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.

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.

Freezing temperatures in the vaccine cold chain: a systematic literature review.

The dangers of accidental freezing of vaccines in the cold chain have prompted studies throughout the globe to better characterize the risk. To date, there has been no systematic review of these studies. This analysis highlights that accidental freezing is pervasive and occurs across all segments of the cold chain. Between 14% and 35% of refrigerators or transport shipments were found to have exposed vaccine to freezing temperatures, while in studies that examined all segments of distribution, between 75% and 100% of the vaccine shipments were exposed. More rigorous study designs were associated with higher levels of freeze exposure. As more expensive, freeze-sensitive vaccines are introduced into immunization schedules, freeze prevention will become increasingly critical for ensuring that the world's children are receiving fully potent vaccine.

Monitoring temperatures in the vaccine cold chain in Bolivia.

This study monitored vaccine cold chain temperatures during routine DTP-HB-Hib vaccine shipments from central stores to 11 communities in 3 provinces of Bolivia. In all 11 monitored shipments, vaccines were exposed to freezing temperatures at one or more points. In each of the shipments, temperatures below 0 degrees C were recorded for 2-50% of the monitoring period. Freezing occurred at almost every level of the cold chain distribution system, especially during district and health center storage and during transport to the province and district levels. Seven of the 11 shipments were exposed to temperatures above 8 degrees C, although none were exposed to excessive heat longer than 1.3% of the total monitoring period.

Hepatitis B vaccination of newborn infants in rural China: evaluation of a village-based, out-of-cold-chain delivery strategy.

OBJECTIVE: To prevent perinatal transmission of hepatitis B virus (HBV), WHO recommends that the first dose of hepatitis B (HepB) vaccine be given within 24 hours after birth. This presents a challenge in remote areas with limited cold-chain infrastructure and where many children are born at home. METHODS: Rural townships in three counties in China's Hunan Province were randomized into three groups with different strategies for delivery of the first dose of HepB vaccine. In group 1, vaccine was stored within the cold chain and administered in township hospitals. In group 2, vaccine was stored out of the cold chain in villages and administered by village-based health workers to infants at home. Group 3 used the same strategy as group 2, but vaccine was packaged in a prefilled injection device. Training of immunization providers and public communication conveying the importance of the birth dose was performed for all groups. FINDINGS: Among children born at home, timely administration (within 24 hours after birth) of the first dose of HepB vaccine increased in all groups after the study: group 1, from 2.4% to 25.2%; group 2, from 2.6% to 51.8%; and group 3, from 0.6% to 66.7%; P < 0.001 in each case. No significant difference in antibody response to vaccine was observed between the groups. CONCLUSION: Timely administration of the first dose of HepB vaccine was improved by communication and training activities, and by out-of-cold-chain storage of vaccine and administration at the village level, especially among children born at home.

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.

Single-dose versus multi-dose vaccine vials for immunization programmes in developing countries.

Excessive vaccine wastage and safety concerns have prompted the international health community to develop and supply vaccines in formats other than the standard multi-dose vial. This article presents a programmatic and economic comparison of the major differences between the multi-dose vials and single-dose formats used for immunization services in developing countries. Multi-dose vials, in general, sell at a lower per-dose price and occupy less cold-chain capacity than single-dose formats. However, higher wastage rates may offset these benefits, especially for more expensive vaccines. Single-dose formats offer several important programmatic benefits, such as increased vaccination opportunities and improved vaccine safety. One single-dose format, the prefilled auto-disable (AD) device, provides additional injection safety and convenience features because it physically combines the vaccine and AD syringe. Selecting the appropriate vaccine presentation will depend on many factors. However, multi-dose vials are likely to be most appropriate for cheaper vaccines and in settings where cold-chain storage capacity is restricted. Single-dose formats will be most appropriate for more expensive vaccines and where there are problems with unsafe injection practices. Prefilled AD injection devices will be particularly useful in expanding outreach services while eliminating the possibility of needle reuse.

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.

A prefilled injection device for outreach tetanus immunization by Bolivian traditional birth attendants / Vacunación antitetánica extrainstitucional por parteras empíricas bolivianas mediante dispositivos desechables de una sola dosis

This study evaluated the performance, acceptability, and appropriateness of a new, single-use, prefilled injection device called UniJect™ for an outreach immunization application.6 Between April and June 1995, UniJect devices were used by 36 traditional birth attendants to administer tetanus toxoid injections to 2 240 pregnant women during routine, antenatal home visits in the Northern, Ichilos, and Warnes Districts of Santa Cruz, Bolivia. Because tetanus toxoid is relatively heat stable, the traditional birth attendants were able to keep the tetanus toxoid-filled UniJect devices in their homes for up to one month without refrigeration. The devices were stored, transported, and disposed of in an outreach carrier designed to reduce the risks of improper handling and disposal. Data were collected from injection recipients, traditional birth attendants, and supervisors via observation, questionnaires, and post-study interviews. The performance of the UniJect device and its acceptability among all groups was very high. The traditional birth attendants used UniJect properly and safely; there were no reports or observations of device misuse, reuse, or needle-stick. Advantages cited included the fact that the device required no assembly, offered assured sterility, and reduced vaccine wastage sometimes associated with multi-dose vials. The ability to store and transport the vaccine-filled devices without ice also greatly simplified logistics.

En este estudio se evaluaron el rendimiento, la aceptabilidad y la conveniencia de la inmunización antitetánica extrainstitucional con un nuevo dispositivo hipodérmico de una sola dosis, el UniJect®. De abril a junio de 1995, el dispositivo UniJect aprestado de fábrica con una sola dosis de toxoide tetánico fue utilizado por 36 parteras tradicionales para vacunar a 2 240 mujeres embarazadas durante las visitas domiciliarias prenatales de rutina en los distritos Norte, Ichilos y Warnes de Santa Cruz, Bolivia. Ya que el toxoide tetánico es termoestable, las parteras pudieron mantener los dispositivos UniJect sin refrigeración en sus hogares por un período de hasta un mes. Los UniJect se guardaron, transportaron y desecharon en portadores extrainstitucionales diseñados para reducir los riesgos de manipularlos y desecharlos de forma inadecuada. Se recolectaron datos de las mujeres vacunadas, las parteras tradicionales y sus supervisores, mediante observación, cuestionarios y entrevistas realizadas después del estudio. Todos los grupos consideraron muy satisfactorios el rendimiento y la aceptabilidad del dispositivo UniJect. Las parteras tradicionales lo usaron de forma apropiada y cuidadosa; no hubo informes ni observaciones de mala utilización, reúso o puntazos accidentales. Se mencionaron, como ventajas del dispositivo, que no requiere montaje, asegura la esterilidad y reduce el desperdicio de vacuna que a veces ocurre con las ampollas de dosis múltiples. Además, todo el procedimiento se simplifica porque los dispositivos pueden almacenarse y transportarse sin necesidad de hielo.