Last data update: Dec 02, 2024. (Total: 48272 publications since 2009)
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Query Trace: Carter RJ[original query] |
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Using regression tree analysis to examine demographic and geographic characteristics of COVID-19 vaccination trends over time, United States, May 2021-April 2022, National Immunization Survey Adult COVID Module
Earp M , Meng L , Black CL , Carter RJ , Lu PJ , Singleton JA , Chorba T . Vaccine 2024 42 (26) 126372 Using data from the nationally representative National Immunization Survey (NIS), we applied conditional linear regression tree methodology to examine relationships between demographic and geographic factors and propensity of receiving various doses of COVID-19 vaccine over time; these analyses identified temporal changes in these relationships that heretofore had not been identified using conventional logistical regression methodologies. Three regression tree models were built using an R package, Recursive Partitioning for Modeling Survey (rpms), to examine propensities over time of receiving a (1) first dose of a two-dose COVID-19 mRNA primary vaccination series or single dose of the Janssen vaccine (vaccine initiation), (2) primary series completion, and (3) monovalent booster dose, using a conditional linear effect model. Persons ≥50 years were more likely to complete a primary series and receive a first booster dose; persons reporting having received non-COVID-19 vaccines recently were more likely to initiate vaccination, complete the primary series, and get a first booster dose; persons reporting having work or school requirements were more likely to complete the primary series. Persons not reporting having received non-COVID-19 vaccines in 2 years but reporting having work or school vaccination requirements were more likely to initiate vaccination than those without work/school requirements. Among persons not reporting having received non-COVID-19 vaccines in 2 years and not reporting having work or school vaccination requirements, those aged ≥50 years were more likely to initiate vaccination than were younger adults. Propensity of receiving various doses was correlated with age, having recently received non-COVID 19 vaccines, and having vaccination requirements at work or school. Regression tree methodology enabled modeling of different COVID-19 vaccination dose propensities as a linear effect of time, revealed changes in relationships over time between demographic factors and propensity of receipt of different doses, and identified populations that may benefit from vaccination outreach efforts. |
Health and economic benefits of routine childhood immunizations in the era of the vaccines for children program - United States, 1994-2023
Zhou F , Jatlaoui TC , Leidner AJ , Carter RJ , Dong X , Santoli JM , Stokley S , Daskalakis DC , Peacock G . MMWR Morb Mortal Wkly Rep 2024 73 (31) 682-685 Since 1994, the U.S. Vaccines for Children (VFC) program has covered the cost of vaccines for children whose families might not otherwise be able to afford vaccines. This report assessed and quantified the health benefits and economic impact of routine U.S. childhood immunizations among both VFC-eligible and non-VFC-eligible children born during 1994-2023. Diphtheria and tetanus toxoids and acellular pertussis vaccine; Haemophilus influenzae type b conjugate vaccine; oral and inactivated poliovirus vaccines; measles, mumps, and rubella vaccine; hepatitis B vaccine; varicella vaccine; pneumococcal conjugate vaccine; hepatitis A vaccine; and rotavirus vaccine were included. Averted illnesses and deaths and associated costs over the lifetimes of 30 annual cohorts of children born during 1994-2023 were estimated using established economic models. Net savings were calculated from the payer and societal perspectives. Among approximately 117 million children born during 1994-2023, routine childhood vaccinations will have prevented approximately 508 million lifetime cases of illness, 32 million hospitalizations, and 1,129,000 deaths, at a net savings of $540 billion in direct costs and $2.7 trillion in societal costs. From both payer and societal perspectives, routine childhood vaccinations among children born during 1994-2023 resulted in substantial cost savings. Childhood immunizations continue to provide substantial health and economic benefits, while promoting health equity. |
Monkeypox virus infections after 2 preexposure doses of JYNNEOS vaccine - United States, May 2022-May 2024
Guagliardo SAJ , Kracalik I , Carter RJ , Braden C , Free R , Hamal M , Tuttle A , McCollum AM , Rao AK . MMWR Morb Mortal Wkly Rep 2024 73 (20) 460-466 Two doses of JYNNEOS vaccine are effective in preventing many mpox cases and can reduce the severity of symptoms in infected persons. However, infections among fully vaccinated persons can occur. During May 2022-May 2024, a total of 271 mpox cases among fully vaccinated persons were reported to CDC from 27 U.S. jurisdictions. These reported infections are estimated to have occurred in <1% of fully vaccinated persons. Compared with cases among unvaccinated persons, infections among fully vaccinated persons were more likely to occur among non-Hispanic White men aged 30-39 years, were associated with increased numbers of sexual partners, and resulted in less severe disease (p<0.001). Among infections in fully vaccinated persons with complete data, infections after vaccination were reported more commonly after receipt of heterologous (subcutaneous and intradermal) (46%) or homologous subcutaneous (32%) JYNNEOS vaccination than after homologous intradermal (22%) vaccination. Disparate time intervals from vaccination to infection among fully vaccinated persons suggest that immunity is not waning. The median interval between the second vaccine dose and illness onset was longer for cases among persons who had received 2 intradermal doses (median = 363 days; IQR = 221-444 days) compared with cases in persons who had received 2 subcutaneous doses (median = 263 days; IQR = 47-334 days) (p<0.001). The implications of this finding are not known; however, these data should increase confidence in the effectiveness of vaccine doses that were administered intradermally, the preferred method of administration during the peak of the outbreak when vaccine supply was limited. Persons recommended to receive the JYNNEOS vaccine should receive 2 doses, irrespective of the route of administration, and at this time, additional doses are not recommended for the affected population. |
Sociodemographic trends and correlation between parental hesitancy towards pediatric COVID-19 vaccines and routine childhood immunizations in the United States: 2021-2022 National Immunization Survey-Child COVID Module
