series were lower and decreased by time since last vaccination, but VE increased to between 26.4% and 57.4% when a booster was administered. INTERPRETATION: mRNA and viral vector vaccines presented higher VE for both primary series and booster. While VE decreased over time, protection against severe COVID-19-associated hospitalisation increased when booster doses were administered. Vaccination with additional doses should be recommended, particularly for persons at increased risk of developing severe COVID-19. FUNDING: This work was supported by a grant from the U.S. Centers for Disease Control and Prevention (CDC) through cooperative agreements with the Pan American Health Organization/World Health Organization. |
Disparities in tuberculosis incidence by race and ethnicity among the U.S.-born population in the United States, 2011 to 2021 : An analysis of national disease registry data
Li Y , Regan M , Swartwood NA , Barham T , Beeler Asay GR , Cohen T , Hill AN , Horsburgh CR Jr , Khan A , Marks SM , Myles RL , Salomon JA , Self JL , Menzies NA . Ann Intern Med 2024 BACKGROUND: Elevated tuberculosis (TB) incidence rates have recently been reported for racial/ethnic minority populations in the United States. Tracking such disparities is important for assessing progress toward national health equity goals and implementing change. OBJECTIVE: To quantify trends in racial/ethnic disparities in TB incidence among U.S.-born persons. DESIGN: Time-series analysis of national TB registry data for 2011 to 2021. SETTING: United States. PARTICIPANTS: U.S.-born persons stratified by race/ethnicity. MEASUREMENTS: TB incidence rates, incidence rate differences, and incidence rate ratios compared with non-Hispanic White persons; excess TB cases (calculated from incidence rate differences); and the index of disparity. Analyses were stratified by sex and by attribution of TB disease to recent transmission and were adjusted for age, year, and state of residence. RESULTS: In analyses of TB incidence rates for each racial/ethnic population compared with non-Hispanic White persons, incidence rate ratios were as high as 14.2 (95% CI, 13.0 to 15.5) among American Indian or Alaska Native (AI/AN) females. Relative disparities were greater for females, younger persons, and TB attributed to recent transmission. Absolute disparities were greater for males. Excess TB cases in 2011 to 2021 represented 69% (CI, 66% to 71%) and 62% (CI, 60% to 64%) of total cases for females and males, respectively. No evidence was found to indicate that incidence rate ratios decreased over time, and most relative disparity measures showed small, statistically nonsignificant increases. LIMITATION: Analyses assumed complete TB case diagnosis and self-report of race/ethnicity and were not adjusted for medical comorbidities or social determinants of health. CONCLUSION: There are persistent disparities in TB incidence by race/ethnicity. Relative disparities were greater for AI/AN persons, females, and younger persons, and absolute disparities were greater for males. Eliminating these disparities could reduce overall TB incidence by more than 60% among the U.S.-born population. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention. |
Racial and ethnic disparities in diagnosis and treatment outcomes among US-born people diagnosed with tuberculosis, 2003-19: an analysis of national surveillance data
Regan M , Li Y , Swartwood NA , Barham T , Asay GRB , Cohen T , Hill AN , Horsburgh CR , Khan A , Marks SM , Myles RL , Salomon JA , Self JL , Menzies NA . Lancet Public Health 2024 9 (1) e47-e56 BACKGROUND: Persistent racial and ethnic disparities in tuberculosis incidence exist in the USA, however, less is known about disparities along the tuberculosis continuum of care. This study aimed to describe how race and ethnicity are associated with tuberculosis diagnosis and treatment outcomes. METHODS: In this analysis of national surveillance data, we extracted data from the US National Tuberculosis Surveillance System on US-born patients with tuberculosis during 2003-19. To estimate the association between race and ethnicity and tuberculosis diagnosis (diagnosis after death, cavitation, and sputum smear positivity) and treatment outcomes (treatment for more than 12 months, treatment discontinuation, and death during treatment), we fitted log-binomial regression models adjusting for calendar year, sex, age category, and regional division. Race and ethnicity were defined based on US Census Bureau classification as White, Black, Hispanic, Asian, American Indian or Alaska Native, Native Hawaiian or Pacific Islander, and people of other ethnicities. We quantified racial and ethnic disparities as adjusted relative risks (aRRs) using non-Hispanic White people as the reference group. We also calculated the Index of Disparity as a summary measure that quantifies the dispersion in a given outcome across all racial and ethnic groups, relative to the population mean. We estimated time trends in each outcome to evaluate whether disparities were closing or widening. FINDINGS: From 2003 to 2019, there were 72 809 US-born individuals diagnosed with tuberculosis disease of whom 72 369 (35·7% women and 64·3% men) could be included in analyses. We observed an overall higher risk of any adverse outcome (defined as diagnosis after death, treatment discontinuation, or death during treatment) for non-Hispanic Black people (aRR 1·27, 95% CI 1·22-1·32), Hispanic people (1·20, 1·14-1·27), and American Indian or Alaska Native people (1·24, 1·12-1·37), relative to non-Hispanic White people. The Index of Disparity for this summary outcome remained unchanged over the study period. INTERPRETATION: This study, based on national surveillance data, indicates racial and ethnic disparaties among US-born tuberculosis patients along the tuberculosis continuum of care. Initiatives are needed to reduce diagnostic delays and improve treatment outcomes for US-born racially marginalised people in the USA. FUNDING: US Centers for Disease Control and Prevention. |
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. |
Interim effectiveness estimates of 2023 southern hemisphere influenza vaccines in preventing influenza-associated hospitalizations - REVELAC-i Network, March-July 2023
Fowlkes AL , Nogareda F , Regan A , Loayza S , Mancio JM , Duca LM , Couto P , Leite J , Rodriguez A , Salas D , Azziz-Baumgartner E . MMWR Morb Mortal Wkly Rep 2023 72 (37) 1010-1015 What is already known about this topic? | | Effectiveness of seasonal influenza vaccine varies by season and circulating virus type. | | What is added by this report? | | The 2023 Southern Hemisphere seasonal influenza vaccine reduced the risk for influenza-associated hospitalizations by 52%. Circulating influenza viruses were genetically similar to those targeted by the 2023–24 Northern Hemisphere influenza vaccine formulation. This vaccine might offer similar protection if these viruses predominate during the coming Northern Hemisphere influenza season. | | What are the implications for public health practice? | | Vaccination remains one of the most effective ways to protect against influenza-associated complications. In anticipation of Northern Hemisphere influenza virus circulation, CDC recommends that health authorities encourage U.S. health care providers to administer seasonal influenza vaccine to all eligible persons aged ≥6 months. |
Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods (preprint)
Smith ER , Oakley E , He S , Zavala R , Ferguson K , Miller L , Grandner GW , Abejirinde IO , Afshar Y , Ahmadzia H , Aldrovandi G , Akelo V , Tippett Barr BA , Bevilacqua E , Brandt JS , Broutet N , Fernández Buhigas I , Carrillo J , Clifton R , Conry J , Cosmi E , Delgado-López C , Divakar H , Driscoll AJ , Favre G , Flaherman V , Gale C , Gil MM , Godwin C , Gottlieb S , Hernandez Bellolio O , Kara E , Khagayi S , Kim CR , Knight M , Kotloff K , Lanzone A , Le Doare K , Lees C , Litman E , Lokken EM , Laurita Longo V , Magee LA , Martinez-Portilla RJ , McClure E , Metz TD , Money D , Mullins E , Nachega JB , Panchaud A , Playle R , Poon LC , Raiten D , Regan L , Rukundo G , Sanin-Blair J , Temmerman M , Thorson A , Thwin S , Tolosa JE , Townson J , Valencia-Prado M , Visentin S , von Dadelszen P , Adams Waldorf K , Whitehead C , Yang H , Thorlund K , Tielsch JM . medRxiv 2022 2020.11.08.20228056 We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.Competing Interest StatementClare Whitehead declares a a relationship with the following entities, Ferring Pharmaceuticals COVID19 Investigational, Grant, NHMRC Fellowship (salary support). Alice Panchaud declares the following research grants to institution: H2020-Grant (Consortium member of Innovative medicine initiative call 13 topic 9) (ConcePTION), Efficacy and safety studies on Medicines EMA/2017/09/PE/11, Lot 4, WP 2 lead (CONSIGN: Study on impact of COVID-19 infection and medicines in pregnancy), Safety monitoring of COVID-19 vaccines in the EU Reopening of competition no. 20 under a framework contract following procurement procedure EMA/2017/09/PE (Lot 3) 4. Federal Office of Public Health (207000 CHF). (The COVI-Preg registry). Edward Mullins declares a relationship with the following entities National Institute for Health Research (Project grant for PAN COVID study) Deborah Money declares a relationship with the following entities, Canadian Institutes of Health Research (payments to my institution only), Public Health Agency of Canada (payments to my institution only), BC Womens Foundation (payments to my institution only) and is a Member of the COVID-19 Immunity Task Force sponsored by the Canadian government. Torri D. Metz declares a relationship with the following entities, Pfizer (site Principal Investigator for SARS-CoV-2 vaccination in pregnancy study, money paid to institution and member of Medical Advisory Board for SARS-CoV-2 vaccination in pregnancy study, money paid to me), NICHD (subcommittee Chair for the NICHD Maternal-Fetal Medicine Units Network Gestational Research Assessments of COVID-19 (GRAVID) study), and Society for Maternal-Fetal Medicine (board member). Erica Lokken declares a relationship with the following entity, US NIH (paid institution). Karen L. Kotloff declares a relationship with the following entity, Bill and Melinda Gates Foundation. Siran He declares a relationship with the following entity, Bill and Melinda Gates Foundtion (payments made to my institution). Valerie Flaherman declares a relationship with the following entities, Bill and Melinda Gates Foundation (payments to my institution), Yellow Chair Foundati n (payments to my institution), Robert Woods Johnson Foundation (payments to my institution), CDC Foundation, California Health Care Foundation (payments to my institution), Tara Health Foundation (payments to my institution), UCSF Womens Health Center of Excellence (payments to my institution) and California Department of Health Care Services (payments made to my institution). Jose Sanin-Blair declares a relationship with the following entity, Ferring Pharmaceuticals which give a grant ($10,000) for the expenses of RECOGEST trial and is a part of the Columbian Federation of Perinatology Yalda Afshar declares a relationship with the following entities, Bill and Melinda Gates Foundation (payments made to my institution), CDC Foundation (payments made to my institution), Robert Woods Johnson Foundation (payments made to my institution), and UCLA Deans Office COVID-19 research (payments made to my institution). Rebecca Cliffton declares a relationship with the following entity, NIH HD36801 (MFMU Network DCC).Clinical TrialPROSPERO ID: 188955Funding StatementFunded by the Bill & Melinda Gates Foundation grant to Emily Smith (INV-022057) at George Washington University and a grant to Emily Smith via a grant from the Bill & Melinda Gates Foundation to Stephanie Gaw (INV-017035) at University of California San Francisco.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This is a protocol paper and thus exempt from ethical approval. Ultimately, the meta-analysis study is exempt from human research ethics approval as the study authors will be synthesizing de-identified or aggregate data.I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesThis is a protocol paper and there is no related data to share. |
Value profile for respiratory syncytial virus vaccines and monoclonal antibodies
Fleming JA , Baral R , Higgins D , Khan S , Kochar S , Li Y , Ortiz JR , Cherian T , Feikin D , Jit M , Karron RA , Limaye RJ , Marshall C , Munywoki PK , Nair H , Newhouse LC , Nyawanda BO , Pecenka C , Regan K , Srikantiah P , Wittenauer R , Zar HJ , Sparrow E . Vaccine 2023 41 Suppl 2 S7-S40 Respiratory syncytial virus (RSV) is the predominant cause of acute lower respiratory infection (ALRI) in young children worldwide, yet no licensed RSV vaccine exists to help prevent the millions of illnesses and hospitalizations and tens of thousands of young lives taken each year. Monoclonal antibody (mAb) prophylaxis exists for prevention of RSV in a small subset of very high-risk infants and young children, but the only currently licensed product is impractical, requiring multiple doses and expensive for the low-income settings where the RSV disease burden is greatest. A robust candidate pipeline exists to one day prevent RSV disease in infant and pediatric populations, and it focuses on two promising passive immunization approaches appropriate for low-income contexts: maternal RSV vaccines and long-acting infant mAbs. Licensure of one or more candidates is feasible over the next one to three years and, depending on final product characteristics, current economic models suggest both approaches are likely to be cost-effective. Strong coordination between maternal and child health programs and the Expanded Program on Immunization will be needed for effective, efficient, and equitable delivery of either intervention. This 'Vaccine Value Profile' (VVP) for RSV is intended to provide a high-level, holistic assessment of the information and data that are currently available to inform the potential public health, economic and societal value of pipeline vaccines and vaccine-like products. This VVP was developed by a working group of subject matter experts from academia, non-profit organizations, public private partnerships and multi-lateral organizations, and in collaboration with stakeholders from the WHO headquarters. All contributors have extensive expertise on various elements of the RSV VVP and collectively aimed to identify current research and knowledge gaps. The VVP was developed using only existing and publicly available information. |
