Reuse prevention syringes for reconstitution of lyophilized vaccines: Operational study and UNICEF plans for expanding introduction.

Since the 1990s, the United Nation's Children's Fund has encouraged injection safety for immunizations through bundling vaccines with appropriate amounts of supporting equipment and by supplying autodisable (AD) syringes for injections. However, poor vaccine reconstitution practices continue to be reported worldwide. By 2009, UNICEF will begin to phase out the distribution of standard disposable syringes for vaccine reconstitution and replace them with reuse prevention (RUP) syringes, with a full transition expected by the end of 2010. A field evaluation in Indonesia was conducted to identify introduction requirements, issues with healthcare worker training and acceptance, and RUP syringe performance and safety. Managers and health workers felt that RUP syringes improved injection safety and fit easily into country logistical systems. Healthcare workers felt they were intuitive to use, but recommended special training. The integration of RUP reconstitution syringes by UNICEF could increase injection safety by preventing the reuse of syringes and reducing vaccine contamination.

Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children: hamlet-randomised vaccine-probe trial.

BACKGROUND: Most studies of Haemophilus influenzae type b (Hib) disease in Asia have found low rates, and few Asian countries use Hib vaccine in routine immunisation programmes. Whether Hib disease truly is rare or whether many cases remain undetected is unclear. METHODS: To estimate incidences of vaccine-preventable Hib pneumonia and meningitis among children younger than 2 years in Lombok, Indonesia, during 1998-2002, we undertook a hamlet-randomised, controlled, double-blind vaccine-probe study (818 hamlets). Children were immunised (WHO schedule) with diphtheria, tetanus, pertussis (DTP) or DTP-PRP-T (Hib conjugate) vaccine. Vaccine-preventable disease incidences were calculated as the difference in rates of clinical outcomes between DTP and DTP-PRP-T groups. Analyses included all children who received at least one vaccine dose. FINDINGS: We enrolled 55073 children: 28147 were assigned DTP-PRP-T and 26926 DTP. The proportion of pneumonia outcomes prevented by vaccine ranged from less than 0 to 4.8%. Calculated incidences of vaccine-preventable Hib disease (per 10(5) child-years of observation) for outcome categories were: substantial alveolar consolidation or effusion, less than zero (-43 [95% CI -185 to 98]); all severe pneumonia, 264 (95% CI less than zero to 629); all clinical pneumonia, 1561 (270 to 2853); confirmed Hib meningitis, 16 (1.4 to 31); meningitis with cerebrospinal-fluid findings consistent with a bacterial aetiology, 67 (22 to 112); and admission for suspected meningitis or presenting to a clinic with convulsions, 158 (42 to 273). INTERPRETATION: Hib vaccine did not prevent the great majority of pneumonia cases, including those with alveolar consolidation. These results do not support a major role for Hib vaccine in overall pneumonia-prevention programmes. Nevertheless, the study identified high incidences of Hib meningitis and pneumonia; inclusion of Hib vaccine in routine infant immunisation programmes in Asia deserves consideration.

Incidence and clinical features of hospitalization because of respiratory syncytial virus lower respiratory illness among children less than two years of age in a rural Asian setting.

BACKGROUND: Lower respiratory illness is the leading cause of child death in the developing world. Despite this few reports on respiratory syncytial virus (RSV) lower respiratory illness disease burden exist from rural areas of the developing world, and none exist for Indonesia. METHODS: We evaluated children living in any of 83 villages on Lombok Island, Indonesia who were <2 years of age when hospitalized for severe lower respiratory illness during 2000 and 2001. All hospitals on Lombok were included in the evaluation. We obtained the number of births and deaths that occurred within the study villages and time frame, allowing for incidence determination. RESULTS: Of 2677 children hospitalized for severe lower respiratory illness whose RSV status was determined, 23% had a positive test; this percentage varied from 50% at the end of the rainy season to 0% shortly before the start of the rainy season. Among children <2 years of age, the confirmed and estimated incidences of severe RSV lower respiratory illness hospitalization were 10 and 14 per 1000 child-years, respectively; values for children <1 year of age were 17 and 25 per 1000 child-years. The confirmed case-fatality percentage among RSV-positive cases was 1.9%; however, 84% of children who died were dead before RSV status could be determined, suggesting the actual case fatality percentage was higher. CONCLUSIONS: Lombok has a large burden of severe childhood RSV lower respiratory illness, and death occurs frequently. Novel RSV vaccines thus could have a substantial positive impact on lower respiratory illness morbidity and mortality.

Acute respiratory illness incidence and death among children under two years of age on Lombok Island, Indonesia.