Olusanya OA , Masters NB , Zhang F , Sugerman DE , Carter RJ , Weiss D , Singleton JA . Vaccines (Basel) 2024 12 (5) Multiple factors may influence parental vaccine hesitancy towards pediatric COVID-19 vaccines and routine childhood immunizations (RCIs). Using the United States National Immunization Survey-Child COVID Module data collected from parents/guardians of children aged 5-11 years, this cross-sectional study (1) identified the trends and prevalence estimates of parental hesitancy towards pediatric COVID-19 vaccines and RCIs, (2) examined the relationship between hesitancy towards pediatric COVID-19 vaccines and RCIs, and (3) assessed trends in parental hesitancy towards RCIs by sociodemographic characteristics and behavioral and social drivers of COVID-19 vaccination. From November 2021 to July 2022, 54,329 parents or guardians were interviewed. During this 9-month period, the proportion of parents hesitant about pediatric COVID-19 vaccines increased by 15.8 percentage points (24.8% to 40.6%). Additionally, the proportion of parents who reported RCIs hesitancy increased by 4.7 percentage points from November 2021 to May 2022 but returned to baseline by July 2022. Over nine months, parents' concerns about pediatric COVID-19 infections declined; however, parents were increasingly worried about pediatric COVID-19 vaccine safety and overall importance. Furthermore, pediatric COVID-19 vaccine hesitancy was more prevalent among parents of children who were White (43.2%) versus Black (29.3%) or Hispanic (26.9%) and those residing in rural (51.3%) compared to urban (28.9%) areas. In contrast, RCIs hesitancy was higher among parents of children who were Black (32.0%) versus Hispanic (24.5%) or White (23.6%). Pediatric COVID-19 vaccine hesitancy was 2-6 times as prevalent among parents who were RCIs hesitant compared to those who were RCIs non-hesitant. This positive correlation between parental hesitancy towards pediatric COVID-19 vaccines and RCIs was observed for all demographic and psychosocial factors for unadjusted and adjusted prevalence ratios. Parent-provider interactions should increase vaccine confidence, shape social norms, and facilitate behavior change to promote pediatric vaccination rates. |
An overview of the COVID-19 pediatric vaccine program - The U.S. experience vaccinating children ages 6 months through 17 years
Chatham-Stephens K , Carter RJ , Duggar C , Woodworth KR , Carnes CA , Bhatt A , Ottis C , Voegeli C , Stokley S , Vogt T . Vaccine 2024 COVID-19 vaccination decreases risk for COVID-19 illness and severe disease in children, including multisystem inflammatory syndrome (MIS-C) and death. On December 13, 2020, CDC recommended COVID-19 vaccination for persons ages ≥16 years, with expansion on May 12, 2021, to adolescents ages 12-15 years; to children ages 5-11 years on November 2, 2021; and to children ages 6 months-4 years on June 18, 2022. Following each age-specific recommendation, the U.S. government collaborated with state and local governments, vaccine manufacturers, and numerous other public and private entities, to ensure rapid, broad, and equitable COVID-19 vaccine distribution to strategic locations across the country to maximize access. However, vaccination coverage among children has been lower than among adults and lower among younger children than adolescents. As of May 10, 2023, COVID-19 primary series vaccination coverage was 61.8% among U.S. children ages 12-17 years, 32.9% among those ages 5-11 years, and 5.5% among those ages 6 months-4 years. This manuscript describes the planning and implementation of the U.S. COVID-19 pediatric vaccine program, including successes (e.g., the availability of pharmacy vaccination to extend access beyond more traditional pediatric vaccine providers) and challenges (e.g., multi-dose vaccine vials instead of single-dose vials, leading to concerns about wastage) to provide a historical record of the program and to help inform planning and implementation of future routine or pandemic-related pediatric vaccination campaigns. |
Public perceptions of Ebola vaccines and confidence in health services to treat Ebola, malaria, and tuberculosis: Findings from a cross-sectional household survey in Uganda, 2020
Koyuncu A , Carter RJ , Musaazi J , Namageyo-Funa A , Carter VM , Lamorde M , Prybylski D , Apondi R , Bakyaita T , Boore AL , Homsy J , Brown VR , Kigozi J , Nabaggala MS , Nakate V , Nkurunziza E , Stowell DF , Walwema R , Olowo A , Jalloh MF . PLOS Glob Public Health 2023 3 (12) e0001884 Uganda used Ebola vaccines as part of its preparedness and response during the 2018-2020 10th Ebola virus disease (EVD) outbreak in neighboring Democratic Republic of the Congo (DRC). We evaluated the public's perceptions of Ebola vaccines and compared their confidence in health services to treat Ebola versus malaria and tuberculosis as part of a survey on Ebola knowledge, attitudes, and practices (KAP) conducted in March 2020. A cross-sectional household survey was implemented in six districts in Uganda using multi-stage cluster sampling to randomly select participants. The districts were purposively selected from districts classified by the government as at high- or low-risk for an EVD outbreak. We describe perceptions of Ebola vaccines and confidence in health services to treat Ebola, tuberculosis, and malaria. Modified Poisson regression modeling was used to identify the demographic correlates of these outcomes. Among 3,485 respondents, 18% were aware of Ebola vaccines. Of those, 92% agreed that the vaccines were needed to prevent Ebola. Participants aged 15-24 years were 4% more likely to perceive such need compared to those 60 years and older (adjusted prevalence ratio [aPR] 1.04, 95% confidence interval [CI] 1.0-1.08). The perceived need was 5% lower among participants with at least some secondary education compared to uneducated participants (aPR 0.95; 0.92-0.99). Overall, 81% of those aware of the vaccines believed that everyone or most people in their community would get vaccinated if offered, and 94% said they would likely get vaccinated if offered. Confidence in health services to treat Ebola was lower compared to treating malaria or tuberculosis (55% versus 93% and 77%, respectively). However, participants from the EVD high-risk districts were 22% more likely to be confident in health services to treat Ebola compared to those in low-risk districts (aPR: 1.22; 95% CI: 1.08, 1.38). Our findings suggest that intent to take an Ebola vaccine during an outbreak was strong, but more work needs to be done to increase public awareness of these vaccines. The public's high confidence in health services to treat other health threats, such as malaria and tuberculosis, offer building blocks for strengthening their confidence in health services to treat EVD in the event of an outbreak. |
Reducing vaccination disparities during a national emergency response: The US mpox vaccine equity pilot program
Bautista GJ , Madera-Garcia V , Carter RJ , Schwitters A , Byrkit R , Carnes N , Prejean J . J Public Health Manag Pract 2023 30 (1) 122-129 CONTEXT: In response to the first reported mpox cases in May 2022, the US government implemented plans to bring testing, treatment, and vaccines to communities disproportionately affected by mpox-including the population of men who have sex with men (MSM) and Black/African American and Hispanic/Latino men, 2 subpopulations experiencing vaccination disparities. We describe the development and implementation of the US Mpox Vaccine Equity Pilot Program (MVEPP), characteristics of completed vaccination projects, and challenges that occurred. We also discuss opportunities for reducing vaccination disparities in future outbreaks. PROGRAM: To address reported vaccination disparities, the US government launched MVEPP in 2 phases. Phase 1 centered around public events attended by large numbers of gay, bisexual, and other MSM, such as Pride festivals. Phase 2 asked health departments to propose mpox vaccination projects specifically aimed at reducing or eliminating racial/ethnic and other demographic disparities in mpox vaccination. IMPLEMENTATION: MVEPP received 35 vaccination project proposals. We analyzed data from 22 completed projects that resulted in 25 675 doses of JYNNEOS administered. We note 3 innovative strategies that were implemented in several projects: direct collaboration with organizations providing services to MSM and transgender women; implementation of MVEPP projects in unique nonclinical community settings and at venues frequented by MSM and transgender women; and offering an array of services as part of mpox vaccination projects, rather than offering only mpox vaccination. EVALUATION: MVEPP highlighted the importance of recognizing and working to eliminate racial/ethnic and other disparities in access to medical countermeasures during a public health emergency. Jurisdictions developed and implemented innovative strategies to bring mpox vaccination and related services to communities disproportionately affected by mpox-including MSM and the subpopulations of Black/African American and Hispanic/Latino MSM. Lessons learned from MVEPP may inform efforts to reduce disparities during future public health responses. |