End-of-season influenza vaccine effectiveness during the Southern Hemisphere 2022 Influenza Season - Chile, Paraguay, and Uruguay
Chard AN , Nogareda F , Regan AK , Barraza MFO , Fasce RA , Vergara N , Avendaño M , Penayo E , Vázquez C , Von Horoch M , Michel F , Alfonso A , Mogdasy C , Chiparelli H , Goñi N , Alegretti M , Loayza S , Couto P , Rodriguez A , Salas D , Fowlkes AL , Azziz-Baumgartner E . Int J Infect Dis 2023 134 39-44 OBJECTIVE: To estimate the 2022 end-of-season influenza vaccine effectiveness (VE) against severe acute respiratory illness (SARI) hospitalization in Chile, Paraguay, and Uruguay. METHODS: We pooled surveillance data from SARI cases in 18 sentinel surveillance hospitals in Chile (n=9), Paraguay (n=2), and Uruguay (n=7) during March 16-November 30, 2022. VE was estimated using a test-negative design and logistic regression models adjusted for country, age, sex, presence of ≥1 comorbidity, and week of illness onset. VE estimates were stratified by influenza virus type and subtype (when available) and influenza vaccine target population, categorized as children, individuals with comorbidities, and older adults, defined per countries' national immunization policies. RESULTS: Among the 3,147 SARI cases, there were 382 (12.1%) influenza test-positive case-patients; 328 (85.9%) influenza case-patients were in Chile, 33 (8.6%) were in Paraguay, and 21 (5.5%) were in Uruguay. In all countries, the predominant subtype was influenza A(H3N2) (92.6% of influenza cases). Adjusted VE against any influenza-associated SARI hospitalization was 33.8% (95% CI: 15.3%, 48.2%); VE against influenza A(H3N2)-associated SARI hospitalization was 30.4% (95% CI: 10.1%, 46.0%). VE estimates were similar across target populations. CONCLUSION: During the 2022 influenza season, influenza vaccination reduced the odds of hospitalization among those vaccinated by one-third. Health officials should encourage influenza vaccination in accordance with national recommendations. |
Isolation and quarantine for COVID-19 in the United States, 2020-2022
Oeltmann JE , Vohra D , Matulewicz HH , DeLuca N , Smith JP , Couzens C , Lash RR , Harvey B , Boyette M , Edwards A , Talboy PM , Dubose O , Regan P , Loosier P , Caruso E , Katz DJ , Taylor MM , Moonan PK . Clin Infect Dis 2023 77 (2) 212-219 BACKGROUND: Public health programs varied in ability to reach people with COVID-19 and their contacts to encourage separation from others. For both adult cases of COVID-19 and contacts, we estimated the impact of contact tracing activities on separation behaviors from January, 2020 until March, 2022. METHODS: We used a probability-based panel survey of a nationally representative sample to gather data for estimates and comparisons. RESULTS: An estimated 64,255,351 adults reported a positive SARS-CoV-2 test result; 79.6% isolated for >5 days, 60.2% isolated for >10 days, and 79.2% self-notified contacts. 24,057,139 (37.7%) completed a case investigation and 46.2% reported contacts to health officials. More adults who completed a case investigation isolated than adults who did not (>5 days, 82.6%; >10 days, 69.8% versus >5 days, 78.2% and >10 days 54.8%; p-values for both measures <0.05).84,946,636 adults were a contact to a COVID-19 case; 73.1% learned of their exposure directly from a case; 49.4% quarantined for >5 days, 18.7% quarantined for >14 days, and 13.5% completed a contact tracing call. More who completed a contact tracing call quarantined than those who did not (>5 days, 61.2%; >14 days, 25.2% versus >5 days, 48.5%; >14 days, 18.0%; p-values for both measures <0.05). CONCLUSIONS: Engagement in contact tracing positively correlated with isolation and quarantine. However, most adults with COVID-19 isolated and self-notified contacts regardless of whether the public health workforce was able to reach them. Identifying and reaching contacts was challenging, and limited the ability to promote quarantining, and testing. |
Perceived benefits and barriers of a COVID-19 test to stay program in a school district serving Black or African American people with low income, December 2021
Kamitani E , Holman EJ , Philpott D , Parasram VD , Ruth LJ , Onyeuku C , Carter B , Gwynn E , Beck TW , Regan K , Hagler LR , Clark A , Shelley G , Thomas ES . Public Health Rep 2023 333549231155472 OBJECTIVES: Quarantine after exposure to COVID-19 has resulted in substantial loss of in-person learning in schools from prekindergarten through grade 12. Test to Stay (TTS), a strategy that limits the spread of SARS-CoV-2 while prioritizing in-person learning, requires substantial investment in resources. The objective of this study was to assess the perceived benefits, barriers, and facilitators of implementing TTS in an urban school district in the Midwest serving primarily Black or African American people with low income. METHODS: In December 2021, we used a concurrent mixed-methods approach to understand perceived benefits, barriers, and facilitators of implementing TTS by combining quantitative analysis of telephone surveys conducted with parents (n = 124) and a qualitative inquiry involving key informants from the school district and local health department (n = 22). We analyzed quantitative data using descriptive statistics. We used thematic analysis to analyze qualitative data. RESULTS: Quantitative findings showed that parents supported TTS because it was convenient (n = 83, 97%) and effective (n = 82, 95%) in keeping students learning in person (n = 82, 95%) and preventing the spread of COVID-19 (n = 80, 93%). Qualitative interviews with informants found that having a clear protocol and assigning staff to specified tasks allowed for successful TTS implementation. However, insufficient staffing and testing resources, parent mistrust of testing, and lack of communication from schools were perceived barriers. CONCLUSION: The school community strongly supported TTS despite the many implementation challenges faced. This study emphasized the importance of ensuring resources for equitable implementation of COVID-19 prevention strategies and the critical role of communication. |
Adverse maternal, fetal, and newborn outcomes among pregnant women with SARS-CoV-2 infection: an individual participant data meta-analysis