No childhood pneumonia incidence data for Indonesia exist, and few data exist for Asia as a whole. From February 1, 1998, to January 31, 1999, we conducted acute respiratory illness (ARI) surveillance among children < 24 months of age in 50 mainly rural villages on Lombok Island, Indonesia. The total number of child-years at risk during the study period was 17,015. The documented incidences of simple, severe, hospitalized, and radiologically confirmed alveolar pneumonia were 21, 8.3, 5.3, and 1.8 per 100 child-years of observation, respectively. For all outcomes, the incidence was higher among younger and rural children. All cause and ARI-specific infant mortality rates were 84 and 33 per 1,000 live births, respectively. More than 65% of deaths due to ARI occurred outside of a hospital setting. The incidence of pneumonia is high in Lombok. Interventions should include introducing vaccines to prevent infections leading to pneumonia and increasing the access of critically ill infants to the health care system.

Outcome and extent of disability following Japanese encephalitis in Indonesian children.

OBJECTIVES: The study aimed to assess outcome, including level of disability, following Japanese encephalitis (JE) in children in Indonesia. METHODS: A cohort of children diagnosed with laboratory-confirmed JE from January 2005 to August 2006 was followed-up, with disability measured at least 4 months after discharge from hospital. An assessment tool that can be used to rapidly determine practical level of disability and the likelihood that a child will be able to live independently after illness, the Liverpool Outcome Score, was used. RESULTS: Of 72 children with JE, determination of outcome was possible for 65 (90%). Sixteen died in hospital or before follow-up assessment (25%). Sixteen children (25%) had severe sequelae, indicating their function was impaired enough to likely make them dependent. Five (7%) had moderate sequelae and 12 (18%) had minor sequelae. The remaining 16 children (25%) were considered to have recovered fully. CONCLUSIONS: Half of the children with JE either died or were left with serious disabilities likely to impair their ability to lead independent lives, demonstrating the severe impact of JE. Immunization can effectively prevent JE, and an immunization program could avert some of the economic and social burden of JE disease in Indonesia.

Confirmation of Japanese encephalitis as an endemic human disease through sentinel surveillance in Indonesia.

Japanese encephalitis (JE) results in significant mortality and disability in children in Asia. In Indonesia, despite recognition of JE virus transmission, reports of human disease have been few and from limited geographic areas. Hospital-based surveillance for acute encephalitis syndrome (AES) and JE in children 15 years of age and under was undertaken in 15 hospitals in six provinces from 2005 to 2006. High- and low-risk provinces in geographically dispersed areas were included. Health center-based surveillance also was undertaken in one province. Eighty-two JE cases were confirmed among 1,496 AES cases detected. JE cases were confirmed in all provinces, but the proportion varied between 18% and 2% among provinces of different risk levels. Children younger than 10 years of age represented 95% of JE cases, and 47% of all cases either died or were disabled. The study shows JE is an endemic human disease across Indonesia. Immunization strategies are being considered.

The costs of home delivery of a birth dose of hepatitis B vaccine in a prefilled syringe in Indonesia.

OBJECTIVE: To provide global policy-makers with decision-making information for developing strategies for immunization of infants with a birth dose of hepatitis B vaccine, this paper presents a retrospective cost analysis, conducted in Indonesia, of delivering this vaccine at birth using the Uniject prefill injection device. METHODS: Incremental costs or cost savings associated with changes in the hepatitis B immunization programme were calculated using sensitivity analysis to vary the estimates of vaccine wastage rates and prices for vaccines and injection devices, for the birth dose of hepatitis B vaccine. FINDINGS: The introduction of hepatitis B vaccine prefilled in Uniject (HB-Uniject) single-dose injection devices for use by midwives for delivering the birth dose is cost-saving when the wastage rate for multidose vials is greater than 33% (Uniject is a trademark of BD, Franklin Lakes, NJ, USA). CONCLUSION: The introduction of HB-Uniject for birth-dose delivery is economically worthwhile and can increase coverage of the critical birth dose, improve resource utilization, reduce transmission of hepatitis B and promote injection safety.

Hepatitis B vaccine freezing in the Indonesian cold chain: evidence and solutions.

OBJECTIVES: To document and characterize freezing temperatures in the Indonesian vaccine cold chain and to evaluate the feasibility of changes designed to reduce the occurrence of freezing. METHODS: Data loggers were used to measure temperatures of shipments of hepatitis B vaccine from manufacturer to point of use. Baseline conditions and three intervention phases were monitored. During each of the intervention phases, vaccines were removed progressively from the standard 2-8 degrees C cold chain. FINDINGS: Freezing temperatures were recorded in 75% of baseline shipments. The highest rates of freezing occurred during transport from province to district, storage in district-level ice-lined refrigerators, and storage in refrigerators in health centres. Interventions reduced freezing, without excessive heat exposure. CONCLUSIONS: Inadvertent freezing of freeze-sensitive vaccines is widespread in Indonesia. Simple strategies exist to reduce freezing - for example, selective transport and storage of vaccines at ambient temperatures. The use of vaccine vial monitors reduces the risk associated with heat-damaged vaccines in these scenarios. Policy changes that allow limited storage of freeze-sensitive vaccines at temperatures >2-8 degrees C would enable flexible vaccine distribution strategies that could reduce vaccine freezing, reduce costs, and increase capacity.