Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports.

OBJECTIVE: Describe available data on birth defects and pregnancy loss in women with systemic lupus erythematosus (SLE) exposed to belimumab. METHODS: Data collected from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports up to 8 March 2020 were described. Belimumab exposure timing, concomitant medications and potential confounding factors were summarised descriptively. RESULTS: Among 319 pregnancies with known outcomes (excluding elective terminations), 223 ended in live births from which birth defects were identified in 4/72 (5.6%) in belimumab-exposed pregnancies and 0/9 placebo-exposed pregnancies across 18 clinical trials, 10/46 (21.7%) belimumab-exposed pregnancies in the BPR prospective cohort (enrolled prior to pregnancy outcome) and 0/4 belimumab-exposed pregnancies in the BPR retrospective cohort (enrolled after pregnancy outcome), and 1/92 (1.1%) in belimumab-exposed pregnancies from postmarketing/spontaneous reports. There was no consistent pattern of birth defects across datasets. Out of pregnancies with known outcomes (excluding elective terminations), pregnancy loss occurred in 31.8% (35/110) of belimumab-exposed women and 43.8% (7/16) of placebo-exposed women in clinical trials; 4.2% (2/48) of women in the BPR prospective cohort and 50% (4/8) in the BPR retrospective cohort; and 31.4% (43/137) of belimumab-exposed women from postmarketing/spontaneous reports. All belimumab-exposed women in clinical trials and the BPR received concomitant medications and had confounding factors and/or missing data. CONCLUSIONS: Observations reported here add to limited data published on pregnancy outcomes following belimumab exposure. Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.

Association of water quality with soil-transmitted helminthiasis and diarrhea in Nueva Santa Rosa, Guatemala, 2010.

Improved water quality reduces diarrhea, but the impact of improved water quality on Ascaris and Trichuris, soil-transmitted helminths (STH) conveyed by the fecal-oral route, is less well described. To assess water quality associations with diarrhea and STH, we conducted a cross-sectional survey in households of south-eastern Guatemala. Diarrhea was self-reported in the past week and month. STH was diagnosed by stool testing using a fecal parasite concentrator method. We explored associations between Escherichia coli-positive source water (water quality) and disease outcomes using survey logistic regression models. Overall, 732 persons lived in 167 households where water was tested. Of these, 79.4% (581/732) had E. coli-positive water, 7.9% (58/732) had diarrhea within the week, 14.1% (103/732) had diarrhea within the month, and 6.6% (36/545) tested positive for Ascaris or Trichuris, including 1% (6/536) who also reported diarrhea. Univariable analysis found a statistically significant association between water quality and STH (odds ratio [OR] = 5.1, 95% confidence interval [CI] = 1.1-24.5) but no association between water quality and diarrhea. Waterborne transmission and effects of water treatment on STH prevalence should be investigated further. If a causal relationship is found, practices such as household water treatment including filtration might be useful adjuncts to sanitation, hygiene, and deworming in STH control programs.

Genetic Evidence of Importation of Drug-Resistant Plasmodium falciparum to Guatemala from the Democratic Republic of the Congo.

Imported malaria threatens control and elimination efforts in countries that have low rates of transmission. In 2010, an outbreak of Plasmodium falciparum malaria was reported among United Nations peacekeeping soldiers from Guatemala who had recently returned from the Democratic Republic of the Congo (DRC). Epidemiologic evidence suggested that the soldiers were infected in the DRC, but local transmission could not be ruled out in all cases. We used population genetic analyses of neutral microsatellites to determine the outbreak source. Genetic relatedness was compared among parasites found in samples from the soldiers and parasite populations collected in the DRC and Guatemala; parasites identified in the soldiers were more closely related to those from the DRC. A phylogenetic clustering analysis confirms this identification with >99.9% confidence. Thus, results support the hypothesis that the soldiers likely imported malaria from the DRC. This study demonstrates the utility of molecular genotyping in outbreak investigations.

Hospital Healthcare Resource Utilization and Associated Hospital Costs of Patients With Lupus Nephritis in China: A National Administrative Claim Database Study.