Smith ER , Oakley E , Grandner GW , Ferguson K , Farooq F , Afshar Y , Ahlberg M , Ahmadzia H , Akelo V , Aldrovandi G , Tippett Barr BA , Bevilacqua E , Brandt JS , Broutet N , Fernández Buhigas I , Carrillo J , Clifton R , Conry J , Cosmi E , Crispi F , Crovetto F , Delgado-López C , Divakar H , Driscoll AJ , Favre G , Flaherman VJ , Gale C , Gil MM , Gottlieb SL , Gratacós E , Hernandez O , Jones S , Kalafat E , Khagayi S , Knight M , Kotloff K , Lanzone A , Le Doare K , Lees C , Litman E , Lokken EM , Laurita Longo V , Madhi SA , Magee LA , Martinez-Portilla RJ , McClure EM , Metz TD , Miller ES , Money D , Moungmaithong S , Mullins E , Nachega JB , Nunes MC , Onyango D , Panchaud A , Poon LC , Raiten D , Regan L , Rukundo G , Sahota D , Sakowicz A , Sanin-Blair J , Söderling J , Stephansson O , Temmerman M , Thorson A , Tolosa JE , Townson J , Valencia-Prado M , Visentin S , von Dadelszen P , Adams Waldorf K , Whitehead C , Yassa M , Tielsch JM . BMJ Glob Health 2023 8 (1) INTRODUCTION: Despite a growing body of research on the risks of SARS-CoV-2 infection during pregnancy, there is continued controversy given heterogeneity in the quality and design of published studies. METHODS: We screened ongoing studies in our sequential, prospective meta-analysis. We pooled individual participant data to estimate the absolute and relative risk (RR) of adverse outcomes among pregnant women with SARS-CoV-2 infection, compared with confirmed negative pregnancies. We evaluated the risk of bias using a modified Newcastle-Ottawa Scale. RESULTS: We screened 137 studies and included 12 studies in 12 countries involving 13 136 pregnant women.Pregnant women with SARS-CoV-2 infection-as compared with uninfected pregnant women-were at significantly increased risk of maternal mortality (10 studies; n=1490; RR 7.68, 95% CI 1.70 to 34.61); admission to intensive care unit (8 studies; n=6660; RR 3.81, 95% CI 2.03 to 7.17); receiving mechanical ventilation (7 studies; n=4887; RR 15.23, 95% CI 4.32 to 53.71); receiving any critical care (7 studies; n=4735; RR 5.48, 95% CI 2.57 to 11.72); and being diagnosed with pneumonia (6 studies; n=4573; RR 23.46, 95% CI 3.03 to 181.39) and thromboembolic disease (8 studies; n=5146; RR 5.50, 95% CI 1.12 to 27.12).Neonates born to women with SARS-CoV-2 infection were more likely to be admitted to a neonatal care unit after birth (7 studies; n=7637; RR 1.86, 95% CI 1.12 to 3.08); be born preterm (7 studies; n=6233; RR 1.71, 95% CI 1.28 to 2.29) or moderately preterm (7 studies; n=6071; RR 2.92, 95% CI 1.88 to 4.54); and to be born low birth weight (12 studies; n=11 930; RR 1.19, 95% CI 1.02 to 1.40). Infection was not linked to stillbirth. Studies were generally at low or moderate risk of bias. CONCLUSIONS: This analysis indicates that SARS-CoV-2 infection at any time during pregnancy increases the risk of maternal death, severe maternal morbidities and neonatal morbidity, but not stillbirth or intrauterine growth restriction. As more data become available, we will update these findings per the published protocol. |
Severity of influenza illness by seasonal influenza vaccination status among hospitalised patients in four South American countries, 2013-19: a surveillance-based cohort study
Regan AK , Arriola CS , Couto P , Duca L , Loayza S , Nogareda F , de Almeida WAF , Antman J , Araya S , Avendaño Vigueras MA , Battaglia Paredes SC , Brstilo IF , Bustos P , Fandiño ME , Fasce R , Giovacchini CM , González Caro CI , von Horoch M , Del Valle Juarez M , Katz N , Olivares MF , da Silva DA , da Silva ET , Sotomayor V , Vergara N , Azziz-Baumgartner E , Ropero AM . Lancet Infect Dis 2022 23 (2) 222-232 BACKGROUND: Although several studies have reported attenuated influenza illness following influenza vaccination, results have been inconsistent and have focused predominantly on adults in the USA. This study aimed to evaluate the severity of influenza illness by vaccination status in a broad range of influenza vaccine target groups across multiple South American countries. METHODS: We analysed data from four South American countries (Argentina, Brazil, Chile, and Paraguay) participating in REVELAC-i, a multicentre, test-negative design, vaccine effectiveness network including 41 sentinel hospitals. Individuals hospitalised at one of these centres with severe acute respiratory infection were tested for influenza by real-time RT-PCR, and were included in the analysis if they had complete information about their vaccination status and outcomes of their hospital stay. We used multivariable logistic regression weighted by inverse probability of vaccination and adjusted for antiviral use, duration of illness before admission, and calendar week, to calculate the adjusted odds ratios (aORs) of intensive care unit (ICU) admission and in-hospital death (and combinations of these outcomes) among influenza-positive patients by vaccination status for three target groups: young children (aged 6-24 months), adults (aged 18-64 years) with pre-existing health conditions, and older adults (aged ≥65 years). Survival curves were used to compare length of hospital stay by vaccination status in each target group. FINDINGS: 2747 patients hospitalised with PCR-confirmed influenza virus infection between Jan 1, 2013, and Dec 8, 2019, were included in the study: 649 children (70 [10·8%] fully vaccinated, 193 [29·7%] partially vaccinated) of whom 87 (13·4%) were admitted to ICU and 12 (1·8%) died in hospital; 520 adults with pre-existing medical conditions (118 [22·7%] vaccinated), of whom 139 (26·7%) were admitted to ICU and 55 (10·6%) died in hospital; and 1578 older adults (609 [38·6%] vaccinated), of whom 271 (17·2%) were admitted to ICU and 220 (13·9%) died in hospital. We observed earlier discharge among partially vaccinated children (adjusted hazard ratio 1·14 [95% CI 1·01-1·29]), fully vaccinated children (1·24 [1·04-1·47]), and vaccinated adults with pre-existing medical conditions (1·78 [1·18-2·69]) compared with their unvaccinated counterparts, but not among vaccinated older adults (0·82 [0·65-1·04]). Compared with unvaccinated individuals, lower odds of ICU admission were found for partially vaccinated children (aOR 0·64 [95% CI 0·44-0·92]) and fully vaccinated children (0·52 [0·28-0·98]), but not for adults with pre-existing conditions (1·25 [0·93-1·67]) or older adults (0·88 [0·72-1·08]). Lower odds of in-hospital death (0·62 [0·50-0·78]) were found in vaccinated versus unvaccinated older adults, with or without ICU admission, but did not differ significantly in partially vaccinated (1·35 [0·57-3·20]) or fully vaccinated young children (0·88 [0·16-4·82]) or adults with pre-existing medical conditions (1·09 [0·73-1·63]) compared with the respective unvaccinated patient groups. INTERPRETATION: Influenza vaccination was associated with illness attenuation among those hospitalised with influenza, although results differed by vaccine target group. These findings might suggest that attenuation of disease severity might be specific to certain target groups, seasons, or settings. FUNDING: US Centers for Disease Control and Prevention. TRANSLATIONS: For the Spanish and Portuguese translations of the abstract see Supplementary Materials section. |
Clinical risk factors of adverse outcomes among women with COVID-19 in the pregnancy and postpartum period: A sequential, prospective meta-analysis.