Employer Requirements and COVID-19 Vaccination and Attitudes among Healthcare Personnel in the U.S.: Findings from National Immunization Survey Adult COVID Module, August - September 2021 (preprint)
Lee JT , Hu SS , Zhou T , Bonner K , Kriss JL , Wilhelm E , Carter RJ , Holmes C , de Perio MA , Lu PJ , Nguyen KH , Brewer NT , Singleton JA . medRxiv 2022 15 Introduction Employer vaccination requirements have been used to increase vaccination uptake among healthcare personnel (HCP). In summer 2021, HCP were the group most likely to have employer requirements for COVID-19 vaccinations as healthcare facilities led the implementation of such requirements. This study examined the association between employer requirements and HCP's COVID-19 vaccination status and attitudes about the vaccine. Methods Participants were a national representative sample of United States (US) adults who completed the National Immunization Survey Adult COVID Module (NIS-ACM) during August-September 2021. Respondents were asked about COVID-19 vaccination and intent, requirements for vaccination, place of work, attitudes surrounding vaccinations, and sociodemographic variables. This analysis focused on HCP respondents. We first calculated the weighted proportion reporting COVID-19 vaccination for HCP by sociodemographic variables. Then we computed unadjusted and adjusted prevalence ratios for vaccination coverage and key indicators on vaccine attitudes, comparing HCP based on individual self-report of vaccination requirements. Results Of 12,875 HCP respondents, 41.5% reported COVID-19 vaccination employer requirements. Among HCP with vaccination requirements, 90.5% had been vaccinated against COVID-19, as compared to 73.3% of HCP without vaccination requirements-a pattern consistent across sociodemographic groups. Notably, the greatest differences in uptake between HCP with and without employee requirements were seen in sociodemographic subgroups with the lowest vaccination uptake, e.g., HCP aged 18-29 years, HCP with high school or less education, HCP living below poverty, and uninsured HCP. In every sociodemographic subgroup examined, vaccine uptake was more equitable among HCP with vaccination requirements than in HCP without. Finally, HCP with vaccination requirements were also more likely to express confidence in the vaccine's safety (68.3% vs. 60.1%) and importance (89.6% vs 79.6%). Conclusion In a large national US sample, employer requirements were associated with higher and more equitable HCP vaccination uptake across all sociodemographic groups examined. Our findings suggest that employer requirements can contribute to improving COVID-19 vaccination coverage, similar to patterns seen for other vaccines. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Potential for recurrent mpox outbreaks among gay, bisexual, and other men who have sex with men - United States, 2023
Pollock ED , Clay PA , Keen A , Currie DW , Carter RJ , Quilter LAS , Gundlapalli AV , Mermin J , Spicknall IH . MMWR Morb Mortal Wkly Rep 2023 72 (21) 568-573 More than 30,000 monkeypox (mpox) cases have been diagnosed in the United States since May 2022, primarily among gay, bisexual, and other men who have sex with men (MSM) (1,2). In recent months, diagnoses have declined to one case per day on average. However, mpox vaccination coverage varies regionally, suggesting variable potential risk for mpox outbreak recurrence (3). CDC simulated dynamic network models representing sexual behavior among MSM to estimate the risk for and potential size of recurrent mpox outbreaks at the jurisdiction level for 2023 and to evaluate the benefits of vaccination for preparedness against mpox reintroduction. The risk for outbreak recurrence after mpox reintroduction is linearly (inversely) related to the proportion of MSM who have some form of protective immunity: the higher the population prevalence of immunity (from vaccination or natural infection), the lower the likelihood of recurrence in that jurisdiction across all immunity levels modeled. In contrast, the size of a potential recurrent outbreak might have thresholds: very small recurrences are predicted for jurisdictions with mpox immunity of 50%-100%; exponentially increasing sizes of recurrences are predicted for jurisdictions with 25%-50% immunity; and linearly increasing sizes of recurrences are predicted for jurisdictions with <25% immunity. Among the 50 jurisdictions examined, 15 are predicted to be at minimal risk for recurrence because of their high levels of population immunity. This analysis underscores the ongoing need for accessible and sustained mpox vaccination to decrease the risk for and potential size of future mpox recurrences. |
The CDC domestic mpox response - United States, 2022-2023
McQuiston JH , Braden CR , Bowen MD , McCollum AM , McDonald R , Carnes N , Carter RJ , Christie A , Doty JB , Ellington S , Fehrenbach SN , Gundlapalli AV , Hutson CL , Kachur RE , Maitland A , Pearson CM , Prejean J , Quilter LAS , Rao AK , Yu Y , Mermin J . MMWR Morb Mortal Wkly Rep 2023 72 (20) 547-552 Monkeypox (mpox) is a serious viral zoonosis endemic in west and central Africa. An unprecedented global outbreak was first detected in May 2022. CDC activated its emergency outbreak response on May 23, 2022, and the outbreak was declared a Public Health Emergency of International Concern on July 23, 2022, by the World Health Organization (WHO),* and a U.S. Public Health Emergency on August 4, 2022, by the U.S. Department of Health and Human Services.(†) A U.S. government response was initiated, and CDC coordinated activities with the White House, the U.S. Department of Health and Human Services, and many other federal, state, and local partners. CDC quickly adapted surveillance systems, diagnostic tests, vaccines, therapeutics, grants, and communication systems originally developed for U.S. smallpox preparedness and other infectious diseases to fit the unique needs of the outbreak. In 1 year, more than 30,000 U.S. mpox cases were reported, more than 140,000 specimens were tested, >1.2 million doses of vaccine were administered, and more than 6,900 patients were treated with tecovirimat, an antiviral medication with activity against orthopoxviruses such as Variola virus and Monkeypox virus. Non-Hispanic Black (Black) and Hispanic or Latino (Hispanic) persons represented 33% and 31% of mpox cases, respectively; 87% of 42 fatal cases occurred in Black persons. Sexual contact among gay, bisexual, and other men who have sex with men (MSM) was rapidly identified as the primary risk for infection, resulting in profound changes in our scientific understanding of mpox clinical presentation, pathogenesis, and transmission dynamics. This report provides an overview of the first year of the response to the U.S. mpox outbreak by CDC, reviews lessons learned to improve response and future readiness, and previews continued mpox response and prevention activities as local viral transmission continues in multiple U.S. jurisdictions (Figure). |
Characteristics of the moveable middle: Opportunities among adults open to COVID-19 vaccination