OBJECTIVES: Assess hospital healthcare resource utilization (HCRU) and associated hospital costs of patients with lupus nephritis (LN) in China and compare these outcomes with a systemic lupus erythematosus (SLE) cohort (SLE with/without LN) as well as exploring the effect of end-stage kidney disease (ESKD). METHODS: This retrospective administrative claims-based analysis identified patients with SLE and SLE with LN from China using diagnosis codes and keywords. Patients with LN were subcategorized by presence of ESKD. Outcomes included all-cause and disease-specific HCRU (defined as healthcare visits including inpatient and outpatient visits) and medical costs (in 2022 US dollars). RESULTS: In total, 3645 patients with SLE were included, of whom 404 (11%) had LN. Among those with LN, 142 (35%) had ESKD. Median (interquartile range) all-cause healthcare visits per patient per month (PPPM) was significantly greater for patients with LN (2.08 [4.01]) vs SLE (0.92 [1.64]; P < .0001). Patients with LN and ESKD (3.00 [4.18]) had numerically more all-cause healthcare visits PPPM compared with LN patients without ESKD (1.50 [3.45]). Median all-cause costs PPPM were significantly greater among patients with LN ($287.46 [477.15]) vs SLE ($113.09 [267.39]; P < .0001) and numerically higher for patients with LN and ESKD ($466.29 [958.90]) vs LN without ESKD ($223.50 [319.56]). CONCLUSIONS: Chinese patients with LN had greater HCRU and hospital healthcare costs compared with the general SLE cohort. This burden was higher for those with ESKD. These data highlight the substantial HCRU among patients with LN in China, especially those with ESKD, suggesting the need for early diagnosis and timely management of LN to mitigate the economic burden.

National outbreak of type a foodborne botulism associated with a widely distributed commercially canned hot dog chili sauce.

BACKGROUND: On 7 and 11 July 2007, health officials in Texas and Indiana, respectively, reported 4 possible cases of type A foodborne botulism to the US Centers for Disease Control and Prevention. Foodborne botulism is a rare and sometimes fatal illness caused by consuming foods containing botulinum neurotoxin. METHODS: Investigators reviewed patients' medical charts and food histories. Clinical specimens and food samples were tested for botulinum toxin and neurotoxin-producing Clostridium species. Investigators conducted inspections of the cannery that produced the implicated product. RESULTS: Eight confirmed outbreak associated cases were identified from Indiana (n = 2), Texas (n = 3), and Ohio (n = 3). Botulinum toxin type A was identified in leftover chili sauce consumed by the Indiana patients and 1 of the Ohio patients. Cannery inspectors found violations of federal canned-food regulations that could have led to survival of Clostridium botulinum spores during sterilization. The company recalled 39 million cans of chili. Following the outbreak, the US Food and Drug Administration inspected other canneries with similar canning systems and issued warnings to the industry about the danger of C. botulinum and the importance of compliance with canned food manufacturing regulations. CONCLUSIONS: Commercially produced hot dog chili sauce caused these cases of type A botulism. This is the first US foodborne botulism outbreak involving a commercial cannery in >30 years. Sharing of epidemiologic and laboratory findings allowed for the rapid identification of implicated food items and swift removal of potentially deadly products from the market by US food regulatory authorities.

Importation of chloroquine-resistant Plasmodium falciparum by Guatemalan peacekeepers returning from the Democratic Republic of the Congo.

BACKGROUND: Malaria elimination is being pursued in five of seven Central American countries. Military personnel returning from peacekeeping missions in sub-Saharan Africa could import chloroquine-resistant Plasmodium falciparum, posing a threat to elimination and to the continued efficacy of first-line chloroquine (CQ) treatment in these countries. This report describes the importation of P. falciparum from among 150 Guatemalan army special forces and support staff who spent ten months on a United Nations' peacekeeping mission in the Democratic Republic of the Congo (DRC) in 2010. METHODS: Investigators reviewed patients' medical charts and interviewed members of the contingent to identify malaria cases and risk factors for malaria acquisition. Clinical specimens were tested for malaria; isolated parasites were characterized molecularly for CQ resistance. RESULTS: Investigators identified 12 cases (8%) of laboratory-confirmed P. falciparum infection within the contingent; one case was from a soldier infected with a CQ-resistant pfcrt genotype resulting in his death. None of the contingent used an insecticide-treated bed net (ITN) or completely adhered to malaria chemoprophylaxis while in the DRC. CONCLUSION: This report highlights the need to promote use of malaria prevention measures, in particular ITNs and chemoprophylaxis, among peacekeepers stationed in malaria-endemic areas. Countries attempting to eliminate malaria should consider appropriate methods to screen peacekeepers returning from endemic areas for malaria infections. Cases of malaria in travellers, immigrants and soldiers returning to Central America from countries with CQ-resistant malaria should be assumed to be carry resistant parasites and receive appropriate anti-malarial therapy to prevent severe disease and death.