Smith ER , Oakley E , Grandner GW , Rukundo G , Farooq F , Ferguson K , Baumann S , Waldorf KA , Afshar Y , Ahlberg M , Ahmadzia H , Akelo V , Aldrovandi G , Bevilacqua E , Bracero N , Brandt JS , Broutet N , Carrillo J , Conry J , Cosmi E , Crispi F , Crovetto F , Gil MDM , Delgado-Lpez C , Divakar H , Driscoll AJ , Favre G , Buhigas IF , Flaherman V , Gale C , Godwin CL , Gottlieb S , Gratacs E , He S , Hernandez O , Jones S , Joshi S , Kalafat E , Khagayi S , Knight M , Kotloff K , Lanzone A , Longo VL , LeDoare K , Lees C , Litman E , Lokken EM , Madhi SA , Magee LA , Martinez-Portilla RJ , Metz TD , Miller ES , Money D , Moungmaithong S , Mullins E , Nachega JB , Nunes MC , Onyango D , Panchaud A , Poon LC , Raiten D , Regan L , Sahota D , Sakowicz A , Sanin-Blair J , Stephansson O , Temmerman M , Thorson A , Thwin SS , TippettBarr BA , Tolosa JE , Tug N , Valencia-Prado M , Visentin S , vonDadelszen P , Whitehead C , Wood M , Yang H , Zavala R , Tielsch JM . Am J Obstet Gynecol 2022 228 (2) 161-177 OBJECTIVE: This sequential, prospective meta-analysis (sPMA) sought to identify risk factors among pregnant and postpartum women with COVID-19 for adverse outcomes related to: disease severity, maternal morbidities, neonatal mortality and morbidity, adverse birth outcomes. DATA SOURCES: We prospectively invited study investigators to join the sPMA via professional research networks beginning in March 2020. STUDY ELIGIBILITY CRITERIA: Eligible studies included those recruiting at least 25 consecutive cases of COVID-19 in pregnancy within a defined catchment area. STUDY APPRAISAL AND SYNTHESIS METHODS: We included individual patient data from 21 participating studies. Data quality was assessed, and harmonized variables for risk factors and outcomes were constructed. Duplicate cases were removed. Pooled estimates for the absolute and relative risk of adverse outcomes comparing those with and without each risk factor were generated using a two-stage meta-analysis. RESULTS: We collected data from 33 countries and territories, including 21,977 cases of SARS-CoV-2 infection in pregnancy or postpartum. We found that women with comorbidities (pre-existing diabetes, hypertension, cardiovascular disease) versus those without were at higher risk for COVID-19 severity and pregnancy health outcomes (fetal death, preterm birth, low birthweight). Participants with COVID-19 and HIV were 1.74 times (95% CI: 1.12, 2.71) more likely to be admitted to the ICU. Pregnant women who were underweight before pregnancy were at higher risk of ICU admission (RR 5.53, 95% CI: 2.27, 13.44), ventilation (RR 9.36, 95% CI: 3.87, 22.63), and pregnancy-related death (RR 14.10, 95% CI: 2.83, 70.36). Pre-pregnancy obesity was also a risk factor for severe COVID-19 outcomes including ICU admission (RR 1.81, 95% CI: 1.26,2.60), ventilation (RR 2.05, 95% CI: 1.20,3.51), any critical care (RR 1.89, 95% CI: 1.28,2.77), and pneumonia (RR 1.66, 95% CI: 1.18,2.33). Anemic pregnant women with COVID-19 also had increased risk of ICU admission (RR 1.63, 95% CI: 1.25, 2.11) and death (RR 2.36, 95% CI: 1.15, 4.81). CONCLUSION: We found that pregnant women with comorbidities including diabetes, hypertension, and cardiovascular disease were at increased risk for severe COVID-19-related outcomes, maternal morbidities, and adverse birth outcomes. We also identified several less commonly-known risk factors, including HIV infection, pre-pregnancy underweight, and anemia. Although pregnant women are already considered a high-risk population, special priority for prevention and treatment should be given to pregnant women with these additional risk factors. |
Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.
Smith ER , Oakley E , He S , Zavala R , Ferguson K , Miller L , Grandner GW , Abejirinde IO , Afshar Y , Ahmadzia H , Aldrovandi G , Akelo V , Tippett Barr BA , Bevilacqua E , Brandt JS , Broutet N , Fernández Buhigas I , Carrillo J , Clifton R , Conry J , Cosmi E , Delgado-López C , Divakar H , Driscoll AJ , Favre G , Flaherman V , Gale C , Gil MM , Godwin C , Gottlieb S , Hernandez Bellolio O , Kara E , Khagayi S , Kim CR , Knight M , Kotloff K , Lanzone A , Le Doare K , Lees C , Litman E , Lokken EM , Laurita Longo V , Magee LA , Martinez-Portilla RJ , McClure E , Metz TD , Money D , Mullins E , Nachega JB , Panchaud A , Playle R , Poon LC , Raiten D , Regan L , Rukundo G , Sanin-Blair J , Temmerman M , Thorson A , Thwin S , Tolosa JE , Townson J , Valencia-Prado M , Visentin S , von Dadelszen P , Adams Waldorf K , Whitehead C , Yang H , Thorlund K , Tielsch JM . PLoS One 2022 17 (6) e0270150 We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis. |
Consistency of self-reported and documented historical influenza vaccination status of US healthcare workers
Regan AK , Wesley MG , Gaglani M , Kim SS , Edwards LJ , Murthy K , Jeddy Z , Naleway AL , Flannery B , Dawood FS , Groom H . Influenza Other Respir Viruses 2022 16 (5) 881-890 BACKGROUND: Healthcare personnel (HCP) are a priority group for annual influenza vaccination. Few studies have assessed the validity of recall of prior influenza vaccination status among HCP, especially for more than one preceding season. METHODS: Using data from a randomized controlled trial of influenza vaccination among 947 HCP from two US healthcare systems, we assessed agreement between participant self-report and administrative record documentation of influenza vaccination status during the preceding five influenza seasons; kappa coefficients and sensitivity values were calculated. Administrative record documentation was considered the gold standard. Documented vaccination sources included electronic medical records, employee health records, outside immunization providers, and the state immunization information system. RESULTS: Among 683 HCP with prior influenza immunization information, 89.7% (95% CI: 87.2%, 91.9%) of HCP were able to self-report their vaccination status for the season preceding the survey. By the fifth preceding season, 82.6% (95% CI: 79.5%, 85.3%) of HCP were able to self-report. Among HCP who self-reported their vaccination status, agreement between self-report and documented vaccination status ranged from 81.9% (95% CI: 77.2%, 86.7%) for the fifth season to 90.5% (95% CI: 87.2%, 93.9%) for the season preceding interview. HCP who received vaccine for only some of the preceding five seasons (18.3%) more commonly had 2 errors in their recall compared with those vaccinated all five preceding seasons (55.7% vs. 4.3%). CONCLUSIONS: Self-reported vaccination status is a reliable source for historical influenza vaccination information among HCP who are consistently vaccinated but less reliable for those with a history of inconsistent vaccination. |
