Applicability of selected Brighton Collaboration case definitions in low-resource settings: A prospective hospital-based active surveillance in Addis Ababa, Ethiopia.

INTRODUCTION: Standardizing case definitions for priority vaccine safety conditions facilitates uniform evaluation and consolidation of data obtained from different settings. The Brighton Collaboration case definitions (BCCD) were created to support this harmonization and enable classification from level 1 (most certain) to level 5 (not a case) of certainty. Assessing the performance of BCCD in practice is critical, particularly in resource-limited settings, where many new vaccines may be introduced without prior monitoring in high-income countries. We assessed the performance of BCCD in Addis Ababa, Ethiopia, as applicable to COVID-19 and other vaccines. METHODS: Active surveillance was conducted at Tikur Anbessa Specialized Hospital, the largest referral hospital in Ethiopia. During June 1, 2022-May 31, 2023, three trained physicians prospectively identified patients eligible for COVID-19 vaccination (regardless of vaccine receipt) who presented with one or more of eleven pre-specified adverse events of special interest (AESI) from the emergency department and inpatient wards. Standardized data collection forms were used to capture patient information and assign level of certainty (LOC), regardless of vaccination status for COVID-19. We conducted descriptive analysis to characterize cases and the LOCs reached for each AESI. RESULTS: We detected 203 AESI cases. The most detected conditions were thrombosis and thromboembolism (n = 100, 49 %) and generalized convulsions (n = 38, 19 %). Ninety-six percent of the cases were confirmed at levels 1-3 (n = 187) or level 5 (n = 9) LOC. Non-classifiable (level 4) cases were observed for pericarditis (n = 2), encephalitis (n = 2), myelitis (n = 2), and generalized convulsion (n = 1). CONCLUSION: The BCCD were successfully applied in > 95 % of cases in a large referral hospital in Ethiopia, with generalized convulsion, pericarditis, and encephalomyelitis as the exceptions. We recommend further evaluation in other low-resource settings, particularly in rural or non-referral hospitals, to gain additional insights into performance of these definitions for revision or adaptation, as needed.

Demographic and travel characteristics and self-reported predeparture SARS-CoV-2 testing behavior in air passengers entering the United States from foreign destinations from July to September 2021.

INTRODUCTION: From January 2021 to June 2022, the United States Centers for Disease Control and Prevention required predeparture SARS-CoV-2 testing for all air passengers arriving into the United States from a foreign country. METHODS: Using data collected during a surveillance project, we described predeparture testing behavior among a convenience sample of international air passengers entering the United States from July to September 2021 at six US ports of entry. We analyzed pairwise relationships between self-reported test type, test timing, demographic and travel characteristics, and COVID-19 vaccination status using chi-square and Fisher's exact tests. RESULTS: Participants were more likely to get a NAAT versus antigen test if they identified as non-Hispanic Asian or Pacific Islander (68.2%, n = 173), non-Hispanic Black (62.6%, n = 147), or if they preferred not to report race and ethnicity (60.8%, n = 209) when compared to those who identified as non-Hispanic White (47.1%, n = 1086, all p < 0.05). Those who identified as Hispanic or Latino (n = 671) were less likely to get a NAAT than the non-Hispanic White group (39.5% vs. 47.1%, p < 0.05). Participants arriving in the US from the Americas were less likely to get a NAAT (38.5%, n = 871) compared to those arriving from Europe (45.5%, n = 1165, p < 0.05). Participants who reported receiving their predeparture test 2 days or 3 or more days before departure were more likely to report receiving a NAAT (52.2%, n = 879, and 60.2%, n = 410, respectively) than those who reported testing within 1 day (41.4%, n = 1040, all p < 0.001) of departure. DISCUSSION: Test type was significantly associated with race and ethnicity, departure region, and test timing. Differences likely reflected regional disparities in the availability of tests at the time of the activity. Discrepancies in predeparture test timing and type worldwide may have consequences for the effectiveness and equity of travel requirements in future pandemics.