Healthcare Costs and Utilization for Patients With Systemic Lupus Erythematosus in China: A National Claims Database Study.

OBJECTIVES: This study aimed to describe the healthcare resource utilization (HCRU) and healthcare costs associated with systemic lupus erythematosus (SLE) management in China from the patient's and the payer's perspective. METHODS: HCRU and medical costs (2017 US dollar [USD]) between January 1 and December 31, 2017, were extracted from the national medical insurance claims database, China Health Insurance Research Association (consisting of claims from all public health insurance schemes in China), for adults with ≥ 1 SLE-related claim. The main analysis group comprised all adults with an SLE diagnosis and claim during 2017 (overall group); the annual subgroup (SLE diagnosis and claim in January 2017) informed annual HCRU and costs. RESULTS: The overall group consisted of 3645 adults with ≥ 1 SLE-related claim. Outpatient visits constituted 86.9% of healthcare visits. SLE-related healthcare outpatient costs were USD 433 per outpatient, and inpatient costs were USD 2072 per inpatient. Medication costs accounted for 75.0% (USD 42/56) of total costs for outpatient visits and 44.3% (USD 456/1030) for inpatient hospitalizations. Notably, 35.4% of patients had a severe SLE flare; mean SLE-related cost per severe flare was USD 1616. HCRU and costs were similar in the annual subgroup. Female sex, SLE flares, tertiary hospitals, renal involvement, and utilization of anti-infective drugs were associated with higher SLE-related patient costs. CONCLUSIONS: SLE in China is associated with considerable HCRU and medical costs, especially for patients experiencing severe SLE flares. Preventing organ involvement, infections, flares, and associated hospitalizations may reduce the burden on patients and healthcare providers in China.

Knowledge, Attitudes, and Practices Concerning Maternal Immunization Among Pregnant/Postpartum Women and Health Care Professionals in Peru.

INTRODUCTION: For pregnant women, vaccination with inactivated influenza vaccine (IIV) and tetanus, diphtheria, acellular pertussis vaccine (Tdap) is recommended. In Peru, uptake is nonetheless low. A study was conducted to identify factors affecting maternal vaccination coverage. The study's primary objectives were to describe the knowledge, attitudes, and practices regarding maternal immunization among pregnant/postpartum women and health care professionals (HCPs). The secondary objective was to determine the vaccination coverage and the impact of Ministry of Health (MOH) recommendations. METHODS: An observational multicenter, cross-sectional survey study was conducted from February 1, 2021 to June 30, 2021 in five cities in Peru. Two surveys were conducted to assess knowledge, attitudes, and practices concerning maternal immunization: one among pregnant/postpartum women and one among HCPs. RESULTS: Participants were 668 pregnant/postpartum women with a mean age of 29.6 years and 219 HCPs-mostly midwives (46.6%) and obstetricians/gynecologists (44.7%). Of the pregnant/postpartum women, 66.9% knew that, in general, vaccinations are given for prevention, and 98.5% believed vaccines are important. Nonetheless, 69.6% of pregnant/postpartum women had poor or moderate knowledge of maternal vaccination. Disease knowledge of influenza (89.1%) and tetanus (87.0%) was high, while knowledge of pertussis (37.7%) was low. Women agreed/strongly agreed that they would get vaccinated with Tdap if a doctor (96.3%), midwife (88.9%), or nurse (72.0%) recommended it. Of the HCPs, 81.3% routinely recommended Tdap vaccination for pregnant women. CONCLUSIONS: To enhance vaccine acceptance in pregnant women in Peru, we must improve knowledge of the diseases, MOH recommendations, and benefits of the offered vaccinations. HCPs could provide this vaccination knowledge and information along with their vaccination recommendation as the pregnant/postpartum women indicated they would take the vaccines if recommended by their HCPs. Our findings are important for the successful implementation of maternal immunization programs in Peru.

Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry.