Omari A , Boone KD , Zhou T , Lu PJ , Kriss JL , Hung MC , Carter RJ , Black C , Weiss D , Masters NB , Lee JT , Brewer NT , Szilagyi PG , Singleton JA . Am J Prev Med 2023 64 (5) 734-741 INTRODUCTION: Focusing on subpopulations that express the intention to receive a COVID-19 vaccination but are unvaccinated may improve the yield of COVID-19 vaccination efforts. METHODS: A nationally representative sample of 789,658 U.S. adults aged 18 years participated in the National Immunization Survey Adult COVID Module from May 2021 to April 2022. The survey assessed respondents' COVID-19 vaccination status and intent by demographic characteristics (age, urbanicity, educational attainment, region, insurance, income, and race/ethnicity). This study compared composition and within-group estimates of those who responded that they definitely or probably will get vaccinated or are unsure (moveable middle) from the first and last month of data collection. RESULTS: Because vaccination uptake increased over the study period, the moveable middle declined among persons aged 18 years. Adults aged 18-39 years and suburban residents comprised most of the moveable middle in April 2022. Groups with the largest moveable middles in April 2022 included persons with no insurance (10%), those aged 18-29 years (8%), and those with incomes below poverty (8%), followed by non-Hispanic Native Hawaiian or other Pacific Islander (7%), non-Hispanic multiple or other race (6%), non-Hispanic American Indian or Alaska Native persons (6%), non-Hispanic Black or African American persons (6%), those with below high school education (6%), those with high school education (5%), and those aged 30-39 years (5%). CONCLUSIONS: A sizable percentage of adults open to receiving COVID-19 vaccination remain in several demographic groups. Emphasizing engagement of persons who are unvaccinated in some racial/ethnic groups, aged 18-39 years, without health insurance, or with lower income may reach more persons open to vaccination. |
JYNNEOS Vaccination Coverage Among Persons at Risk for Mpox - United States, May 22, 2022-January 31, 2023
Owens LE , Currie DW , Kramarow EA , Siddique S , Swanson M , Carter RJ , Kriss JL , Boersma PM , Lee FC , Spicknall I , Hurley E , Zlotorzynska M , Gundlapalli AV . MMWR Morb Mortal Wkly Rep 2023 72 (13) 342-347 From May 2022 through the end of January 2023, approximately 30,000 cases of monkeypox (mpox) have been reported in the United States and >86,000 cases reported internationally.* JYNNEOS (Modified Vaccinia Ankara vaccine, Bavarian Nordic) is recommended for subcutaneous administration to persons at increased risk for mpox (1,2) and has been demonstrated to provide protection against infection (3-5). To increase the total number of vaccine doses available, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on August 9, 2022, recommending administration of the vaccine intradermally (0.1 mL per dose) for persons aged ≥18 years who are recommended to receive it (6); intradermal administration can generate an equivalent immune response to that achieved through subcutaneous injection using approximately one fifth the subcutaneous dose (7). CDC analyzed JYNNEOS vaccine administration data submitted to CDC from jurisdictional immunization information systems (IIS)(†) to assess the impact of the EUA and to estimate vaccination coverage among the population at risk for mpox. During May 22, 2022-January 31, 2023, a total of 1,189,651 JYNNEOS doses (734,510 first doses and 452,884 second doses)(§) were administered. Through the week of August 20, 2022, the predominant route of administration was subcutaneous, after which intradermal administration became predominant, in accordance with FDA guidance. As of January 31, 2023, 1-dose and 2-dose (full vaccination) coverage among persons at risk for mpox is estimated to have reached 36.7% and 22.7%, respectively. Despite a steady decline in mpox cases from a 7-day daily average of more than 400 cases on August 1, 2022, to five cases on January 31, 2023, vaccination for persons at risk for mpox continues to be recommended (1). Targeted outreach and continued access to and availability of mpox vaccines to persons at risk are important to help prevent and minimize the impact of a resurgence of mpox. |
Vaccines for children provider practices in the COVID-19 vaccination program: Barriers to participation, intentions to offer COVID-19 vaccination to children aged <5 years, and vaccination promotion, United States, March 2022
Kang Y , Zhang F , Chatham-Stephens K , Carter RJ , Vogt T . Clin Pediatr (Phila) 2023 99228231161335 The aim of the study was to assess barriers to Vaccines for Children (VFC) provider practices participating in the COVID-19 Vaccination Program and intentions to offer COVID-19 vaccination to children aged <5 years. We invited a random sample of 15 000 VFC provider practices in the United States to complete an online survey during February 28 to March 11, 2022. Of 2809 practices that completed the survey, 2246 (80.0%) were enrolled in the COVID-19 Vaccination Program. Concerns around staff resources, vaccine and supply storage space, and vaccine wastage from multidose vials were the most frequently reported program-enrollment barriers. Among enrolled practices that have decided whether to offer COVID-19 vaccination to the children aged <5 years, 1641 (88.8% of 1848) reported likely offering it to current patients, and 1165 reported likely offering it to children who are not current patients. Addressing participation barriers and encouraging active promotion may increase COVID-19 vaccination coverage of children. |
Behavioral and social drivers of COVID-19 vaccination in the United States, August-November 2021
Bonner KE , Vashist K , Abad NS , Kriss JL , Meng L , Lee JT , Wilhelm E , Lu PJ , Carter RJ , Boone K , Baack B , Masters NB , Weiss D , Black C , Huang Q , Vangala S , Albertin C , Szilagyi PG , Brewer NT , Singleton JA . Am J Prev Med 2023 INTRODUCTION: COVID-19 vaccines are safe, effective, and widely available, but many adults in the U.S. have not been vaccinated for COVID-19. This study examined the associations between behavioral and social drivers of vaccination with COVID-19 vaccine uptake in the U.S. adults and their prevalence by region. METHODS: A nationally representative sample of U.S. adults participated in a cross-sectional telephone survey in August-November 2021; the analysis was conducted in January 2022. Survey questions assessed self-reported COVID-19 vaccine initiation, demographics, and behavioral and social drivers of vaccination. RESULTS: Among the 255,763 respondents, 76% received their first dose of COVID-19 vaccine. Vaccine uptake was higher among respondents aged ≥75 years (94%), females (78%), and Asian non-Hispanic people (94%). The drivers of vaccination most strongly associated with uptake included higher anticipated regret from nonvaccination, risk perception, and confidence in vaccine safety and importance, followed by work- or school-related vaccination requirements, social norms, and provider recommendation (all p<0.05). The direction of association with uptake varied by reported level of difficulty in accessing vaccines. The prevalence of all of these behavioral and social drivers of vaccination was highest in the Northeast region and lowest in the Midwest and South. CONCLUSIONS: This nationally representative survey found that COVID-19 vaccine uptake was most strongly associated with greater anticipated regret, risk perception, and confidence in vaccine safety and importance, followed by vaccination requirements and social norms. Interventions that leverage these social and behavioral drivers of vaccination have the potential to increase COVID-19 vaccine uptake and could be considered for other vaccine introductions. |
Geographic Heterogeneity in Behavioral and Social Drivers of COVID-19 Vaccination.