Adverse Birth Outcomes Associated With Prepregnancy and Prenatal Electronic Cigarette Use
Regan AK , Bombard JM , O'Hegarty MM , Smith RA , Tong VT . Obstet Gynecol 2021 138 (1) 85-94 OBJECTIVE: To evaluate the risk of adverse birth outcomes among adults who use electronic cigarettes (e-cigarettes) before and during pregnancy. METHODS: Data from the 2016-2018 PRAMS (Pregnancy Risk Assessment Monitoring System) were used to assess the association between e-cigarette use during the 3 months before and last 3 months of pregnancy among 79,176 individuals with a recent live birth and the following birth outcomes: preterm birth, small for gestational age, and low birth weight (LBW). Adjusted prevalence ratios were generated using average marginal predictions from multivariable logistic regression models. Models were stratified by prenatal combustible cigarette smoking and frequency of e-cigarette use (daily or less than daily use). RESULTS: In the 3 months before pregnancy, 2.7% (95% CI 2.6-2.9%) of respondents used e-cigarettes; 1.1% (95% CI 1.0-1.2%) used e-cigarettes during the last 3 months of pregnancy. Electronic cigarette use before pregnancy was not associated with adverse birth outcomes. Electronic cigarette use during pregnancy was associated with increased prevalence of LBW compared with nonuse (8.1% vs 6.1%; adjusted prevalence ratio 1.33; 95% CI 1.06-1.66). Among respondents who did not also smoke combustible cigarettes during pregnancy (n=72,256), e-cigarette use was associated with higher prevalence of LBW (10.6%; adjusted prevalence ratio 1.88; 95% CI 1.38-2.57) and preterm birth (12.4%; adjusted prevalence ratio 1.69; 95% CI 1.20-2.39). When further stratified by frequency of e-cigarette use, associations were seen only for daily users. CONCLUSION: E-cigarette use during pregnancy, particularly when used daily by individuals who do not also smoke combustible cigarettes, is associated with adverse birth outcomes. |
Cruise ship travel in the era of COVID-19: A summary of outbreaks and a model of public health interventions.
Guagliardo SAJ , Prasad PV , Rodriguez A , Fukunaga R , Novak RT , Ahart L , Reynolds J , Griffin I , Wiegand R , Quilter LAS , Morrison S , Jenkins K , Wall HK , Treffiletti A , White SB , Regan J , Tardivel K , Freeland A , Brown C , Wolford H , Johansson MA , Cetron MS , Slayton RB , Friedman CR . Clin Infect Dis 2021 74 (3) 490-497 BACKGROUND: Cruise travel contributed to SARS-CoV-2 transmission when there were relatively few cases in the United States. By March 14, 2020, the Centers for Disease Control and Prevention (CDC) issued a No Sail Order suspending U.S. cruise operations; the last U.S. passenger ship docked on April 16. METHODS: We analyzed SARS-CoV-2 outbreaks on cruises in U.S. waters or carrying U.S. citizens and used regression models to compare voyage characteristics. We used compartmental models to simulate the potential impact of four interventions (screening for COVID-19 symptoms; viral testing on two days and isolation of positive persons; reduction of passengers by 40%, crew by 20%, and port visits to one) for 7-day and 14-day voyages. RESULTS: During January 19-April 16, 2020, 89 voyages on 70 ships had known SARS-CoV-2 outbreaks; 16 ships had recurrent outbreaks. There were 1,669 RT-PCR-confirmed SARS-CoV-2 infections and 29 confirmed deaths. Longer voyages were associated with more cases (adjusted incidence rate ratio, 1.10, 95% CI: 1.03-1.17, p < 0.0001). Mathematical models showed that 7-day voyages had about 70% fewer cases than 14-day voyages. On 7-day voyages, the most effective interventions were reducing the number of individuals onboard (43-49% reduction in total infections) and testing passengers and crew (42-43% reduction in total infections). All four interventions reduced transmission by 80%, but no single intervention or combination eliminated transmission. Results were similar for 14-day voyages. CONCLUSIONS: SARS-CoV-2 outbreaks on cruises were common during January-April 2020. Despite all interventions modeled, cruise travel still poses a significant SARS-CoV-2 transmission risk. |
An international cohort study of birth outcomes associated with hospitalized acute respiratory infection during pregnancy
Regan AK , Feldman B , Azziz-Baumgartner E , Naleway AL , Williams J , Wyant BE , Simmonds K , Effler PV , Booth S , Ball SW , Katz MA , Fink RV , Thompson MG , Chung H , Kwong JC , Fell DB . J Infect 2020 81 (1) 48-56 OBJECTIVES: Findings during the 2009 pandemic suggest severe maternal infection with pandemic influenza had adverse perinatal health consequences. Limited data exist evaluating the perinatal health effects of severe seasonal influenza and non-influenza infections during pregnancy. METHODS: A retrospective cohort of pregnant women from Australia, Canada, Israel, and the United States was established using birth records to identify pregnancies and birth outcomes and hospital and laboratory testing records to identify influenza and non-influenza associated acute respiratory or febrile illness (ARFI) hospitalizations. ARFI hospitalized women were matched to non-hospitalized women (1:4) by country and season of conception. Log-binomial logistic regression was used to estimate the relative risk (aRR) of preterm birth (PTB), small-for-gestational-age (SGA), and low birthweight (LBW) birth, adjusting for pre-existing medical conditions, maternal age, and parity. RESULTS: 950 pregnant women hospitalized with an ARFI were matched with 3,800 non-hospitalized pregnant women. Compared to non-hospitalized women, risk of PTB was greater among women hospitalized with influenza-associated ARFI (aRR: 1.57; 95% CI: 1.15-2.15) and non-influenza ARFI (aRR: 2.78; 95% CI: 2.12-3.65). Similar results were observed for LBW; there were no associations with SGA birth. CONCLUSIONS: ARFI hospitalization during pregnancy was associated with increased risk of PTB and LBW. |
Public Health Responses to COVID-19 Outbreaks on Cruise Ships - Worldwide, February-March 2020.