Evaluation of Container Clinics as an Urban Immunization Strategy: Findings from the First Year of Implementation in Ghana, 2017-2018.

BACKGROUND: In 2017, the Expanded Programme on Immunization in Ghana opened two container clinics in Accra, which were cargo containers outfitted to deliver immunizations. At each clinic, we assessed performance and clinic acceptance during the first 12 months of implementation. METHODS: We employed a descriptive mixed-method design using monthly administrative immunization data, exit interviews with caregivers of children of <5 years (N = 107), focus group discussions (FGDs) with caregivers (n = 6 FGDs) and nurses (n = 2 FGDs), and in-depth interviews (IDIs) with community leaders (n = 3) and health authorities (n = 3). RESULTS: Monthly administrative data showed that administered vaccine doses increased from 94 during the opening month to 376 in the 12th month across both clinics. Each clinic exceeded its target doses for the 12-23 month population (second dose of measles). Almost all (98%) exit interview participants stated that the clinics made it easier to receive child health services compared to previous health service interactions. The accessibility and acceptability of the container clinics were also supported from health worker and community perspectives. CONCLUSIONS: Our initial data support container clinics as an acceptable strategy for delivering immunization services in urban populations, at least in the short term. They can be rapidly deployed and designed to serve working mothers in strategic areas.

COVID-19 cases reported in Colorado following screening at selected US airports, January - July 2020.

OBJECTIVE: We sought to estimate the proportion of air travelers who may have been infected with SARS-CoV-2 upon arrival to Colorado by comparing data on Colorado residents screened upon entering the US to COVID-19 cases reported in the state. Data on Colorado's screened passengers arriving into the US between January 17 and July 30, 2020 were compared to Colorado's Electronic Disease Reporting System. We conducted a descriptive analysis of true matches, including age, gender, case status, symptom status, time from arrival to symptom onset (days), and time from arrival to specimen collection date (days). RESULTS: Fourteen confirmed COVID-19 cases in travelers who were diagnosed within 14 days after arriving in Colorado were matched to the 8,272 travelers who underwent screening at 15 designated airports with a recorded destination of Colorado, or 0.2%. Most (N = 13/14 or 93%) of these infected travelers arrived in Colorado in March 2020; 12 (86%) of them were symptomatic. Entry screening for COVID-19 and the sharing of traveler information with the Colorado Department of Public Health and Environment appeared to identify few cases early in the pandemic. Symptom-based entry screening and sharing of traveler information was minimally effective at decreasing travel-associated COVID-19 transmission.

Optimising reporting of adverse events following immunisation by healthcare workers in Ghana: A qualitative study in four regions.

INTRODUCTION: Despite the emphasis on reporting of Adverse Events Following Immunisation (AEFIs) during didactic training sessions, especially prior to new vaccine introductions, it remains low in Ghana. We explored the factors underlying the under-reporting of AEFI by healthcare workers (HCWs) to provide guidance on appropriate interventions to increase reporting. METHODS: We conducted an exploratory descriptive in-depth study of the factors contributing to low reporting of AEFI among HCWs in four regions in Ghana. Key informant interviews (KII) were held with purposively selected individuals that are relevant to the AEFI reporting process at the district, regional, and national levels. We used KII guides to conduct in-depth interviews and used NVivo 10 qualitative software to analyse the data. Themes on factors influencing AEFI reporting were derived inductively from the data, and illustrative quotes from respondents were used to support the narratives. RESULTS: We conducted 116 KIIs with the health managers, regulators and frontline HCWs and found that lack of information on reportable AEFIs and reporting structures, misunderstanding of reportable AEFIs, heavy workload, cost of reporting AEFIs, fear of blame by supervisors, lack of motivation, and inadequate feedback as factors responsible for underreporting of AEFIs. Respondents suggested that capacity building for frontline HCWs, effective supervision, the provision of motivation and feedback, simplification of reporting procedures, incentives for integrating AEFI reporting into routine monitoring and reporting, standardization of reporting procedures across regions, and developing appropriate interventions to address the fear of personal consequences would help improve AEFI reporting. CONCLUSION: From the perspectives of a broad range of key informants at all levels of the vaccine safety system, we found multiple factors (both structural and behavioural), that may impact HCW reporting of AEFI in Ghana. Improvements in line with the suggestions are necessary for increased AEFI reporting in Ghana.