BACKGROUND: Belimumab is approved for active, autoantibody-positive systemic lupus erythematosus (SLE) and lupus nephritis, but limited data exist regarding its use in pregnancy. The Belimumab Pregnancy Registry (BPR, GSK Study BEL114256; NCT01532310) was created to evaluate pregnancy and infant outcomes following belimumab exposure. METHODS: Individuals with SLE exposed to belimumab from 4 months before and/or during pregnancy can enroll into the BPR. The primary outcome is major birth defects; secondary outcomes include miscarriages, stillbirths, elective termination, pre-term birth, neonatal death, small for gestational age, and adverse infant outcomes during the first year of life. Belimumab exposure timing, concomitant medications, and other potential confounding factors are also collected. Data up to March 8, 2021, are reported descriptively. RESULTS: From an expected sample size target of 500 prospective pregnancies with a known outcome, only 55 were enrolled in the study. Among these, two pregnancy losses and 53 pregnancies with a live birth outcome were reported. Ten of the 53 live birth pregnancies resulted in a major birth defect. Ten pregnancies were enrolled after the pregnancy outcome occurred and were examined retrospectively (four live births with no defects, four miscarriages, and two elective terminations). There was no indication or pattern of birth defects associated with belimumab. CONCLUSIONS: Low recruitment numbers for the BPR and incomplete information limit the conclusions regarding belimumab exposure during pregnancy. There was no pattern or common mechanism of birth defects associated with belimumab within the BPR data.

Renal response at 2 years post biopsy to predict long-term renal survival in lupus nephritis: a retrospective analysis of the Hopkins Lupus Cohort.

OBJECTIVE: This retrospective analysis evaluated the prognostic value of renal response status 2 years after biopsy-proven lupus nephritis (LN) for the prediction of long-term renal outcomes. METHODS: Eligible patients with SLE as per American College of Rheumatology or Systemic Lupus International Collaborating Clinics criteria and biopsy-proven class III, IV, V or mixed LN were identified from the Hopkins Lupus Cohort, and categorised into binary renal response categories (modified primary efficacy renal response (mPERR) or no mPERR at 2 years post biopsy). These categories were defined by a modified version of the Belimumab International Lupus Nephritis Study (BLISS-LN) protocol using urine protein:creatinine ratio (≤0.7 g/day) and estimated glomerular filtration rate (≥60 mL/min/1.73 m2 or ≤20% below the baseline value) criteria. Long-term renal survival (defined as survival without end-stage renal disease (ESRD) or death) and chronic renal insufficiency-free survival were assessed in Kaplan-Meier plots with log-rank test and covariate-adjusted Cox proportional hazards models. RESULTS: Of the 173 eligible patients, 91.3% were female; the mean (SD) age at biopsy was 36.2 (11.8) years. At 2 years post biopsy, 114 (65.9%) patients achieved mPERR. These patients showed a lower risk of ESRD/death and chronic renal insufficiency in the follow-up period (HR (95% CI) 0.33 (0.13 to 0.87), p=0.0255; and HR (95% CI) 0.26 (0.14 to 0.47), p<0.0001, respectively). CONCLUSIONS: The 2-year post-biopsy renal response status, defined per 2019-updated BLISS-LN criteria, has prognostic value for long-term renal survival and lower risk of chronic renal insufficiency in patients with LN.

Incidence and Mortality Trends of Acute Gastroenteritis and Pneumococcal Disease in Children Following Universal Rotavirus and Pneumococcal Conjugate Vaccination in Ecuador.

INTRODUCTION: Ecuador introduced routine infant rotavirus (RV) vaccination in 2008 and pneumococcal conjugate vaccination (PCV) in 2011 to manage disease and mortality in children caused by gastroenteritis (GE) and by pneumonia (PNE) and invasive pneumococcal disease (IPD), respectively. METHODS: This retrospective ecological database study described vaccination coverage as well as the trends in incidence and mortality in the pre- versus post-vaccination periods and used time-trend analysis models to assess the impact of vaccination. RESULTS: RV vaccination coverage of the second dose was between 79-97% from 2008 to 2016. GE incidence and mortality showed a declining trend before vaccination which continued in the post-vaccination period. The model estimated a statistically significant decrease of 72.4% for GE mortality and 51.2% for GE incidence in the post-vaccination period. PCV vaccination coverage remained above 80% (second dose) and 40% (third dose) after 2011. PNE mortality showed a declining trend before vaccination and a continued decline after vaccination, while PNE incidence was more variable (sharp increase from 2005-2009 then decrease and eventual stabilisation). The model estimated a statistically significant decline of 41.1% for PNE mortality and a stable PNE incidence in the post- versus pre-vaccination period. IPD incidence and mortality yearly data showed large variability by year and low numbers, making it difficult to discern a trend. The model estimated a statistically significant reduction of 51.1% for IPD mortality and 31.5% for IPD incidence in the post- versus pre-vaccination period. CONCLUSION: After the first 9 years of routine RV vaccination and 6 years of routine PCV vaccination in Ecuador, significant decreases in incidence and mortality in children < 5 years of age due to GE and pneumococcal disease have been observed.