Masters NB , Zhou T , Meng L , Lu PJ , Kriss JL , Black C , Omari A , Boone K , Weiss D , Carter RJ , Brewer NT , Singleton JA . Am J Prev Med 2022 63 (6) 883-893 INTRODUCTION: Little is known about how the drivers of COVID-19 vaccination vary across the U.S. To inform vaccination outreach efforts, this study explores geographic variation in correlates of COVID-19 nonvaccination among adults. METHODS: Participants were a nationally representative sample of U.S. adults identified through random-digit dialing for the National Immunization Survey-Adult COVID Module. Analyses examined the geographic and temporal landscape of constructs in the Behavioral and Social Drivers of Vaccination Framework among unvaccinated respondents from May 2021 to December 2021 (n=531,798) and sociodemographic and geographic disparities and Behavioral and Social Drivers of Vaccination predictors of COVID-19 nonvaccination from October 2021 to December 2021 (n=187,756). RESULTS: National coverage with at least 1 dose of COVID-19 vaccine was 79.3% by December 2021, with substantial geographic heterogeneity. Regions with the largest proportion of unvaccinated persons who would probably get a COVID-19 vaccine or were unsure resided in the Southeast and Midwest (Health and Human Services Regions 4 and 5). Both regions had similar temporal trends regarding concerns about COVID-19 and confidence in vaccine importance, although the Southeast had especially low confidence in vaccine safety in December 2021, lowest in Florida (5.5%) and highest in North Carolina (18.0%). The strongest Behavioral and Social Drivers of Vaccination correlate of not receiving a COVID-19 vaccination was lower confidence in COVID-19 vaccine importance (adjusted prevalence ratio=5.19, 95% CI=4.93, 5.47; strongest in the Northeast, Southwest, and Mountain West and weakest in the Southeast and Midwest). Other Behavioral and Social Drivers of Vaccination correlates also varied by region. CONCLUSIONS: Contributors to nonvaccination showed substantial geographic heterogeneity. Strategies to improve COVID-19 vaccination uptake may need to be tailored regionally. |
Receipt of first and second doses of JYNNEOS vaccine for prevention of monkeypox - United States, May 22-October 10, 2022
Kriss JL , Boersma PM , Martin E , Reed K , Adjemian J , Smith N , Carter RJ , Tan KR , Srinivasan A , McGarvey S , McGehee J , Henderson D , Aleshire N , Gundlapalli AV . MMWR Morb Mortal Wkly Rep 2022 71 (43) 1374-1378 Vaccination with JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic) to prevent monkeypox commenced shortly after confirmation of the first monkeypox case in the current outbreak in the United States on May 17, 2022 (1). To date, more than 27,000 cases have been reported across all 50 states, the District of Columbia (DC), and Puerto Rico.* JYNNEOS vaccine is licensed by the Food and Drug Administration (FDA) as a 0.5-mL 2-dose series administered subcutaneously 28 days apart to prevent smallpox and monkeypox infections (2) and has been found to provide protection against monkeypox infection during the current outbreak (3). The U.S. Department of Health and Human Services (HHS) allocated 1.1 million vials of JYNNEOS vaccine from the Strategic National Stockpile, with doses allocated to jurisdictions based on case counts and estimated size of population at risk (4). However, initial vaccine supplies were severely constrained relative to vaccine demand during the expanding outbreak. Some jurisdictions with highest incidence responded by prioritizing first dose administration during May-July (5,6). The FDA emergency use authorization (EUA) of 0.1 mL dosing for intradermal administration of JYNNEOS for persons aged ≥18 years on August 9, 2022, substantially expanded available vaccine supply(†) (7). The U.S. vaccination strategy focuses primarily on persons with known or presumed exposures to monkeypox (8) or those at high risk for occupational exposure (9). Data on monkeypox vaccine doses administered and reported to CDC by U.S. jurisdictions were analyzed to assess vaccine administration and completion of the 2-dose series. A total of 931,155 doses of JYNNEOS vaccine were administered and reported to the CDC by 55 U.S. jurisdictions during May 22-October 10, 2022. Among persons who received ≥1 dose, 51.4% were non-Hispanic White (White), 22.5% were Hispanic or Latino (Hispanic), and 12.6% were non-Hispanic Black or African American (Black). The percentages of vaccine recipients who were Black (5.6%) and Hispanic (15.5%) during May 22-June 25 increased to 13.3% and 22.7%, respectively, during July 31-October 10. Among 496,888 persons who received a first dose and were eligible for a second dose during the study period, 57.6% received their second dose. Second dose receipt was highest among older adults, White persons, and those residing in the South U.S. Census Bureau Region. Tracking and addressing disparities in vaccination can reduce inequities, and equitable access to and acceptance of vaccine should be an essential factor in planning vaccination programs, events, and strategies. Receipt of both first and second doses is necessary for optimal protection against Monkeypox virus infection. |
Employer requirements and COVID-19 vaccination and attitudes among healthcare personnel in the U.S.: Findings from National Immunization Survey Adult COVID Module, August - September 2021.