Moriarty LF , Plucinski MM , Marston BJ , Kurbatova EV , Knust B , Murray EL , Pesik N , Rose D , Fitter D , Kobayashi M , Toda M , Canty PT , Scheuer T , Halsey ES , Cohen NJ , Stockman L , Wadford DA , Medley AM , Green G , Regan JJ , Tardivel K , White S , Brown C , Morales C , Yen C , Wittry B , Freeland A , Naramore S , Novak RT , Daigle D , Weinberg M , Acosta A , Herzig C , Kapella BK , Jacobson KR , Lamba K , Ishizumi A , Sarisky J , Svendsen E , Blocher T , Wu C , Charles J , Wagner R , Stewart A , Mead PS , Kurylo E , Campbell S , Murray R , Weidle P , Cetron M , Friedman CR . MMWR Morb Mortal Wkly Rep 2020 69 (12) 347-352 An estimated 30 million passengers are transported on 272 cruise ships worldwide each year* (1). Cruise ships bring diverse populations into proximity for many days, facilitating transmission of respiratory illness (2). SARS-CoV-2, the virus that causes coronavirus disease (COVID-19) was first identified in Wuhan, China, in December 2019 and has since spread worldwide to at least 187 countries and territories. Widespread COVID-19 transmission on cruise ships has been reported as well (3). Passengers on certain cruise ship voyages might be aged >/=65 years, which places them at greater risk for severe consequences of SARS-CoV-2 infection (4). During February-March 2020, COVID-19 outbreaks associated with three cruise ship voyages have caused more than 800 laboratory-confirmed cases among passengers and crew, including 10 deaths. Transmission occurred across multiple voyages of several ships. This report describes public health responses to COVID-19 outbreaks on these ships. COVID-19 on cruise ships poses a risk for rapid spread of disease, causing outbreaks in a vulnerable population, and aggressive efforts are required to contain spread. All persons should defer all cruise travel worldwide during the COVID-19 pandemic. |
Epidemiology and clinical outcomes of hospitalizations for acute respiratory or febrile illness and laboratory-confirmed influenza among pregnant women during six influenza seasons, 2010-2016
Dawood FS , Garg S , Fink RV , Russell ML , Regan AK , Katz MA , Booth S , Chung H , Klein NP , Kwong JC , Levy A , Naleway A , Riesel D , Thompson MG , Wyant BE , Fell DB . J Infect Dis 2019 221 (10) 1703-1712 BACKGROUND: Pregnant women are at increased risk of seasonal influenza hospitalizations, but data about the epidemiology of severe influenza among pregnant women remain largely limited to pandemics. METHODS: To describe the epidemiology of hospitalizations for acute respiratory infection or febrile illness (ARFI) and influenza-associated ARFI among pregnant women, administrative and electronic health record data were analyzed from retrospective cohorts of pregnant women hospitalized with ARFI who had testing for influenza viruses by RT-PCR in Australia, Canada, Israel and the United States during 2010-2016. RESULTS: Of 18,048 ARFI-coded hospitalizations, 1,064 (6%) included RT-PCR testing for influenza viruses, of which 614 (58%) were influenza-positive. Of 614 influenza-positive ARFI hospitalizations, 35% were in women with low socioeconomic status, 20% with underlying conditions, and 67% in their third trimesters. The median length of influenza-positive hospitalizations was 2 days (IQR 1-4), 18% (95% confidence interval (CI) 15-21%) resulted in delivery, 10% (95% CI 8-12%) included a pneumonia diagnosis, 5% (95% CI 3-6%) required intensive care, 2% (95% CI 1-3%) included a sepsis diagnosis, and <1% (95% CI 0-1%) resulted in respiratory failure. CONCLUSIONS: Our findings characterize seasonal influenza hospitalizations among pregnant women and can inform assessments of the public health and economic impact of seasonal influenza on pregnant women. |
Effect of firefighting intervention on occupant tenability during a residential fire
Kerber S , Regan JW , Horn GP , Fent KW , Smith DL . Fire Technol 2019 55 (6) 2289-2316 This study examines the impact of firefighting intervention on occupant tenability to provide actionable guidance for selecting firefighting tactics that are based upon empirical rather than anecdotal evidence. Twelve fire experiments were conducted utilizing a full-sized residential structure to assess the impact of firefighting tactics on occupant exposure. Six groups of firefighters, recruited from fire departments throughout the country, participated in two experiments each. Two attack tactics were examined: (1) interior attack—water applied from the interior while a search team searched for simulated trapped occupants, and (2) transitional attack—exterior water application before transitioning to the interior while a search team searched for simulated trapped occupants. Gas concentration and temperature measurements were analyzed using a fractional effective dose (FED) approach to determine the impact of firefighter tactics on the exposure for potential trapped occupants. Water application by the fire attack teams resulted in a rapid drop in temperatures throughout the structure, followed shortly afterward by a decrease in the FED rate. There was no significant difference between the magnitude of the temperature decrease or the time until the inflection point in the FED curve between transitional attack and interior attack. As the removal time for the occupant increased, the toxic exposure to the occupant increased, despite the decreasing FED rate due to suppression. Occupant tenability analysis showed that the most threatened occupants are not always closest to the seat of the fire, while occupants near the fire but behind closed doors may have received a low exposure. As such, the results emphasized the need for rapid removal of occupants and coordination of suppression and ventilation tactics to limit toxic exposures. |
A report of activities related to the Dietary Reference Intakes from the Joint Canada-US Dietary Reference Intakes Working Group
MacFarlane AJ , Cogswell ME , de Jesus JM , Greene-Finestone LS , Klurfeld DM , Lynch CJ , Regan K , Yamini S . Am J Clin Nutr 2019 109 (2) 251-259 The governments of the United States and Canada have jointly undertaken the development of the Dietary Reference Intakes (DRIs) since the mid-1990s. The Federal DRI committees from each country work collaboratively to identify DRI needs, prioritize nutrient reviews, advance work to resolve methodological issues that is necessary for new reviews, and sponsor DRI-related committees through the National Academies of Sciences, Engineering and Medicine. In recent years, the Joint Canada-US DRI Working Group, consisting of members from both Federal DRI committees, developed an open and transparent nomination process for prioritizing nutrients for DRI review, by which sodium, the omega-3 (n-3) fatty acids, vitamin E, and magnesium were identified. In addition, discussions during the nutrient nomination process prompted the Federal DRI committees to address previously identified issues related to the use of chronic disease endpoints when setting DRIs. The development of guiding principles for setting DRIs based on chronic disease risk reduction will be applied for the first time during the DRI review of sodium and potassium. In summary, the US and Canadian governments have worked collaboratively to adapt our approach to prioritizing nutrients for DRI review and to broaden the scope of the DRIs to better incorporate the concept of chronic disease risk reduction in order to improve public health. |