Enhanced surveillance for adverse events following immunization during the 2019 typhoid conjugate vaccine campaign in Harare, Zimbabwe.

BACKGROUND: During February 25-March 4, 2019, Zimbabwe's Ministry of Health and Child Care conducted an emergency campaign using 342,000 doses of typhoid conjugate vaccine (TCV) targeting individuals 6 months-15 years of age in eight high-risk suburbs of Harare and up to 45 years of age in one suburb of Harare. The campaign represented the first use of TCV in Africa outside of clinical trials. METHODS: Three methods were used to capture adverse events during the campaign and for 42 days following the last dose administered: (1) active surveillance in two Harare hospitals, (2) national passive surveillance, and (3) a post-campaign coverage survey. RESULTS: Thirty-nine adverse events were identified during active surveillance, including 19 seizure cases (16 were febrile), 16 hypersensitivity cases, 1 thrombocytopenia case, 1 anaphylaxis case, and two cases with two conditions. Only 21 (54%) of 39 patients were hospitalized and 38 recovered without sequelae. Attack rates per 100,000 TCV doses administered were highest for seizures (6.27) and hypersensitivity (5.02). Only 6 adverse events were reported through passive surveillance by facilities other than the two active surveillance hospitals. A total of 177 (10%) of 1,817 vaccinees surveyed reported experiencing an adverse event during the post-campaign coverage survey, of which 25 (14%) sought care. CONCLUSIONS: In line with previous evaluations of TCV, enhanced adverse event monitoring during an emergency campaign supports the safety of TCV. The majority of reported events were minor or resulted in recovery without long-term sequelae. Attack rates for seizures and hypersensitivity were low compared with previous active surveillance studies conducted in Kenya and Burkina Faso. Strengthening adverse event monitoring in Zimbabwe and establishing background rates of conditions of interest in the general population may improve future safety monitoring during new vaccine introductions.

Cross-sectional survey of SARS-CoV-2 testing at US airports and one health department's proactive management of travelers.

BACKGROUND: Many health departments and private enterprises began offering SARS-CoV-2 testing to travelers at US airports in 2020. Persons with positive SARS-CoV-2 test results who have planned upcoming travel may be subject to US federal public health travel restrictions. We assessed availability of testing for SARS-CoV-2 at major US airports. We then describe the management of cases and close contacts at Denver International Airport's testing site. METHODS: We selected 100 US airports. Online surveys were conducted during November-December 2020 and assessed availability of testing for air travelers, flight crew, and airport employees. Respondents included health department (HD) staff or airport directors. We analyzed testing data and management practices for persons who tested positive and their close contacts at one airport (Denver International) from 12/21/2020 to 3/31/2021. RESULTS: Among the 100 selected airports, we received information on 77 airports; 38 (49%) had a testing site and several more planned to offer one (N = 7; 9%). Most sites began testing in the fall of 2020. The most frequently offered tests were RT-PCR or other NAAT tests (N = 28). Denver International Airport offered voluntary SARS-CoV-2 testing. Fifty-four people had positive results among 5724 tests conducted from 12/21/2020 to 3/31/2021 for a total positivity of < 1%. Of these, 15 were travelers with imminent flights. The Denver HD issued an order requiring the testing site to immediately report cases and notify airlines to cancel upcoming flight itineraries for infected travelers and their traveling close contacts, minimizing the use of federal travel restrictions. CONCLUSIONS: As of December 2020, nearly half of surveyed US airports had SARS-CoV-2 testing sites. Such large-scale adoption of airport testing for a communicable disease is unprecedented and presents new challenges for travelers, airlines, airports, and public health authorities. This assessment was completed before the US and other countries began enforcing entry testing requirements; testing at airports will likely increase as travel demand returns and test requirements for travel evolve. Lessons from Denver demonstrate how HDs can play a key role in engaging airport testing sites to ensure people who test positive for SARS-CoV-2 immediately before travel do not travel on commercial aircraft.