Acute Gastroenteritis Morbidity and Mortality Trends Following Universal Rotavirus Vaccination in Children in Peru: Ecological Database Study with Time-Trend Analysis.

INTRODUCTION: Rotavirus (RV) infection is the leading cause of severe diarrhea in children worldwide. It is responsible for around 25% of gastroenteritis (GE) cases, 33% of hospitalized GE cases, and an annual mortality rate of 113.4/100,000 in children < 5 years of age in Peru. RV infant vaccination is recommended by the World Health Organization and provides the best public health strategy to manage the disease. Universal RV vaccination was introduced in Peru in 2009. METHODS: Trends in GE ambulatory visits, hospitalizations, and deaths in children < 5 years of age are described in the pre-vaccination (2004-2008) versus post-vaccination (2010-2018) periods. Time-trend analysis was performed (using generalized linear regression models) to assess the impact of vaccination nationwide and by region after adjusting for variables. RESULTS: Between 2009 and 2011, vaccination coverage increased to over 80% in Peru. In infants < 1 year of age, GE ambulatory cases, hospitalizations, and deaths decreased in the post-vaccination period by 40.3%, 46.2%, and 55.5%, respectively (and in children < 5 years of age, by 34.4%, 41.9%, and 54.3%, respectively) compared with the pre-vaccination period. Results of the multivariate time-trend analysis also found significant decreases in the post-vaccination period of 10.7% (GE ambulatory cases), 17.2% (GE hospitalizations), and 37.3% (GE mortality) in children < 5 years of age. Data analyzed by region varied, with Costa and Sierra regions generally in line with the national findings; however, some findings were less robust for Selva due to fewer available data. CONCLUSION: After 9 years of RV vaccination in Peru, there appears to be a statistically significant positive impact of vaccination, in terms of reducing GE-related mortality, hospitalizations, and ambulatory visits in infants and young children. For policymakers to understand regional differences and future vaccination needs, continued improvement in surveillance is needed.

Trends in all-cause pneumonia and otitis media in children aged <2 years following pneumococcal conjugate vaccine introduction in Colombia.

In Colombia, pneumococcal conjugate vaccines (PCVs) were implemented into the infant universal mass vaccination program in a stepwise manner; PCV-7 between 2009 and 2011 in different geographic regions/cities, with nationwide introduction of a 10-valent vaccine (PHiD-CV) in 2012. We aimed to describe trends in all-cause pneumonia mortality and overall mortality, and in the incidence of all-cause pneumonia and otitis media (OM) in Colombian children <2 y (y = years) of age, before and after PCV introduction. We obtained mortality and incidence data, nationally and for five major cities (Bogota, Medellin, Barranquilla, Cali and Cartagena) from 2005-2016 and 2008-2016, respectively, comparing mortality and incidence proportions in the post-PCV introduction period with those in the pre-PCV period. Overall mean reductions in all-cause pneumonia mortality was observed in the post-PCV period nationally (48.8%; 95%CI: 45.5-51.8%) and in four cities including Bogota (77.1%; 71.1-81.8%) and Medellin (56.4%; 44.1-65.9%); no substantial reduction was observed in Cartagena. Similar findings were observed for overall mortality. Reductions in all-cause pneumonia incidence were observed in Bogota (66.0%; 65.5-66.6%), Medellin (40.6%; 39.3-41.9%) and Cartagena (15.0%; 11.2-18.6%), while incidence increased in Barranquilla (78.5%; 68.4-89.2%) and Cali (125.5%; 119.2-132.0%). All-cause OM incidence fell in Medellin and Bogota (42.1-51.1%) but increased (95.8%) in Barranquilla. In conclusion, overall reductions in disease outcomes were observed following PCV introduction in most cities and nationwide. Decreasing trends in outcomes were observed prior to PCV introduction, and limited data points and data reporting issues may have influenced our results. (ClinicalTrials.gov: NCT02567747).

Burden of Seasonal Influenza A and B in Panama from 2011 to 2017: An Observational Retrospective Database Study.