Estimating vaccine effectiveness against hospitalized influenza during pregnancy: Multicountry protocol for a retrospective cohort study
Naleway AL , Ball S , Kwong JC , Wyant BE , Katz MA , Regan AK , Russell ML , Klein NP , Chung H , Simmonds KA , Azziz-Baumgartner E , Feldman BS , Levy A , Fell DB , Drews SJ , Garg S , Effler P , Barda N , Irving SA , Shifflett P , Jackson ML , Thompson MG . JMIR Res Protoc 2019 8 (1) e11333 BACKGROUND: Although pregnant women are believed to have elevated risks of severe influenza infection and are targeted for influenza vaccination, no study to date has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy, primarily because this outcome poses many methodological challenges. OBJECTIVE: The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) was formed in 2016 as an international collaboration with the Centers for Disease Control and Prevention; Abt Associates; and study sites in Australia, Canada, Israel, and the United States. The primary goal of this collaboration is to estimate IVE in preventing acute respiratory or febrile illness (ARFI) hospitalizations associated with laboratory-confirmed influenza virus infection during pregnancy. Secondary aims include (1) describing the incidence, clinical course, and severity of influenza-associated ARFI hospitalization during pregnancy; (2) comparing the characteristics of ARFI-hospitalized pregnant women who were tested for influenza with those who were not tested; (3) describing influenza vaccination coverage in pregnant women; and (4) comparing birth outcomes among women with laboratory-confirmed influenza-associated hospitalization versus other noninfluenza ARFI hospitalizations. METHODS: For an initial assessment of IVE, sites identified a retrospective cohort of pregnant women aged from 18 to 50 years whose pregnancies overlapped with local influenza seasons from 2010 to 2016. Pregnancies were defined as those that ended in a live birth or stillbirth of at least 20 weeks gestation. The analytic sample for the primary IVE analysis was restricted to pregnant women who were hospitalized for ARFI during site-specific influenza seasons and clinically tested for influenza virus infection using real-time reverse transcription polymerase chain reaction. RESULTS: We identified approximately 2 million women whose pregnancies overlapped with influenza seasons; 550,344 had at least one hospitalization during this time. After restricting to women who were hospitalized for ARFI and tested for influenza, the IVE analytic sample included 1005 women. CONCLUSIONS: In addition to addressing the primary question about the effectiveness of influenza vaccination, PREVENT data will address other important knowledge gaps including understanding the incidence, clinical course, and severity of influenza-related hospitalizations during pregnancy. The data infrastructure and international partnerships created for these analyses may be useful and informative for future influenza studies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11333. |
Influenza vaccine effectiveness in preventing influenza-associated hospitalizations during pregnancy: A multi-country retrospective test negative design study, 2010-2016
Thompson MG , Kwong JC , Regan AK , Katz MA , Drews SJ , Azziz-Baumgartner E , Klein NP , Chung H , Effler PV , Feldman BS , Simmonds K , Wyant BE , Dawood FS , Jackson ML , Fell DB , Levy A , Barda N , Svenson LW , Fink RV , Ball SW , Naleway A . Clin Infect Dis 2018 68 (9) 1444-1453 Background: To date, no study has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy. Methods: The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) consisted of public health or healthcare systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and the United States (California, Oregon, and Washington). Sites identified pregnant women aged 18 through 50 years whose pregnancies overlapped with local influenza seasons from 2010 through 2016. Administrative data were used to identify hospitalizations with acute respiratory or febrile illness (ARFI) and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for influenza viruses. Overall IVE was estimated using the test-negative design and adjusting for site, season, season timing, and high-risk medical conditions. Results: Among 19450 hospitalizations with an ARFI discharge diagnosis (across 25 site-specific study seasons), only 1030 (6%) of the pregnant women were tested for influenza viruses by rRT-PCR. Approximately half of these women had pneumonia or influenza discharge diagnoses (54%). Influenza A or B virus infections were detected in 598/1030 (58%) of the ARFI hospitalizations with influenza testing. Across sites and seasons, 13% of rRT-PCR-confirmed influenza-positive pregnant women were vaccinated compared with 22% of influenza-negative pregnant women; the adjusted overall IVE was 40% (95% confidence interval = 12%-59%) against influenza-associated hospitalization during pregnancy. Conclusion: Between 2010 and 2016, influenza vaccines offered moderate protection against laboratory-confirmed influenza-associated hospitalizations during pregnancy, which may further inform the benefits of maternal influenza vaccination programs. |
Maritime varicella illness and death reporting, U.S., 2010-2015
Rice ME , Bannerman M , Marin M , Lopez AS , Lewis MM , Stamatakis CE , Regan JJ . Travel Med Infect Dis 2018 23 27-33 BACKGROUND: Ships destined for, or departing from, U.S. ports of entry must report certain signs and symptoms of potentially communicable diseases of public health interest among travelers to the Division of Global Migration and Quarantine (DGMQ) at the Centers for Disease Control and Prevention. METHODS: We reviewed ships' varicella case and outbreak reports from January 2010 through December 2015. RESULTS: DGMQ received 967 reports of varicella and 13 reports of herpes zoster. Most varicella case-patients were 20-49 years of age (84.7%, 472/557) and were cruise ship crew members (78.4%, 758/967). Most often, cruise ship crew member case-patients were born in or held passports from Indonesia (21.7%, 80/369), Philippines (17.6%, 65/369), or India (17.3%, 64/369). Ninety-nine varicella outbreaks were reported, including 439 varicella cases and one herpes zoster case; 97 (98.0%) outbreaks occurred on cruise ships, and 90.2% of associated cases were among crew members (397/440). Most varicella cases were in crew members, who are adults often from tropical regions where varicella immunity is acquired later in childhood or young adulthood or without varicella vaccination programs. CONCLUSION: Varicella vaccination as appropriate for susceptible travelers, particularly crew members, before maritime travel may decrease risk of varicella infection and prevent outbreaks on ships. |
Respiratory syncytial virus hospitalization during pregnancy in four high-income countries, 2010-2016
Regan AK , Klein NP , Langley G , Drews SJ , Buchan S , Ball S , Kwong JC , Naleway A , Thompson M , Wyant BE , Levy A , Chung H , Feldman B , Katz M . Clin Infect Dis 2018 67 (12) 1915-1918 Few studies have addressed respiratory syncytial virus (RSV) infection during pregnancy. Among 846 pregnant women hospitalized with respiratory illness and tested for RSV, 21 (2%) were RSV positive, of whom 8 (38%) were diagnosed with pneumonia. Despite study limitations, these data can help inform decisions about RSV prevention strategies. |
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