An approach for preparing and responding to adverse events following immunization reported after hepatitis B vaccine birth dose administration.

The success of immunization programs in lowering the incidence of vaccine preventable diseases (VPDs) has led to increased public attention on potential health risks associated with vaccines. As a result, a scientifically rigorous response to investigating reported adverse events following immunization (AEFI) and effective risk communications strategies are critical to ensure public confidence in immunization. Globally, an estimated 257 million people have chronic hepatitis B virus (HBV) infection, which causes more than 686,000 premature deaths from liver cancer and cirrhosis. Hepatitis B vaccination is the most effective way to prevent mother-to-child transmission of HBV infection, especially when a timely birth dose is given within 24 h of birth. However, an infant's risk of dying is highest in the neonatal period, and thus, administering HepB-BD within 24 h of birth overlaps with the most fragile period in an infant's life. A working group formed in July 2016 following the publication of the case reports of the effects on vaccination coverage of media reports of infant deaths after HepB-BD administration in China and Vietnam. The goal of the working group was to create a framework and describe best practices for preparing for and responding to AEFI reported after HepB-BD administration, using existing resources. The framework includes six steps, including three preparation steps and three response steps. This document is written for national and regional immunization program staff. Prior to using the framework for preparation and response to AEFIs reported after HepB-BD administration, staff members should be familiar with how AEFI are detected, reported, and investigated in the country. The document might also be of interest to national regulatory staff members who monitor vaccine safety within the country.

Barriers to healthcare workers reporting adverse events following immunization in four regions of Ghana.

Despite didactic training on adverse events following immunization (AEFI) in Ghana, the reporting ratio of AEFI was 1.56 per 100,000 surviving infants in 2015, below the minimum reporting ratio of 10. We aimed to estimate the proportion of health care workers (HCWs) reporting AEFI and to identify barriers to reporting. We conducted a cross-sectional survey of HCWs in four regions in Ghana. A simple random sample of 176 health facilities was selected and up to two HCWs were randomly selected per facility. We used the Rao-Scott Chi-squared test to compare factors associated with reporting of AEFI in the last year. We used an open-ended question to identify reasons for low reporting. One supervisor from each facility, responsible for overall reporting and management of AEFI, was also interviewed. A total of 306 HCWs from 169 facilities were interviewed. Of these, 176 (57.5%) reported they had ever encountered an AEFI. Of the 120 who had encountered an AEFI in the last year, 66 (55.0%) indicated they had reported the AEFI, and 38 (31.7%) completed a reporting form. HCWs (n = 120) reported multiple barriers to reporting of AEFI; the most common barriers were fear of personal consequences (44.1%), lack of knowledge or training (25.2%), and not believing an AEFI was serious enough to report (22.2%). Discussion of AEFI during the last supervisory visit was significantly associated with reporting in the past year (OR 7.39; p < .001). Of 172 supervisors interviewed, 65 (37.8%) mentioned their facilties had ever encountered an AEFI; over 90% of facilities had reporting forms. We identified low reporting of AEFI and multiple barriers to reporting among HCWs in the four selected regions of Ghana. Discussing AEFI during supervisory visits with HCWs might improve reporting. Additionally, strategies to address fear of personal consequences as a barrier to reporting of AEFI are needed.