INTRODUCTION: Influenza A and B viruses constantly evolve and cause seasonal epidemics and sporadic outbreaks. Therefore, epidemiological surveillance is critical for monitoring their circulation pattern. Trivalent and quadrivalent vaccine formulations are available in Panama (until and since 2016, respectively). Herein, we analysed influenza A and B epidemiological patterns in Panama. METHODS: This was a retrospective descriptive analysis of all laboratory-confirmed influenza nasopharyngeal samples recorded between 2011 and 2017 in the nationwide surveillance database of Gorgas Memorial Institute for Health Studies. The analysis involved data relative to demographic information, virus type, subtype and lineage, geographic region, treatment and outcomes. The percentage level of mismatch between circulating and vaccine-recommended B lineage was assessed for each May-October influenza season. RESULTS: Among 1839 influenza cases, 79.6% were type A and 20.4% were type B. Most of them were observed in Panama City (54.7%) followed by the West (23.2%) and Central (16.7%) regions; across all regions, influenza A and B cases were distributed in a 4:1 ratio. Overall, approximately half were hospitalized (52.0% for type A; 45.5% for type B) and 11 (0.6%) died. Treatment, usually antimicrobial, was administered in 15.1% of cases. Children less than 2 years old were the most affected by this disease. Influenza type A circulated every year, while influenza B only circulated in 2012, 2014 and 2017. In the 2012 May-October influenza B season, the predominant lineage was B/Victoria and a switch to B/Yamagata was observed in 2014. Both lineages co-circulated in 2017, leading to a 38.9% B-lineage-level vaccine mismatch. CONCLUSION: Influenza A was predominant among all ages and children less than 2 years and inhabitants of Panama City reported the highest circulation rate. In 2017, co-circulation of both B lineages led to a vaccine mismatch. Continuous monitoring of seasonal influenza is critical to establish immunization recommendations.

Influenza or "flu" is caused by influenza viruses A and B and its symptoms range from mild to severe. This virus is constantly evolving; thus, careful monitoring of influenza is important to update immunization and vaccine recommendations yearly. This study used data from surveillance centres in Panama from 2011 to 2017 and evaluated the number of flu cases by age, gender, region, virus type, symptoms, comorbidities, treatment, coinfections with other viruses, and the circulating influenza subtype and the vaccine recommended each year. We found several points: almost 80% of cases were influenza A; most of the positive samples were found in children less than 2 years old and the Panama city region; more than 50% of influenza cases needed hospitalization; and in 2017 a mismatch was detected between the circulating influenza subtype and the recommended vaccine. This study helped to better characterize influenza circulation patterns and the burden of the disease during 2011­2017. We concluded that continuous monitoring of the influenza cases is necessary to establish future vaccination recommendations.

Pertussis infant morbidity and mortality trends after universal maternal immunisation in Mexico: An ecological database study with time-series analysis.

INTRODUCTION: Pertussis is a highly contagious infectious disease caused by Bordetella pertussis and a leading cause of infant mortality in Mexico. The Tetanus-diphtheria-acellular pertussis (Tdap) vaccine was recommended in the Mexican Immunisation Programme for pregnant women in 2013. We describe pertussis morbidity and mortality trends in infants ≤2 and ≤12 months of age), before and after maternal Tdap immunisation implementation in Mexico. METHODS: An ecological retrospective database study was performed in the Mexican National and Workers Social Security Institutes (IMSS; ISSSTE). Data were collected on confirmed pertussis ambulatory cases, hospitalisations, and deaths, plus vaccination coverage (Tdap; Diphtheria-tetanus-acellular pertussis [DTPa]) and population estimates. Descriptive and regression time-trend analyses were performed for pertussis morbidity and mortality in infants between pre- (2010-2012) and post- (2014-2018) maternal Tdap immunisation periods. RESULTS: Around 1 million infants a year are covered in IMSS/ISSSTE databases. Average full primary infant DTPa vaccine coverage was 71.4%-72.7% nationally. Since 2013, annual maternal Tdap vaccine coverage ranged from 70%-93%. Between 2010-2018, 2,024 pertussis cases, 2,518 hospitalisations and 71 deaths were reported in infants. Among infants 0-2 months old (maternal immunisation target group), there was a significant decrease, post-maternal vaccination, in pertussis incidence (49.9%, p < 0.000), hospitalisation (70.0%, p < 0.000) and mortality (82.4%, p = 0.003). In infants 0-12 months old, pertussis hospitalisations (28.9%, p = 0.000) and mortality (36.2%, p = 0.059) decreased, but incidence increased (61.8%, p = 0.000). CONCLUSION: After maternal immunisation was implemented, there was a decreasing trend in incidence, hospitalisation and death due to pertussis in infants 0-2 months old. Increases in incidence reported in 0-12-month-olds are likely due to major changes in diagnosis and reporting introduced during the study period as well as limited vaccination and health coverage in some states. These findings confirm the important contribution of the Tdap maternal immunisation programme in reducing pertussis disease burden, particularly severe disease, among infants in Mexico.