Lee JT , Sean Hu S , Zhou T , Bonner KE , Kriss JL , Wilhelm E , Carter RJ , Holmes C , de Perio MA , Lu PJ , Nguyen KH , Brewer NT , Singleton JA . Vaccine 2022 40 (51) 7476-7482 INTRODUCTION: Employer vaccination requirements have been used to increase vaccination uptake among healthcare personnel (HCP). In summer 2021, HCP were the group most likely to have employer requirements for COVID-19 vaccinations as healthcare facilities led the implementation of such requirements. This study examined the association between employer requirements and HCP's COVID-19 vaccination status and attitudes about the vaccine. METHODS: Participants were a national representative sample of United States (US) adults who completed the National Immunization Survey Adult COVID Module (NIS-ACM) during August-September 2021. Respondents were asked about COVID-19 vaccination and intent, requirements for vaccination, place of work, attitudes surrounding vaccinations, and sociodemographic variables. This analysis focused on HCP respondents. We first calculated the weighted proportion reporting COVID-19 vaccination for HCP by sociodemographic variables. Then we computed unadjusted and adjusted prevalence ratios for vaccination coverage and key indicators on vaccine attitudes, comparing HCP based on individual self-report of vaccination requirements. RESULTS: Of 12,875 HCP respondents, 41.5% reported COVID-19 vaccination employer requirements. Among HCP with vaccination requirements, 90.5% had been vaccinated against COVID-19, as compared to 73.3% of HCP without vaccination requirements-a pattern consistent across sociodemographic groups. Notably, the greatest differences in uptake between HCP with and without employee requirements were seen in sociodemographic subgroups with the lowest vaccination uptake, e.g., HCP aged 18-29 years, HCP with high school or less education, HCP living below poverty, and uninsured HCP. In every sociodemographic subgroup examined, vaccine uptake was more equitable among HCP with vaccination requirements than in HCP without. Finally, HCP with vaccination requirements were also more likely to express confidence in the vaccine's safety (68.3% vs. 60.1%) and importance (89.6% vs 79.6%). CONCLUSION: In a large national US sample, employer requirements were associated with higher and more equitable HCP vaccination uptake across all sociodemographic groups examined. Our findings suggest that employer requirements can contribute to improving COVID-19 vaccination coverage, similar to patterns seen for other vaccines. |
Evaluation of community perceptions and prevention practices related to ebola virus as part of outbreak preparedness in Uganda, 2020
Musaazi J , Namageyo-Funa A , Carter VM , Carter RJ , Lamorde M , Apondi R , Bakyaita T , Boore AL , Brown VR , Homsy J , Kigozi J , Koyuncu A , Nabaggala MS , Nakate V , Nkurunziza E , Stowell DF , Walwema R , Olowo A , Jalloh MF . Glob Health Sci Pract 2022 10 (3) Introduction: During the 2018–2020 Ebola virus disease (EVD) outbreak in the Democratic Republic of the Congo, risk communication and community engagement (RCCE) were prioritized in geographic areas in Uganda considered at high risk of introduction of EVD. To inform EVD preparedness in Uganda, we evaluated community perceptions and prevention practices related to EVD in 6 districts in Uganda. Methods: In March 2020, we conducted a population-based survey in 6 purposively selected districts in Uganda using multistage cluster sampling. We examined differences between districts classified as high- versus low risk for EVD in terms of their message exposure from RCCE; risk perception; and EVD knowledge, attitudes, and prevention practices. Results: A total of 3,485 respondents were interviewed (91% response rate). EVD message exposure was more common in the high- versus low-risk districts. EVD risk perceptions were low overall but greater in the high- versus low-risk districts. Comprehensive knowledge was significantly greater in the high- versus low-risk districts (adjusted prevalence ratio [aPR] 1.61, 95% confidence interval [CI]=1.35, 1.93). Respondents’ engagement in all 3 EVD prevention practices (frequent handwashing with soap, avoiding physical contact with suspected Ebola patients, and avoiding burials involving contact with a corpse) was very low (4%). However, respondents with comprehensive knowledge were more likely to engage in all 3 EVD prevention practices compared to respondents without comprehensive knowledge (aPR 1.87, 95% CI=1.08, 3.25). Conclusion: Our findings suggest that while RCCE efforts as part of EVD outbreak preparedness may have contributed to higher EVD knowledge in the targeted high-risk districts, uptake of prevention behaviors was similarly low across districts. In a non-outbreak setting, implementing targeted RCCE strategies may not be sufficient to motivate people to adopt protective behaviors in the absence of a high threshold of perceived threat such as in an active outbreak. © Musaazi et al. |
Temperature and oxygen saturation in skilled nursing facility residents positive for SARS-CoV-2 prior to symptom onset.
Lehnertz NB , Lifson A , Galloway E , Taylor J , Carter RJ , Kazazian L , Day K , Miller S , Mendez E , Lynfield R . J Am Geriatr Soc 2021 70 (2) 363-369 BACKGROUND: Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) spreads rapidly amongst residents of skilled nursing facilities (SNFs). The rapid transmission dynamics and high morbidity and mortality that occur in SNFs emphasize the need for early detection of cases. We hypothesized that residents of SNFs infected with SARS-CoV-2 would demonstrate an acute change in either temperature or oxygen saturation (SpO2) prior to symptom onset. The Minnesota Department of Health (MDH) conducted a retrospective analysis of both temperature and SpO2 at two separate SNFs to assess the utility of these quantitative markers to identify SARS-CoV-2 infection prior to the development of symptoms. METHODS: A retrospective analysis was conducted of 165 individuals positive for SARS-CoV-2 that were residents in in SNFs that experienced COVID-19 outbreaks during April-June 2020 in a metropolitan area of Minnesota. Age, sex, symptomology, temperature and SpO2 values, date of symptom onset and date of positive SARS-CoV-2 test were analyzed. Temperature and SpO2 values for the period 14 days before and after date of initial positive test were included. Descriptive analyses evaluated changes in temperature and SpO2, defined as either exceeding a set threshold or demonstrating an acute change between consecutive measurements. RESULTS: Two (1%) residents had a temperature value ≥100(o) F, and 30 (18%) had at least one value ≥99(o) F within 14 days before symptom development. One hundred and sixteen residents (70%) had at least one SpO2 value ≤94% while 131 (80%) had an acute decrease in SpO2 of ≥3% between consecutive values in the 14 days prior to symptom onset. CONCLUSIONS: Our results suggest that acute change in SpO2 might be useful in identification of SARS-CoV-2 infection prior to the development of symptoms among residents living in SNFs. Facilities may consider adding SpO2 to daily temperature and symptom screening checklists to improve early detection of residents of SNFs infected with SARS-CoV-2. |
Widespread SARS-CoV-2 Transmission Among Attendees at a Large Motorcycle Rally and their Contacts, 30 US Jurisdictions, August-September, 2020.
Carter RJ , Rose D , Sabo R , Clayton J , Steinberg J , Anderson M . Clin Infect Dis 2021 73 S106-S109 The 2020 Sturgis Motorcycle rally resulted in widespread transmission of SARS-CoV-2 across the United States. At least 649 COVID-19 cases were identified, including secondary and tertiary spread to close contacts. To limit transmission, persons attending events should wear masks and practice physical distancing. Persons with a known exposure should quarantine and obtain COVID-19 testing. |
Vaccination of contacts of Ebola virus disease survivors to prevent further transmission.
Doshi RH , Fleming M , Mukoka AK , Carter RJ , Hyde TB , Choi M , Nzaji MK , Bateyi SH , Christie A , Nichol ST , Damon IK , Beach M , Musenga EM , Fitter DL . Lancet Glob Health 2020 8 (12) e1455-e1456 On April 10, 2020, just 2 days before the anticipated declaration of the end of the North Kivu and Ituri Ebola virus disease (EVD) outbreak in DR Congo, and 53 days after the last confirmed case of EVD had been reported, a new case was confirmed. Sequencing of patient samples from the case in April and six others that followed indicated that these cases were likely to have come from a reintroduction of the virus from a persistently infected survivor.1 This group of cases marked the second flare-up linked to an EVD survivor during this outbreak. In November, 2019, a relapse case in North Kivu resulted in widespread transmission across multiple health zones, helping to extend the outbreak by at least 3 months. |
Serial Testing for SARS-CoV-2 and Virus Whole Genome Sequencing Inform Infection Risk at Two Skilled Nursing Facilities with COVID-19 Outbreaks - Minnesota, April-June 2020.