Hepatitis A antibody persistence 8 and 10 years after 1-dose and 2-dose vaccination in children from Panama.

BACKGROUND: Hepatitis A virus (HAV) remains a global public health concern, which is potentially growing in Latin America, due to an expected shift from high to intermediate endemicity levels. The use of HAV vaccines in pediatric national immunization programs (NIPs), either as a 2-dose or a 1-dose schedule, has been explored in Latin American countries; however, evidence demonstrating long-term protection in this population is limited in the region. We evaluated long-term antibody persistence following a 1-dose partial series and the recommended 2-dose schedule used in Panama's pediatric NIP. METHODS: Two independent cross-sectional serological surveys were conducted at year 8 (Y8) and Y10 following vaccination under the NIP with 1 or 2 doses of an inactivated HAV vaccine (Havrix, GSK). Seropositivity (anti-HAV antibody concentration ≥ 15 mIU/mL) rates and antibody geometric mean concentrations (GMCs) were assessed at each serosurvey. Non-inferiority of 1 dose versus 2 doses was also explored. RESULTS: This study (NCT02712359) included 600 and 599 children at Y8 and Y10 post-vaccination, respectively. Seropositivity rates were 74.3% (95% confidence interval [CI]: 69.0; 79.2) and 97.7% (95% CI: 95.3; 99.1) at Y8 and 71.9% (95% CI: 66.4; 76.9) and 96.3% (95% CI: 93.5; 98.2) at Y10, in the 1-dose and 2-dose groups, respectively. Antibody GMCs were lower in the 1-dose versus the 2-dose group in both surveys. Non-inferiority was not demonstrated since the lower limit of the 2-sided 95% CI for the between-group difference in seropositivity rates (1-dose minus 2-dose) was < -10%. CONCLUSION: Anti-HAV antibody persistence was observed in lower percentages of children receiving 1 dose versus 2 doses of Havrix, at 8 and 10 years post-vaccination in Panama. Further investigations are needed to confirm antibody persistence and conclude on the protection afforded beyond 10 years in the pediatric population in Latin America.

Monitoring the marketing, distribution, and use of Sprinkles micronutrient powders in rural western Kenya.

BACKGROUND: In 2007, the US Centers for Disease Control and Prevention partnered with local Kenyan institutions to implement the Nyando Integrated Child Health and Education Project, an effectiveness study that used social marketing and a community-based distribution program to promote the sale of Sprinkles and other health products. OBJECTIVE: To describe monitoring of wholesale sales, household demand, promotional strategies, and perceived factors influencing Sprinkles sales among vendors. METHODS: Ongoing quantitative and qualitative monitoring of Sprinkles sales began in May 2007 in 30 intervention villages. Data sources included baseline and follow-up cross-sectional surveys; office records of Sprinkles sales to vendors; biweekly household monitoring of Sprinkles use; and qualitative data collection, including vendor focus groups and key informant interviews. RESULTS: A total of 550 children aged 6 to 35 months were enrolled at baseline, and 451 were available at 12-month follow-up. During this period, nearly 160,000 sachets were sold wholesale to vendors, with variability in sales influenced by the social, political, and economic context. Vendors living closer to the wholesale office purchased more Sprinkles, so a second office was opened closer to remote vendors. On average, 33% of households purchased Sprinkles during household monitoring visits. Training sessions and community launches were important for community support and raising awareness about Sprinkles. Vendor incentives motivated vendors to sell Sprinkles, and consumer incentives promoted purchases. CONCLUSIONS: Sprinkles program monitoring in Kenya was critically important for understanding sales and distribution trends and vendor perceptions. Understanding these trends led to strategic changes to the intervention over time.

Barriers to vaccination in Latin America: A systematic literature review.