Taylor J , Carter RJ , Lehnertz N , Kazazian L , Sullivan M , Wang X , Garfin J , Diekman S , Plumb M , Bennet ME , Hale T , Vallabhaneni S , Namugenyi S , Carpenter D , Turner-Harper D , Booth M , Coursey EJ , Martin K , McMahon M , Beaudoin A , Lifson A , Holzbauer S , Reddy SC , Jernigan JA , Lynfield R . MMWR Morb Mortal Wkly Rep 2020 69 (37) 1288-1295 SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), can spread rapidly in high-risk congregate settings such as skilled nursing facilities (SNFs) (1). In Minnesota, SNF-associated cases accounted for 3,950 (8%) of 48,711 COVID-19 cases reported through July 21, 2020; 35% of SNF-associated cases involved health care personnel (HCP*), including six deaths. Facility-wide, serial testing in SNFs has been used to identify residents with asymptomatic and presymptomatic SARS-CoV-2 infection to inform mitigation efforts, including cohorting of residents with positive test results and exclusion of infected HCP from the workplace (2,3). During April-June 2020, the Minnesota Department of Health (MDH), with CDC assistance, conducted weekly serial testing at two SNFs experiencing COVID-19 outbreaks. Among 259 tested residents, and 341 tested HCP, 64% and 33%, respectively, had positive reverse transcription-polymerase chain reaction (RT-PCR) SARS-CoV-2 test results. Continued SARS-CoV-2 transmission was potentially facilitated by lapses in infection prevention and control (IPC) practices, up to 12-day delays in receiving HCP test results (53%) at one facility, and incomplete HCP participation (71%). Genetic sequencing demonstrated that SARS-CoV-2 viral genomes from HCP and resident specimens were clustered by facility, suggesting facility-based transmission. Residents and HCP working in SNFs are at risk for infection with SARS-CoV-2. As part of comprehensive COVID-19 preparation and response, including early identification of cases, SNFs should conduct serial testing of residents and HCP, maximize HCP testing participation, ensure availability of personal protective equipment (PPE), and enhance IPC practices(†) (4-5). |
Ebola vaccine Family first! Evidence from using a brief measure on Ebola vaccine demand in a national household survey during the outbreak in Sierra Leone
Jalloh MF , Wallace AS , Bunnell RE , Carter RJ , Redd JT , Nur SA , Zeebari Z , Ekstrom AM , Nordenstedt H . Vaccine 2020 38 (22) 3854-3861 BACKGROUND: Vaccination against Ebolavirus is an emerging public health tool during Ebola Virus Disease outbreaks. We examined demand issues related to deployment of Ebolavirus vaccine during the 2014-2015 outbreak in Sierra Leone. METHODS: A cluster survey was administered to a population-based sample in December 2014 (N = 3540), before any Ebola vaccine was available to the general public in Sierra Leone. Ebola vaccine demand was captured in this survey by three Likert-scale items that were used to develop a composite score and dichotomized into a binary outcome to define high demand. A multilevel logistic regression model was fitted to assess the associations between perceptions of who should be first to receive an Ebola vaccine and the expression of high demand for an Ebola vaccine. RESULTS: The largest proportion of respondents reported that health workers (35.1%) or their own families (29.5%) should receive the vaccine first if it became available, rather than politicians (13.8%), vaccination teams (9.8%), or people in high risk areas (8.2%). High demand for an Ebola vaccine was expressed by 74.2% of respondents nationally. The odds of expressing high demand were 13 times greater among those who said they or their families should be the first to take the vaccine compared to those who said politicians should be the first recipients (adjusted odds ratio [aOR] 13.0 [95% confidence interval [CI] 7.8-21.6]). The ultra-brief measure of the Ebola vaccine demand demonstrated acceptable scale reliability (Cronbach's alpha = 0.79) and construct validity (single-factor loadings > 0.50). CONCLUSION: Perceptions of who should be the first to get the vaccine was associated with high demand for Ebola vaccine around the peak of the outbreak in Sierra Leone. Using an ultra-brief measure of Ebola vaccine demand is a feasible solution in outbreak settings and can help inform development of future rapid assessment tools. |
Pregnancy outcomes among women receiving rVSVDelta-ZEBOV-GP Ebola vaccine during the Sierra Leone Trial to introduce a vaccine against Ebola
Legardy-Williams JK , Carter RJ , Goldstein ST , Jarrett OD , Szefer E , Fombah AE , Tinker SC , Samai M , Mahon BE . Emerg Infect Dis 2020 26 (3) 541-548 Little information exists regarding Ebola vaccine rVSVDeltaG-ZEBOV-GP and pregnancy. The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) randomized participants without blinding to immediate or deferred (18-24 weeks postenrollment) vaccination. Pregnancy was an exclusion criterion, but 84 women were inadvertently vaccinated in early pregnancy or became pregnant <60 days after vaccination or enrollment. Among immediate vaccinated women, 45% (14/31) reported pregnancy loss, compared with 33% (11/33) of unvaccinated women with contemporaneous pregnancies (relative risk 1.35, 95% CI 0.73-2.52). Pregnancy loss was similar among women with higher risk for vaccine viremia (conception before or <14 days after vaccination) (44% [4/9]) and women with lower risk (conception >15 days after vaccination) (45% [10/22]). No congenital anomalies were detected among 44 live-born infants examined. These data highlight the need for Ebola vaccination decisions to balance the possible risk for an adverse pregnancy outcome with the risk for Ebola exposure. |
Uganda's experience in Ebola virus disease outbreak preparedness, 2018-2019