Current vaccination coverage rates in Latin America and the Caribbean (LAC) are lower than the region-wide rates set by the Pan American Health Organization. To improve vaccination uptake, it is crucial to identify barriers to vaccination. We conducted a systematic literature review to identify the key barriers to vaccination in the LAC region, and to classify and quantify factors affecting vaccination coverage using the barrier categories outlined by the Strategic Advisory Group of Experts (SAGE) working group. We mapped knowledge gaps in the understanding of region-specific and population-specific vaccine hesitancy. Nine databases (Medline via PubMed, Web of Science, LILACS, MedCarib, SciELO, Scopus, PATH, SAGE Online and Google Scholar) were searched for articles published in English, Spanish and Portuguese up to 15 July 2017. A total of 6867 articles were identified of which 75 were included in the review. Majority of the articles were quantitative in nature and nearly half from Brazil. Many other countries in LAC have limited published evidence on barriers to vaccination. The most commonly investigated target population was parents (of children <8 years of age [yoa] and adolescents 9-10 yoa) but there was a balance in the number of publications that reported on influenza, childhood and human papillomavirus vaccination. There was limited direct evidence which reported insights on the new generation of childhood vaccines (pneumococcal or meningococcal vaccines) or studies targeting adolescents and pregnant women. Among the SAGE barrier categories, 'individual/group influences' were the most frequently reported barrier category (68%) followed by 'contextual influences' (47%). Adverse socioeconomic factors, a low level of education, lack of awareness of diseases and their vaccines, religious and cultural beliefs are commonly cited as obstacles to vaccination acceptance. Additional evidence is needed to fully understand the barriers to vaccination for different target populations, countries in the region and specific vaccine types.

Incidence and mortality of pertussis disease in infants <12 months of age following introduction of pertussis maternal universal mass vaccination in Bogotá, Colombia.

BACKGROUND: Maternal immunization with tetanus, diphtheria, and acellular pertussis (Tdap) vaccine confers protection to young infants. We aimed to describe trends in pertussis incidence and associated mortality in children aged <12 months before and after introduction of maternal Tdap immunization in Bogotá, Colombia. METHODS: Data on pertussis-related cases/deaths in infants aged <12 months were collected from SIVIGILA for the period 2005-2016, and compared incidence for the pre-vaccine introduction (2005-2012) and post-maternal Tdap vaccination (2014-2016) periods in infants aged <12 months and in three distinct age-strata; ≤6 weeks, 7-<28 weeks, and 28-52 weeks. Mortality comparisons were performed in all infants <12 months. RESULTS: From 2005 to 2016, 2315 laboratory or clinically-confirmed pertussis cases were reported in infants <12 months of age (278 cases in young infants aged ≤6 weeks); 55 pertussis deaths were reported in children aged <12 months. No pertussis deaths were reported in the 2014-2016 period. Since maternal Tdap introduction in 2013, a consistent decline in pertussis incidence and mortality was observed. In the time-series analysis, incidence declined from 209.4/100,000 persons (2005-2012) to 49.1/100,000 persons (2014-2016) in all children <12 months; a 87.5% (95%CI: 77.2-93.2%) reduction. For these same period's incidence in young infants ≤6 weeks declined from 196.7 to 89.6/100,000 person-years (an 54.4% [95% CI: 35.4-67.9%] reduction). Greater incidence reductions were observed in older infants; 73.4% (95% CI: 68.4-77.6%) in those aged 7-<28 weeks, and 100% in those aged 28-52 weeks. A 100% reduction in Pertussis mortality in infants <12 months was observed. Since Tdap introduction, maternal vaccine coverage rose from <60% in 2013-2015 to 80% in 2016. CONCLUSIONS: Implementation of maternal immunization in Bogotá may have contributed to the reduction in pertussis incidence and mortality among infants <12 months of age (ClinicalTrials.gov: NCT02569879). An Audio Summary linked to this article that can be found on Figshare https://doi.org/10.6084/m9.figshare.12943316.

Highlights of an Expert Advisory Board on Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD) in Latin America.

Background: Chronic obstructive pulmonary disease (COPD) is a preventable and usually progressive lung disease that affects millions of people worldwide and is the sixth leading cause of death in the Americas. Viral and bacterial respiratory tract infections and air pollution may cause acute exacerbations of COPD (AE-COPD) ranging from mild, moderate to severe. The greatest proportion of the overall COPD burden on the health system is due to disease exacerbations. There is limited evidence regarding the etiology and burden of AE-COPD in Latin America (LATAM). Methods: To respond to this gap in evidence, an Advisory Board with regional pneumologists and infectious disease experts was convened in September 2018 in Panama City, Panama, to: 1) review the burden of AE-COPD in LATAM; 2) evaluate the etiology of AE-COPD in LATAM; and 3) assess and compare the local/regional guidelines to confirm the etiology, characterize, and manage AE-COPD. Results: The results of the meeting showed that there is a high prevalence of AE-COPD in LATAM countries, limited evidence on etiology data, and discrepancies in the case definitions and symptomology (ie, severity) classifications used in LATAM. Conclusion: The Advisory Board discussions further resulted in recommendations for future research on the impact on the epidemiology and burden of disease, on establishing standardized AE-COPD case definition guidelines, and on studying the etiology of both moderate and severe AE-COPD cases.