Aceng JR , Ario AR , Muruta AN , Makumbi I , Nanyunja M , Komakech I , Bakainaga AN , Talisuna AO , Mwesigye C , Mpairwe AM , Tusiime JB , Lali WZ , Katushabe E , Ocom F , Kaggwa M , Bongomin B , Kasule H , Mwoga JN , Sensasi B , Mwebembezi E , Katureebe C , Sentumbwe O , Nalwadda R , Mbaka P , Fatunmbi BS , Nakiire L , Lamorde M , Walwema R , Kambugu A , Nanyondo J , Okware S , Ahabwe PB , Nabukenya I , Kayiwa J , Wetaka MM , Kyazze S , Kwesiga B , Kadobera D , Bulage L , Nanziri C , Monje F , Aliddeki DM , Ntono V , Gonahasa D , Nabatanzi S , Nsereko G , Nakinsige A , Mabumba E , Lubwama B , Sekamatte M , Kibuule M , Muwanguzi D , Amone J , Upenytho GD , Driwale A , Seru M , Sebisubi F , Akello H , Kabanda R , Mutengeki DK , Bakyaita T , Serwanjja VN , Okwi R , Okiria J , Ainebyoona E , Opar BT , Mimbe D , Kyabaggu D , Ayebazibwe C , Sentumbwe J , Mwanja M , Ndumu DB , Bwogi J , Balinandi S , Nyakarahuka L , Tumusiime A , Kyondo J , Mulei S , Lutwama J , Kaleebu P , Kagirita A , Nabadda S , Oumo P , Lukwago R , Kasozi J , Masylukov O , Kyobe HB , Berdaga V , Lwanga M , Opio JC , Matseketse D , Eyul J , Oteba MO , Bukirwa H , Bulya N , Masiira B , Kihembo C , Ohuabunwo C , Antara SN , Owembabazi W , Okot PB , Okwera J , Amoros I , Kajja V , Mukunda BS , Sorela I , Adams G , Shoemaker T , Klena JD , Taboy CH , Ward SE , Merrill RD , Carter RJ , Harris JR , Banage F , Nsibambi T , Ojwang J , Kasule JN , Stowell DF , Brown VR , Zhu BP , Homsy J , Nelson LJ , Tusiime PK , Olaro C , Mwebesa HG , Woldemariam YT . Global Health 2020 16 (1) 24 BACKGROUND: Since the declaration of the 10th Ebola Virus Disease (EVD) outbreak in DRC on 1st Aug 2018, several neighboring countries have been developing and implementing preparedness efforts to prevent EVD cross-border transmission to enable timely detection, investigation, and response in the event of a confirmed EVD outbreak in the country. We describe Uganda's experience in EVD preparedness. RESULTS: On 4 August 2018, the Uganda Ministry of Health (MoH) activated the Public Health Emergency Operations Centre (PHEOC) and the National Task Force (NTF) for public health emergencies to plan, guide, and coordinate EVD preparedness in the country. The NTF selected an Incident Management Team (IMT), constituting a National Rapid Response Team (NRRT) that supported activation of the District Task Forces (DTFs) and District Rapid Response Teams (DRRTs) that jointly assessed levels of preparedness in 30 designated high-risk districts representing category 1 (20 districts) and category 2 (10 districts). The MoH, with technical guidance from the World Health Organisation (WHO), led EVD preparedness activities and worked together with other ministries and partner organisations to enhance community-based surveillance systems, develop and disseminate risk communication messages, engage communities, reinforce EVD screening and infection prevention measures at Points of Entry (PoEs) and in high-risk health facilities, construct and equip EVD isolation and treatment units, and establish coordination and procurement mechanisms. CONCLUSION: As of 31 May 2019, there was no confirmed case of EVD as Uganda has continued to make significant and verifiable progress in EVD preparedness. There is a need to sustain these efforts, not only in EVD preparedness but also across the entire spectrum of a multi-hazard framework. These efforts strengthen country capacity and compel the country to avail resources for preparedness and management of incidents at the source while effectively cutting costs of using a "fire-fighting" approach during public health emergencies. |
Clinical surveillance and evaluation of suspected Ebola cases in a vaccine trial during an Ebola epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola
Conteh MA , Goldstein ST , Wurie HR , Gidudu J , Lisk DR , Carter RJ , Seward JF , Hampton LM , Wang D , Andersen LE , Arvay M , Schrag SJ , Dawson P , Fombah AE , Petrie CR , Feikin DR , Russell JBW , Lindblad R , Kargbo SAS , Samai M , Mahon BE . J Infect Dis 2018 217 S33-s39 Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. |
Implementing a multisite clinical trial in the midst of an Ebola outbreak: Lessons learned from the Sierra Leone Trial to Introduce a Vaccine against Ebola
Carter RJ , Idriss A , Widdowson MA , Samai M , Schrag SJ , Legardy-Williams JK , Estivariz CF , Callis A , Carr W , Webber W , Fischer ME , Hadler S , Sahr F , Thompson M , Greby SM , Edem-Hotah J , Momoh RM , McDonald W , Gee JM , Kallon AF , Spencer-Walters D , Bresee JS , Cohn A , Hersey S , Gibson L , Schuchat A , Seward JF . J Infect Dis 2018 217 S16-s23 The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE), a phase 2/3 trial of investigational rVSVG-ZEBOV-GP vaccine, was conducted during an unprecedented Ebola epidemic. More than 8600 eligible healthcare and frontline response workers were individually randomized to immediate (within 7 days) or deferred (within 18-24 weeks) vaccination and followed for 6 months after vaccination for serious adverse events and Ebola virus infection. Key challenges included limited infrastructure to support trial activities, unreliable electricity, and staff with limited clinical trial experience. Study staff made substantial infrastructure investments, including renovation of enrollment sites, laboratories, and government cold chain facilities, and imported equipment to store and transport vaccine at </=-60oC. STRIVE built capacity by providing didactic and practical research training to >350 staff, which was reinforced with daily review and feedback meetings. The operational challenges of safety follow-up were addressed by issuing mobile telephones to participants, making home visits, and establishing a nurse triage hotline. Before the Ebola outbreak, Sierra Leone had limited infrastructure and staff to conduct clinical trials. Without interfering with the outbreak response, STRIVE responded to an urgent need and helped build this capacity. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. |
Participant retention in a randomized clinical trial in an outbreak setting: Lessons from the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)
Carter RJ , Senesi RGB , Dawson P , Gassama I , Kargbo SAS , Petrie CR , Rogers MH , Samai M , Luman ET . J Infect Dis 2018 217 S65-s74 Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. |
The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An evaluation of rVSVG-ZEBOV-GP vaccine tolerability and safety during the West Africa Ebola outbreak
Samai M , Seward JF , Goldstein ST , Mahon BE , Lisk DR , Widdowson MA , Jalloh MI , Schrag SJ , Idriss A , Carter RJ , Dawson P , Kargbo SAS , Leigh B , Bawoh M , Legardy-Williams J , Deen G , Carr W , Callis A , Lindblad R , Russell JBW , Petrie CR , Fombah AE , Kargbo B , McDonald W , Jarrett OD , Walker RE , Gargiullo P , Bash-Taqi D , Gibson L , Fofanah AB , Schuchat A . J Infect Dis 2018 217 S6-s15 Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. |
Utilizing nurses to staff an Ebola vaccine clinical trial in Sierra Leone during the Ebola outbreak
Edem-Hotah J , McDonald W , Abu PM , Luman ET , Carter RJ , Koker A , Goldstein ST . J Infect Dis 2018 217 S60-s64 Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. |
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